Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-01-04 @ 1:09 PM
Study NCT ID:
NCT00686868
Status:
COMPLETED
Last Update Posted:
2017-06-26
First Post:
2008-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate SC Route of Administration of Ofatumumab in RA Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'Germany', 'Hungary', 'Netherlands']}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C527517', 'term': 'ofatumumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2011-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-23', 'studyFirstSubmitDate': '2008-05-28', 'studyFirstSubmitQcDate': '2008-05-28', 'lastUpdatePostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability as described by the incidence and severity of adverse events [AEs], clinical laboratory parameters and vital signs.', 'timeFrame': 'throughout the study'}], 'secondaryOutcomes': [{'measure': 'Requirement for the use of pre-medication, including the timing, type and dose required.', 'timeFrame': 'throughout study'}, {'measure': 'Pharmacodynamics (B-cell depletion and re-population) as measured by CD-19 peripheral blood B- lymphocyte count via routine fluorescent activated cell sorting (FACS) analysis.', 'timeFrame': 'throughout study'}, {'measure': 'PK/PD parameters including estimation of time to re-population of CD-19 peripheral blood B-cells to above LLQ (and/or <95% depletion) following single subcutaneous dose of Ofatumumab.', 'timeFrame': 'throughout study'}, {'measure': 'Immunogenicity as measured by the incidence, titre and type of human anti-human antibody (HAHA) immune response.', 'timeFrame': 'throughout study'}, {'measure': 'Other pharmacodynamic/biomarkers of disease activity and immune status may include high sensitivity C-reactive protein (hsCRP), Erythrocyte Sedimentation Rate (ESR), B-Lymphocyte Stimulator (BLyS/BAFF), B-Lymphocyte Chemokine (BLC), IL-6,', 'timeFrame': 'throughout study'}, {'measure': 'Immunoglobulins (IgA, IgG, IgM), Complement (CH50, C3, C4), IgM Rheumatoid Factor (IgM-RF), IgA-RF and IgG-RF, anti-cyclic citrullinated peptide antibody (aCCP),', 'timeFrame': 'throughout study'}, {'measure': 'serum amyloid A (SAA), CD-3+, CD-4+ and CD-8+ lymphocytes or other biomarkers, as data permit.', 'timeFrame': 'throughout study'}, {'measure': 'Pharmacodynamics (B-cell depletion and re-population) as measured by CD-19 peripheral blood B- lymphocyte count via routine FACS analysis.Other Secondary Endpoints', 'timeFrame': 'throughout study'}]}, 'conditionsModule': {'keywords': ['GSK1841157;', 'rheumatoid arthritis,', 'B-cell depletion', 'anti-CD20 monoclonal antibody,'], 'conditions': ['Arthritis, Rheumatoid']}, 'referencesModule': {'references': [{'pmid': '23729801', 'type': 'DERIVED', 'citation': 'Kurrasch R, Brown JC, Chu M, Craigen J, Overend P, Patel B, Wolfe S, Chang DJ. Subcutaneously administered ofatumumab in rheumatoid arthritis: a phase I/II study of safety, tolerability, pharmacokinetics, and pharmacodynamics. J Rheumatol. 2013 Jul;40(7):1089-96. doi: 10.3899/jrheum.121118. Epub 2013 Jun 1.'}], 'seeAlsoLinks': [{'url': 'https://www.gsk-clinicalstudyregister.com/study/OFA110867?search=study&search_terms=OFA110867#rs', 'label': 'Results for study OFA110867 can be found on the GSK Clinical Study Register.'}]}, 'descriptionModule': {'briefSummary': 'This study will examine the safety and tolerability, PK and PD of subcutaneously administered GSK1841157 in patients with RA on stable dose Methotrexate. The study comprises a single dose escalation/de-escalation phase to investigate the minimal efficacious dose based on PD markers with an acceptable safety profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Male or female aged ≥ 18 years\n* A diagnosis of rheumatoid arthritis according to the American College of Rheumatology (ACR1987 classification) of at least six months prior to screening\n* Subjects must be treated with MTX, 7.5-25 mg/week, for at least 12 weeks prior to Visit 2, with the last 4 weeks prior to Day 2 at a stable dosage\n* Patient must be willing to receive folic acid ≥5mg/wk 4 weeks prior to baseline administered according to locally accepted practice\n* Body mass index (BMI) \\< 35kg/m2 (inclusive)\n* Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form\n\nKey Exclusion Criteria:\n\n* Subjects with a history of a rheumatic autoimmune disease other than RA (except secondary Sjögren's syndrome), or with significant systemic involvement secondary to RA (vasculitis, pulmonary fibrosis or Felty's syndrome)\n* Previous exposure to biologic cell depleting anti-rheumatic therapies, including investigational compounds (e.g. anti-CD11a, anti-CD19, anti-CD20, anti-CD22, anti-BLyS/BAFF, anti-CD3, anti-CD4, anti-CD5, anti-CD52)\n* Exposure to etanercept \\< 4 weeks, infliximab or adalimumab \\< 8 weeks, or abatacept or anakinra \\< 12 weeks prior to visit 2\n* Received any of the following treatments within 4 weeks prior to Visit 2:\n* Anti-cancer therapy (e.g. alkylating agents, anti-metabolites, purine analogues, monoclonal antibodies)\n* Glucocorticoid unless given in doses equivalent to ≤ 10 mg of prednisolone /day\n* Intra-articular, i.m. or IV corticosteroids\n* Live/attenuated vaccinations\n* Cyclosporine\n* Azathioprine\n* Penicillamine\n* Sulfasalazine\n* Bucillamine\n* Hydroxychloroquine\n* Chloroquine\n* Exposure to leflunomide within 12 weeks prior to visit 2 unless the subject has completed peroral cholestyramine treatment\n* Exposure to gold therapy ≤ 12 weeks prior to Visit 2\n* Exposure to IV immunogammaglobulins ≤ 24 weeks prior to Visit 2\n* Past or current malignant melanoma\n* Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, renal infection, chest infection with bronchiectasis, tuberculosis and active hepatitis B and C\n* History of significant cerebrovascular disease\n* Positive plasma / white cell JC Virus (JCV) PCR (either compartment)"}, 'identificationModule': {'nctId': 'NCT00686868', 'briefTitle': 'Study to Evaluate SC Route of Administration of Ofatumumab in RA Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Clinical Phase I/IIA Study of Subcutaneously Administration of Ofatumumab in Rheumatoid Arthritis Patients on Stable Dose Methotrexate', 'orgStudyIdInfo': {'id': 'OFA110867'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '30mg', 'description': 'active', 'interventionNames': ['Drug: ofatumumab']}, {'type': 'EXPERIMENTAL', 'label': '3mg', 'description': 'active', 'interventionNames': ['Drug: ofatumumab']}, {'type': 'EXPERIMENTAL', 'label': '0.3mg', 'description': 'active', 'interventionNames': ['Drug: ofatumumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo', 'interventionNames': ['Other: placebo']}, {'type': 'EXPERIMENTAL', 'label': '60mg', 'description': '60mg', 'interventionNames': ['Drug: ofatumumab']}, {'type': 'EXPERIMENTAL', 'label': '100mg', 'description': '100mg', 'interventionNames': ['Drug: ofatumumab']}], 'interventions': [{'name': 'placebo', 'type': 'OTHER', 'description': 'placebo', 'armGroupLabels': ['placebo']}, {'name': 'ofatumumab', 'type': 'DRUG', 'description': 'fully human 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{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}