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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00686868 |
This study will examine the safety and tolerability, PK and PD of subcutaneous administered GSK1841157 in patients with RA on stable dose Methotrexate. Part A consists of a single dose escalation/deescalation phase to investigate the minimal efficacious dose based on PD markers with an acceptable safety profile. Part B will include 2 doses selected from Part A with re-dosing being performed at a fixed interval.
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: Ofatumumab (GSK1841157) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Clinical Phase I/IIA Study of Subcutaneous Administration of Ofatumumab in Rheumatoid Arthritis Patients on Stable Dose Methotrexate |
Estimated Enrollment: | 70 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
5.2.2. Additional Inclusion Criteria for subjects in Part B
• Active disease at the time of screening and baseline with a DAS28 score ≥3.2 (based on ESR) despite stable dose of methotrexate (MTX), 7.5-25mg/week.
Exclusion Criteria:
Received any of the following treatments within 4 weeks prior to Visit 2:
Past or current malignancy, except for:
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.
Screening laboratory values (according to central laboratory):
Positive serology for hepatitis B (HB) defined as:
o Positive test for HBsAg.
If negative, Hep B serology negativity will be confirmed by:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | OFA110867 |
Study First Received: | May 28, 2008 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00686868 |
Health Authority: | Australia: Therapeutic Goods Administration; United States: Food and Drug Administration |
GSK1841157; rheumatoid arthritis, anti-CD20 monoclonal antibody, B-cell depletion |
Antibodies, Monoclonal Antibodies Autoimmune Diseases Musculoskeletal Diseases Rituximab Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Methotrexate Rheumatic Diseases Immunoglobulins |
Immune System Diseases |