Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT00848692
Status:
COMPLETED
Last Update Posted:
2021-05-11
First Post:
2009-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Intervention in Chronic Fatigue Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015673', 'term': 'Fatigue Syndrome, Chronic'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D004679', 'term': 'Encephalomyelitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'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'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-10', 'studyFirstSubmitDate': '2009-02-19', 'studyFirstSubmitQcDate': '2009-02-19', 'lastUpdatePostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.', 'timeFrame': '3 months after intervention'}], 'secondaryOutcomes': [{'measure': 'Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes', 'timeFrame': '2, 4, 6, 8, 10, 12 months after intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Fatigue Syndrome', 'CFS', 'Myalgic Encephalomyelitis', 'Rituximab', 'B-lymphocyte depletion', 'B-cell depletion'], 'conditions': ['Chronic Fatigue Syndrome']}, 'referencesModule': {'references': [{'pmid': '22039471', 'type': 'DERIVED', 'citation': 'Fluge O, Bruland O, Risa K, Storstein A, Kristoffersen EK, Sapkota D, Naess H, Dahl O, Nyland H, Mella O. Benefit from B-lymphocyte depletion using the anti-CD20 antibody rituximab in chronic fatigue syndrome. A double-blind and placebo-controlled study. PLoS One. 2011;6(10):e26358. doi: 10.1371/journal.pone.0026358. Epub 2011 Oct 19.'}]}, 'descriptionModule': {'briefSummary': 'Based on pilot patient observations,the investigators anticipate that chronic fatigue syndrome (CFS) patients may benefit from B-cell depletion therapy.\n\nThe hypothesis is that at least a subset of CFS patients have an activated immune system involving B-lymphocytes, and that B-cell depletion may alleviate symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* verified chronic fatigue syndrome (CDC-criteria)\n* age \\>18 and \\<60 years\n* informed consent\n\nExclusion Criteria:\n\n* pregnancy or lactation\n* previous malignant disease except basal cell carcinoma of skin and cervical carcinoma in situ\n* previous long-term use of immunosuppressive drugs\n* previous exposure to rituximab\n* endogenous depression\n* multi-allergy with risk of serious drug reaction\n* reduced renal function (creatinin \\> 1.2 x UNL)\n* reduced liver function (bilirubin or transaminases \\> 1.5 x UNL)\n* known HIV infection\n* signs of active viral infection by pretreatment investigations'}, 'identificationModule': {'nctId': 'NCT00848692', 'acronym': 'KTS-1-2008', 'briefTitle': 'Drug Intervention in Chronic Fatigue Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': 'B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. A Double-blind, Placebo-controlled Study.', 'orgStudyIdInfo': {'id': '18257'}, 'secondaryIdInfos': [{'id': 'EudraCT: 2007-007973-22'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Rituximab', 'interventionNames': ['Drug: Rituximab']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo (saline)', 'interventionNames': ['Drug: Saline (NaCl 0,9 %) (placebo)']}], 'interventions': [{'name': 'Rituximab', 'type': 'DRUG', 'description': 'Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart', 'armGroupLabels': ['1']}, {'name': 'Saline (NaCl 0,9 %) (placebo)', 'type': 'DRUG', 'description': 'Two infusions of saline (NaCl 0,9 %) given two weeks apart', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N-5021', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Department of Oncology and Medical Physics, Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'overallOfficials': [{'name': 'Olav Mella, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Oncology and Medical Physics, Haukeland University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}