Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-01-07 @ 11:50 AM
Study NCT ID:
NCT03261102
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-25
First Post:
2017-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TDM Guided Early Optimization of ADAL in Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068879', 'term': 'Adalimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Some of the participants, care providers and investigators will eventually, in the course of the study, have knowledge of the arm they were assigned.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2017-08-22', 'studyFirstSubmitQcDate': '2017-08-22', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects who achieved remission', 'timeFrame': 'Week 12', 'description': 'Clinical remission will be scored by a Harvey-Bradshaw Index \\< 5 AND Biochemical remission will be scored by C-reactive protein \\< 5 mg/l OR Fecal calprotectin \\<250 μg/g (combination endpoint)'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects who achieved clinical response', 'timeFrame': 'From Week 0 to Week 12', 'description': 'Clinical response will be evaluated by a decreased in Harvey-Bradshaw Index score AND a decreased level of C-reactive protein OR Fecal calprotectin'}, {'measure': 'Therapeutic drug monitoring', 'timeFrame': 'At Week 8, 12', 'description': 'Adalimumab drug concentration at week 8 and 12 AND proportion of subjects with antibody to Adalimumab at Week 8 and 12 on the rate i. Clinical response/remission (HBI\\<5) ii. Biochemical response/remission (CRP within normal reference range) iii. Endoscopic response (SES-CD reduction of ≥50% from baseline) / remission (SES-CD ≤3)'}, {'measure': 'Proportion of steroid free subjects', 'timeFrame': 'At Week 12', 'description': 'Steroid free defined as patients being steroid free at Week 12'}, {'measure': 'Subjects well-being', 'timeFrame': 'From Week 0 to Week 12', 'description': 'Subjects well-being will be scored using the validated questionnaire Short inflammatory bowel disease questionnaire (SIBDQ)'}, {'measure': 'Rates of complications', 'timeFrame': '12 weeks', 'description': 'Rates of complications, including hospitalization, surgery, adverse reaction, and corticosteroid use.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IBD', 'Crohn', 'adalimumab', 'ADAL'], 'conditions': ['Crohn Disease', 'Drug Monitoring', 'Inflammatory Bowel Diseases']}, 'descriptionModule': {'briefSummary': "To investigate the influence of early therapeutic drug monitoring and dose optimization on disease outcome in Crohn's patients treated with Adalimumab.", 'detailedDescription': 'This is an investigator initiated randomized open label study. This study is designed to compare whether increasing the dose of adalimumab based on the level the drug in the blood to a target level early in the treatment course would lead to better outcomes for patients as compared to the standard doses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 or older.\n* Crohn's disease diagnosed based on standard objective methodology (clinical, biochemical, endoscopic, histological and radiological correlation).\n* Active disease based on Harvey Bradshaw Index (HBI \\>5) and elevated C-reactive protein (CRP) (\\>normal reference range for local laboratory) OR fecal calprotectin (FCP) (\\>250 µg/g)\n* Due to commence treatment with ADAL.\n\nExclusion Criteria:\n\n* Severe co-existing cardiopulmonary, hepatic, renal, neurologic, or rheumatologic disease.\n* History of active HIV, hepatitis B or C infection,\n* Patients with ileostomy/colostomy, ileal-pouch anal anastomosis or severe perianal fistulising disease.\n* Pregnancy\n* Prior exposure to ADAL"}, 'identificationModule': {'nctId': 'NCT03261102', 'briefTitle': "TDM Guided Early Optimization of ADAL in Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': "Therapeutic Drug Monitoring Guided Early Optimization of Adalimumab in Crohn's Disease; A Randomized Open Label Study", 'orgStudyIdInfo': {'id': 'MP-37-2017-2793'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard clinical care', 'description': "Adalimumab induction as per standard clinical care:\n\n* Week 0: 160 mg SC\n* Week 2: 80 mg SC\n* Followed by 40 mg SC every 2 weeks' maintenance therapy", 'interventionNames': ['Biological: Adalimumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active optimization', 'description': 'Same as Standard clinical care Arm, except:\n\n* If ADAL trough ≤15 μg/ml, dose escalation with 80 mg SC at week 6 followed by 40 mg SC every week\n* If ADAL trough \\>15 μg/ml, no dose escalation and continued standard of care dosing', 'interventionNames': ['Biological: Adalimumab']}], 'interventions': [{'name': 'Adalimumab', 'type': 'BIOLOGICAL', 'otherNames': ['Humira'], 'armGroupLabels': ['Active optimization', 'Standard clinical care']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4Z6', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary Medical Center (UCMC)', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'The University of British Columbia', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre (LHSC) University Hospital', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital, IBD Centre of Excellence', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Hospital Center (MUHC)', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'J1G 2E8', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Sherbrooke (CHUS)', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Waqqas Afif, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'waqqas.afif', 'class': 'OTHER'}, 'collaborators': [{'name': 'AbbVie', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr. Waqqas Afif MD, FRCPC', 'investigatorFullName': 'waqqas.afif', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}