Status:
TERMINATED
Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to MTX Therapy
Lead Sponsor:
GlaxoSmithKline
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 demon...
Detailed Description
This study consists of a Double-blind , placebo controlled, and parallel group part with eligible patients enrolled into a 24 week Double-Blind Period, and randomized in a 1:1 ratio to receive ofatumu...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2013
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT00611455
Start Date
January 1 2008
End Date
July 15 2013
Last Update
November 6 2017
Active Locations (45)
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1
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1419AHN
2
GSK Investigational Site
Quilmes, Buenos Aires, Argentina, 1878
3
GSK Investigational Site
Rosario, Santa Fe Province, Argentina, 2000
4
GSK Investigational Site
Córdoba, Argentina, 5000