Study of Tocilizumab to Treat Polymyalgia Rheumatica
Part of paid clinical trials in New York, New York.
- Sponsor
- Hospital for Special Surgery, New York
- Study ID
- NCT01396317
- Phase
- PHASE2
- Status
- Completed
Conditions
- Polymyalgia Rheumatica (PMR)
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Tocilizumab — DRUGTocilizumab is a humanized anti-interleukin-6 receptor antibody that has been FDA approved for the treatment of rheumatoid arthritis (RA). This molecule binds to the IL-6 binding site of human IL-6 receptor, and competitively inhibits IL-6 signaling.
Study Details
This is a fifteen-month open label, Phase IIa clinical trial is being conducted to assess the tolerability, safety and efficacy of a medication called Tocilizumab (Actemra®) in patients with polymyalgia rheumatica (PMR).
Key Dates
- Start date
- Apr 30, 2011
- Status verified
- Jan 2018
- Primary completion
- Dec 31, 2015
- Completion
- Jan 31, 2016
Study Design
- Enrollment
- 10 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: TocilizumabThis is a single-arm study. All subjects will receive the active study treatment for 12 months, and will then be evaluated for 3 months of long-term follow-up.
Primary Outcome Measure
Proportion of Patients in Disease Remission at Six Months From Trial Entry [ Time Frame: Six months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 100214898 | - |
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