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Sponsors and Collaborators: |
Genmab GlaxoSmithKline |
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Information provided by: | Genmab |
ClinicalTrials.gov Identifier: | NCT00603525 |
The purpose of this study is to determine the effect of ofatumumab combined with methotrexate in patients with rheumatoid arthritis who have responded inadequately to previous TNF-α inhibitor therapy
Condition | Intervention | Phase |
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Arthritis, Rheumatoid Rheumatoid Arthritis |
Drug: Ofatumumab Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
Official Title: | A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Multi-Center, Phase III Trial of Ofatumumab Investigating Clinical Efficacy in Adult Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to TNF-α Antagonist Therapy |
Estimated Enrollment: | 236 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Active: Experimental |
Drug: Ofatumumab
I.V. infusion, 2 x 700mg
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Placebo: Placebo Comparator |
Drug: Placebo
I.V. infusion 2 x placebo
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contact: Lesley Kahl | +44 (0) 208 422 3434 | Lesley.p.kahl@gsk.com |
Principal Investigator: | Ronald van Vollenhoven, MD, PhD | Karolinska Institute |
Study Director: | Hanne Storgaard Schultz, DVM | Genmab |
Responsible Party: | Genmab A/S ( Hanne Storgaard Schultz, International Clincial Trial Manager ) |
Study ID Numbers: | GEN411/OFA110634, IND12060, EudraCT number:2007-002951-18 |
Study First Received: | January 16, 2008 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00603525 |
Health Authority: | United States: Food and Drug Administration |
Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Immune System Diseases |