Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to MTX Therapy

• Status: Terminated
• Trial end date: 2013-07-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase III, double-blind, randomized, multicenter, and parallel group trial with a duration of 24 weeks, followed by a 120 week Open-label Period. the primary purpose of the study is to demonstrate the efficacy of ofatumumab in reducing clinical signs and symptoms in adult RA patients after a single course of ofatumumab.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Antibodies, Monoclonal; Ofatumumab

Criteria

Inclusion Criteria

• Age ≥ 18 years;

• Active disease at the time of screening as defined by:

≥ 8 swollen joints (of 66 joints assessed) and ≥ 8 tender joints (of 68 joints assessed), C-Reactive Protein (CRP) ≥ 1.0 mg/dL or Erythrocyte Sedimentation Rate (ESR) ≥ 22 mm/hour, DAS28≥3.2 (based on ESR);

• Inadequate response to previous or current methotrexate treatment;

• Treatment with methotrexate (MTX), 7.5-25 mg/week, for at least 12 weeks and at a stable dose for at least 4 weeks.

Exclusion Criteria

• Patients with a history of a rheumatic autoimmune disease other than RA or with significant systemic involvement secondary to RA;

• Previous exposure to biologic anti-rheumatic therapies, including investigational compounds;

• Previous exposure to biologic DMARDs; Chronic or ongoing active infectious disease requiring systemic treatment;

• Clinically significant cardiac disease; History of significant cerebrovascular disease;

• Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral psychiatric disease, or evidence of demyelinating disease;

• Known HIV positive; Serologic evidence of Hepatitis B infection; Positive test for Hepatitis C; Positive plasma / white cell JC Virus PCR;

• Serum IgG < lower limit of normal;

• Breast feeding women or women with a positive pregnancy test at screening;

• Current participation in any other interventional clinical study;

• Patients known or suspected of not being able to comply with a study protocol.