Rheumatoid Arthritis Clinical Trial
Official title:
A Phase 4, Open-label, Repeat-Dose Study of the Safety and Pharmacodynamic Profile of Tocilizumab and Concomitant Methotrexate in Patients With Rheumatoid Arthritis
Verified date | October 2011 |
Source | Regeneron Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Regeneron Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety (clinical and laboratory parameters) | Proportion of patients with neutropenia, elevated transaminase, and/or decreased platelet count | Throughout the study until week 10 | Yes |
Secondary | Treatment emergent adverse events | Post-baseline changes in vital signs, and hematological and biochemical parameters | Throughout the study until week 10 | Yes |
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