Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-30 @ 9:30 AM
Study NCT ID:
NCT01086033
Status:
COMPLETED
Last Update Posted:
2013-09-26
First Post:
2010-02-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A 3-year Study Following up Patients With Moderate to Severe Rheumatoid Arthritis Treated With Humira in Greece
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie (prior sponsor, Abbott)'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '3 years', 'eventGroups': [{'id': 'EG000', 'title': 'Humira', 'description': 'Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.', 'otherNumAtRisk': 566, 'otherNumAffected': 109, 'seriousNumAtRisk': 566, 'seriousNumAffected': 65}], 'otherEvents': [{'term': 'Drug ineffective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 91}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 35}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lymph nodes enlarged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Thrombotic thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Acute myocardial infarction/Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cardiac failure aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Paroxysmal upraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Colitis ulcerative aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Epigastric pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastrointestinal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypochondrium pain right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypogastric pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pancreatic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Paresthesia circumoral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fever/Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 7}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Weakness/Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 4}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Difficulty in walking', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Drug ineffective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Edema abdomen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Edema of legs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nodule on finger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Reaction unevaluable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gallbladder perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anaphylaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abscesses of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Periapical dental abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Perirectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Peritonsillar abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Phlegmon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Post operative infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Relapsing fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Septic arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tuberculous peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Viral hepatitis B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Automobile Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bimalleolar fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Elbow fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Postoperative hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Shoulder fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Weight Loss/Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Creatine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Erythrocyte sedimentation rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hematocrit decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Transaminases increased/Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'RA flare up', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pain in hip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arthritis single joint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hydrarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Intervertebral disc herniation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lumbar disc herniation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lupus-like syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Periarticular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Polyarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Synovial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Wrist deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Acute myelomonocytic leukemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Collecting duct renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lung Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lung nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ovarian germ cell cancer stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Parathyroid adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Demyelinating disease (excl. multiple sclerosis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Movements reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nephrotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Throat pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hair loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Maculopapular rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cholecystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fusion lumbar spine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Removal of surgical hardware', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '566', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Humira', 'description': 'Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.'}], 'classes': [{'title': 'Any Adverse Event', 'categories': [{'measurements': [{'value': '262', 'groupId': 'OG000'}]}]}, {'title': 'Serious Adverse Event', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.\n\nIf an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death, is life-threatening, results in hospitalization or the prolongation of hospitalization, is a congenital anomaly or a persistent or significant disability/incapacity, is an event that results in a condition that substantially interferes with the activities of daily living of the participant, is an important medical event requiring medical or surgical intervention to prevent a serious outcome, spontaneous abortion or miscarriage experienced by the participant, or an elective abortion performed on the participant.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population, including all patients that received at least one dose of the study drug.'}, {'type': 'PRIMARY', 'title': 'Disease Activity Score (DAS) 28 Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '566', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Humira', 'description': 'Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.'}], 'classes': [{'title': 'Baseline (n=555)', 'categories': [{'measurements': [{'value': '6.0', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=510)', 'categories': [{'measurements': [{'value': '4.2', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=449)', 'categories': [{'measurements': [{'value': '3.8', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (n=401)', 'categories': [{'measurements': [{'value': '3.5', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=379)', 'categories': [{'measurements': [{'value': '3.5', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 18 (n=333)', 'categories': [{'measurements': [{'value': '3.3', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 24 (n=298)', 'categories': [{'measurements': [{'value': '3.2', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 30 (n=264)', 'categories': [{'measurements': [{'value': '3.0', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 36 (n=254)', 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36', 'description': 'The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \\>5.1 indicates high disease activity, a DAS28 score \\<3.2 indicates low disease activity, and a DAS28 score \\<2.6 indicates clinical remission.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; "n" indicates the number of participants with available data at each time point.'}, {'type': 'PRIMARY', 'title': 'European League Against Rheumatism (EULAR) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '566', 'groupId': 'OG000'}, {'value': '566', 'groupId': 'OG001'}, {'value': '566', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Good Response', 'description': 'Rheumatoid Arthritis patients treated with Humira (adalimumab) with a Good Response per EULAR criteria.'}, {'id': 'OG001', 'title': 'Moderate Response', 'description': 'Rheumatoid Arthritis patients treated with Humira (adalimumab) with a Moderate Response per EULAR criteria.'}, {'id': 'OG002', 'title': 'No Response', 'description': 'Rheumatoid Arthritis patients treated with Humira (adalimumab) with No Response according to EULAR criteria.'}], 'classes': [{'title': 'Month 3 (n=501)', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}]}]}, {'title': 'Month 6 (n=443)', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}]}, {'title': 'Month 9 (n=394)', 'categories': [{'measurements': [{'value': '173', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}]}, {'title': 'Month 12 (n=373)', 'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}]}, {'title': 'Month 18 (n=327)', 'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}]}, {'title': 'Month 24 (n=294)', 'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}]}, {'title': 'Month 30 (n=262)', 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': 'Month 36 (n=253)', 'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36', 'description': 'A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity.\n\nA Good EULAR Response is defined as an improvement (decrease) in the DAS28 of \\> 1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2.\n\nA Moderate EULAR Response is defined as either:\n\n* an improvement (decrease) in the DAS28 of \\> 0.6 and ≤ 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1, or\n* an improvement (decrease) in the DAS28 of \\> 1.2 from Baseline and attainment of a DAS28 score of \\> 3.2.\n\nNo Response is defined as either:\n\n* an improvement (decrease) in the DAS28 of ≤ to 0.6, or\n* an improvement (decrease) in the DAS28 of \\> 0.6 and ≤ 1.2 and attainment of a DAS28 of \\> 5.1.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population;'}, {'type': 'PRIMARY', 'title': 'Number of Participants With an American College of Rheumatology (ACR) 20 Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '566', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Humira', 'description': 'Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.'}], 'classes': [{'title': 'Month 3 (n=491)', 'categories': [{'measurements': [{'value': '265', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=427)', 'categories': [{'measurements': [{'value': '279', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (n=384)', 'categories': [{'measurements': [{'value': '263', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=363)', 'categories': [{'measurements': [{'value': '248', 'groupId': 'OG000'}]}]}, {'title': 'Month 18 (n=330)', 'categories': [{'measurements': [{'value': '241', 'groupId': 'OG000'}]}]}, {'title': 'Month 24 (n=293)', 'categories': [{'measurements': [{'value': '216', 'groupId': 'OG000'}]}]}, {'title': 'Month 30 (n=259)', 'categories': [{'measurements': [{'value': '198', 'groupId': 'OG000'}]}]}, {'title': 'Month 36 (n=248)', 'categories': [{'measurements': [{'value': '194', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36', 'description': "American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:\n\n* ≥ 20% improvement in tender joint count;\n* ≥ 20% improvement in swollen joint count; and\n* ≥ 20% improvement in at least 3 of the 5 following parameters:\n\n * Patient's assessment of pain (measured on a 100 mm visual analog scale \\[VAS\\]);\n * Patient's global assessment of disease activity (measured on a 100 mm VAS);\n * Physician's global assessment of disease activity (measured on a 100 mm VAS);\n * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]);\n * Acute phase reactant value (C-reactive protein \\[CRP\\]).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; the analysis was performed on the basis of non-missing information and no imputation methods were used. "n" indicates the number of patients for whom ACR20 could be calculated at each time point.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With an American College of Rheumatology (ACR) 50 Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '566', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Humira', 'description': 'Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.'}], 'classes': [{'title': 'Month 3 (n=498)', 'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=433)', 'categories': [{'measurements': [{'value': '188', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (n=388)', 'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=368)', 'categories': [{'measurements': [{'value': '182', 'groupId': 'OG000'}]}]}, {'title': 'Month 18 (n=333)', 'categories': [{'measurements': [{'value': '184', 'groupId': 'OG000'}]}]}, {'title': 'Month 24 (n=291)', 'categories': [{'measurements': [{'value': '170', 'groupId': 'OG000'}]}]}, {'title': 'Month 30 (n=256)', 'categories': [{'measurements': [{'value': '161', 'groupId': 'OG000'}]}]}, {'title': 'Month 36 (n=250)', 'categories': [{'measurements': [{'value': '164', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36', 'description': "American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:\n\n* ≥ 50% improvement in tender joint count;\n* ≥ 50% improvement in swollen joint count; and\n* ≥ 50% improvement in at least 3 of the 5 following parameters:\n\n * Patient's assessment of pain (measured on a 100 mm visual analog scale \\[VAS\\]);\n * Patient's global assessment of disease activity (measured on a 100 mm VAS);\n * Physician's global assessment of disease activity (measured on a 100 mm VAS);\n * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]);\n * Acute phase reactant value (C-reactive protein \\[CRP\\]).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; the analysis was performed on the basis of non-missing information and no imputation methods were used. "n" indicates the number of patients for whom ACR50 could be calculated at each time point.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With an American College of Rheumatology (ACR) 70 Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '566', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Humira', 'description': 'Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.'}], 'classes': [{'title': 'Month 3 (n=495)', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=435)', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (n=390)', 'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=373)', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}]}]}, {'title': 'Month 18 (n=330)', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}]}]}, {'title': 'Month 24 (n=294)', 'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}]}]}, {'title': 'Month 30 (n=261)', 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}]}]}, {'title': 'Month 36 (n=253)', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36', 'description': "American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:\n\n* ≥ 70% improvement in tender joint count;\n* ≥ 70% improvement in swollen joint count; and\n* ≥ 70% improvement in at least 3 of the 5 following parameters:\n\n * Patient's assessment of pain (measured on a 100 mm visual analog scale \\[VAS\\]);\n * Patient's global assessment of disease activity (measured on a 100 mm VAS);\n * Physician's global assessment of disease activity (measured on a 100 mm VAS);\n * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]);\n * Acute phase reactant value (C-reactive protein \\[CRP\\]).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; the analysis was performed on the basis of non-missing information and no imputation methods were used. "n" indicates the number of patients for whom ACR70 could be calculated at each time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Missed at Least One Dose of Humira', 'denoms': [{'units': 'Participants', 'counts': [{'value': '566', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Humira', 'description': 'Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.'}], 'classes': [{'title': 'Month 3 (n=512)', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=451)', 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 9 (n=406)', 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=384)', 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 18 (n=341)', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 24 (n=303)', 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 30 (n=271)', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 36 (n=262)', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 3, 6, 9, 12, 18, 24, 30, and 36', 'description': 'Compliance to study treatment was measured by the percentage of participants who missed at least one dose of Humira during each time interval between study visits.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; "n" indicates the number of participants with available data at each time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Humira', 'description': 'Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '566'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '262'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '304'}]}], 'dropWithdraws': [{'type': 'Lack of efficacy/Exacerbation of RA', 'reasons': [{'groupId': 'FG000', 'numSubjects': '86'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '86'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'AE and Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Withdrew Consent and Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Withdrew consent and Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'AE and Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'AE and Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'AE and Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'AE, Withdrew Consent & Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '566', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Humira', 'description': 'Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.8', 'spread': '13.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '456', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '110', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Greece', 'categories': [{'measurements': [{'value': '566', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 566}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-24', 'studyFirstSubmitDate': '2010-02-26', 'resultsFirstSubmitDate': '2013-07-17', 'studyFirstSubmitQcDate': '2010-03-11', 'lastUpdatePostDateStruct': {'date': '2013-09-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-09-24', 'studyFirstPostDateStruct': {'date': '2010-03-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': '3 years', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.\n\nIf an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death, is life-threatening, results in hospitalization or the prolongation of hospitalization, is a congenital anomaly or a persistent or significant disability/incapacity, is an event that results in a condition that substantially interferes with the activities of daily living of the participant, is an important medical event requiring medical or surgical intervention to prevent a serious outcome, spontaneous abortion or miscarriage experienced by the participant, or an elective abortion performed on the participant.'}, {'measure': 'Disease Activity Score (DAS) 28 Over Time', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36', 'description': 'The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \\>5.1 indicates high disease activity, a DAS28 score \\<3.2 indicates low disease activity, and a DAS28 score \\<2.6 indicates clinical remission.'}, {'measure': 'European League Against Rheumatism (EULAR) Response', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36', 'description': 'A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity.\n\nA Good EULAR Response is defined as an improvement (decrease) in the DAS28 of \\> 1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2.\n\nA Moderate EULAR Response is defined as either:\n\n* an improvement (decrease) in the DAS28 of \\> 0.6 and ≤ 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1, or\n* an improvement (decrease) in the DAS28 of \\> 1.2 from Baseline and attainment of a DAS28 score of \\> 3.2.\n\nNo Response is defined as either:\n\n* an improvement (decrease) in the DAS28 of ≤ to 0.6, or\n* an improvement (decrease) in the DAS28 of \\> 0.6 and ≤ 1.2 and attainment of a DAS28 of \\> 5.1.'}, {'measure': 'Number of Participants With an American College of Rheumatology (ACR) 20 Response', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36', 'description': "American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:\n\n* ≥ 20% improvement in tender joint count;\n* ≥ 20% improvement in swollen joint count; and\n* ≥ 20% improvement in at least 3 of the 5 following parameters:\n\n * Patient's assessment of pain (measured on a 100 mm visual analog scale \\[VAS\\]);\n * Patient's global assessment of disease activity (measured on a 100 mm VAS);\n * Physician's global assessment of disease activity (measured on a 100 mm VAS);\n * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]);\n * Acute phase reactant value (C-reactive protein \\[CRP\\])."}, {'measure': 'Number of Participants With an American College of Rheumatology (ACR) 50 Response', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36', 'description': "American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:\n\n* ≥ 50% improvement in tender joint count;\n* ≥ 50% improvement in swollen joint count; and\n* ≥ 50% improvement in at least 3 of the 5 following parameters:\n\n * Patient's assessment of pain (measured on a 100 mm visual analog scale \\[VAS\\]);\n * Patient's global assessment of disease activity (measured on a 100 mm VAS);\n * Physician's global assessment of disease activity (measured on a 100 mm VAS);\n * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]);\n * Acute phase reactant value (C-reactive protein \\[CRP\\])."}, {'measure': 'Number of Participants With an American College of Rheumatology (ACR) 70 Response', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36', 'description': "American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:\n\n* ≥ 70% improvement in tender joint count;\n* ≥ 70% improvement in swollen joint count; and\n* ≥ 70% improvement in at least 3 of the 5 following parameters:\n\n * Patient's assessment of pain (measured on a 100 mm visual analog scale \\[VAS\\]);\n * Patient's global assessment of disease activity (measured on a 100 mm VAS);\n * Physician's global assessment of disease activity (measured on a 100 mm VAS);\n * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]);\n * Acute phase reactant value (C-reactive protein \\[CRP\\])."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Missed at Least One Dose of Humira', 'timeFrame': 'Months 3, 6, 9, 12, 18, 24, 30, and 36', 'description': 'Compliance to study treatment was measured by the percentage of participants who missed at least one dose of Humira during each time interval between study visits.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Evaluation of safety and efficacy', 'Adalimumab treatment', 'Rheumatoid Arthritis'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://rxabbvie.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The objectives of the study are to observe and assess the long-term use, safety and efficacy of Humira (adalimumab), as prescribed by the rheumatologist in a normal clinical setting and in accordance with the terms of the European marketing authorization and to observe compliance of patients with the prescribed treatment.', 'detailedDescription': "This is a multi-center, uncontrolled observational study of patients who at the time of entry had moderate to severe rheumatoid arthritis (RΑ) and who were subsequently prescribed Humira (adalimumab) following normal clinical practice, with or without other anti-rheumatic treatments, prior to enrollment in this study.\n\nOnce the physician has determined that the patient meets the inclusion criteria, and the patient has agreed to be included in the observational study by signing the informed consent, the patient's Day 1 demographic data, and disease status will be reported in the Day 1 Data Report Forms. The physician will then follow-up with the patient via regular office visits at intervals as determined by routine clinical practice. Patient's safety and efficacy data, if they are part of clinical routine, will be recorded in the Data Report Forms at Day 1, and regular visits which are closest to Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Rheumatoid Arthritis on Humira (adalimimab) treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with moderate or severe active rheumatoid arthritis, who have been prescribed and are receiving Humira (adalimumab) under normal clinical practice for at least one month prior to inclusion and according to the approved Summary of Product Characteristics (SPC) in the European Union.\n* Patients must be willing to consent to data being collected and provided to Abbott Laboratories.\n\nExclusion Criteria:\n\n* Contraindications according to the SPC.\n* Patients should not participate in another observational Abbott study.'}, 'identificationModule': {'nctId': 'NCT01086033', 'briefTitle': 'A 3-year Study Following up Patients With Moderate to Severe Rheumatoid Arthritis Treated With Humira in Greece', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A 3-year Post-marketing Observational Study Following up Patients With Moderate to Severe RA Treated With Humira in Greece', 'orgStudyIdInfo': {'id': 'PMOS GREC 2004 06'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Humira', 'description': 'Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'A. Glyfada', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 30116'}, {'zip': '17121', 'city': 'Ag. Dimitrios, Athens', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 47544', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '15343', 'city': 'Ag. Paraskevi, Athens', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 47542', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '68100', 'city': 'Alexandroupoli', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 29915', 'geoPoint': {'lat': 40.84995, 'lon': 25.87644}}, {'zip': '47100', 'city': 'Arta', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 30118', 'geoPoint': {'lat': 39.16014, 'lon': 20.98561}}, {'zip': '10444', 'city': 'Athens', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 29989', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '115 21', 'city': 'Athens', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 29914', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '115 25', 'city': 'Athens', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 29950', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '115 25', 'city': 'Athens', 'country': 'Greece', 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'lon': 23.72379}}, {'city': 'Ágioi Anárgyroi', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 29954', 'geoPoint': {'lat': 38.03013, 'lon': 23.72379}}, {'zip': '34100', 'city': 'Chalcis', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 30198', 'geoPoint': {'lat': 38.46354, 'lon': 23.60284}}, {'zip': '15562', 'city': 'Cholargós', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 30789', 'geoPoint': {'lat': 38.0, 'lon': 23.8}}, {'zip': '71201', 'city': 'Crete', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 30008'}, {'zip': '74100', 'city': 'Crete', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 30210'}, {'city': 'Crete', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 29828'}, {'zip': '66100', 'city': 'Drama', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 30105', 'geoPoint': {'lat': 41.15283, 'lon': 24.1473}}, {'zip': '19200', 'city': 'Elefsina', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 29820', 'geoPoint': {'lat': 38.04135, 'lon': 23.54295}}, {'city': 'Ermoupolis Syros', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 30146'}, {'zip': '70013', 'city': 'Heraklion Crete', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 30767'}, {'zip': '45500', 'city': 'Ioannina', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 30482', 'geoPoint': {'lat': 39.66341, 'lon': 20.85187}}, {'zip': '43100', 'city': 'Karditsa', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 47322', 'geoPoint': {'lat': 39.36485, 'lon': 21.92191}}, {'city': 'Katerini', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 29850', 'geoPoint': {'lat': 40.26956, 'lon': 22.50608}}, {'zip': '65302', 'city': 'Kavala', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 30189', 'geoPoint': {'lat': 40.93959, 'lon': 24.40687}}, {'zip': '14500', 'city': 'Kifissia', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 30476', 'geoPoint': {'lat': 38.07438, 'lon': 23.81106}}, {'zip': '50100', 'city': 'Kozani', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 30004', 'geoPoint': {'lat': 40.29931, 'lon': 21.78984}}, {'zip': '35100', 'city': 'Lamia', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 29993', 'geoPoint': {'lat': 38.89947, 'lon': 22.4335}}, {'zip': '411 10', 'city': 'Larissa', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 30770', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'zip': '41223', 'city': 'Larissa', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 29988', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'zip': '18454', 'city': 'Nikaia', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 29922', 'geoPoint': {'lat': 37.96667, 'lon': 23.65}}, {'zip': '26221', 'city': 'Pátrai', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 29972', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}, {'zip': '26335', 'city': 'Pátrai', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 29916', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}, {'zip': '12134', 'city': 'Peristeri', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 29827', 'geoPoint': {'lat': 38.01539, 'lon': 23.69187}}, {'city': 'Pýrgos', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 29936', 'geoPoint': {'lat': 37.67513, 'lon': 21.44102}}, {'zip': '265 00', 'city': 'Rion, Patras', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 30200'}, {'zip': '54622', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 29900', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '54622', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 30192', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '54623', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 30165', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '54636', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 30765', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '54639', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 29845', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '54642', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 30791', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '54642', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 30792', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '54643', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 47543', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '55134', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 29924', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '564 29', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 30477', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '570 10', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 29947', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '42100', 'city': 'Trikala', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 30115', 'geoPoint': {'lat': 39.55493, 'lon': 21.76837}}, {'city': 'Véria', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 30084', 'geoPoint': {'lat': 37.19027, 'lon': 22.55173}}, {'zip': '67100', 'city': 'Xánthi', 'country': 'Greece', 'facility': 'Site Reference ID/Investigator# 29968', 'geoPoint': {'lat': 41.13488, 'lon': 24.888}}], 'overallOfficials': [{'name': 'Thanasis Floros, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'AbbVie Pharmaceuticals S.A.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie (prior sponsor, Abbott)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}