A Study of Tocilizumab in Patients With Rheumatoid Arthritis

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01187563
• Lead Sponsor: Regeneron Pharmaceuticals

Brief Summary

This is an open-label, uncontrolled, observational study in patients with rheumatoid arthritis (RA) who are receiving tocilizumab concomitantly with methotrexate as part of their standard of care.

Detailed Description

This single arm, open label study evaluates the safety and pharmacodynamic profile of tocilizumab in RA patients. Participating patients are among those for whom tocilizumab is indicated and who are scheduled to receive tocilizumab as part of their normal care, in full compliance with the FDA-approved prescribing information. Study assessments consist of clinical evaluations and laboratory tests conducted in conjunction with the first three monthly intravenous infusions of tocilizumab. These assessments are designed to provide a better understanding of the pharmacodynamic effects and mechanistic actions of tocilizumab and help guide the clinical development of other therapeutic agents for RA. A total of 15 patients are expected to participate for approximately 10 weeks.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-23
• Study First Submitted QC: 2010-08-23
• Study First Posted: 2010-08-24
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-12
• Last Update Posted: 2011-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• ≥ 18 years of age
• Moderately to severely active rheumatoid arthritis
• Inadequate response to previous treatment with an anti-TNF agent
• Receiving methotrexate for at least 12 wks before study

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Exclusion Criteria

• Previous treatment with tocilizumab
• Previous treatment with other IL-6 receptor inhibitors
• Treatment with corticosteroids (oral prednisone >10 mg/day or equivalent) within 4 wks
• Conditions noted in the tocilizumab prescribing information

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety (clinical and laboratory parameters)	Throughout the study until week 10	Proportion of patients with neutropenia, elevated transaminase, and/or decreased platelet count

Secondary Outcome Measures

Name	Time	Method
Treatment emergent adverse events	Throughout the study until week 10	Post-baseline changes in vital signs, and hematological and biochemical parameters