Phase 2
N=20
Study of Tocilizumab to Treat Polymyalgia Rheumatica
Polymyalgia Rheumatica (PMR)
Bottom Line
View on ClinicalTrials.gov: NCT01396317 ↗Enrolled (actual)
20
Serious AEs
10.0%
Results posted
Jan 2018
Primary outcome: Primary: Proportion of Patients in Disease Remission at Six Months From Trial Entry — 9; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tocilizumab (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients in Disease Remission at Six Months From Trial Entry |
9; 0 | — |
| PRIMARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
23; 1 | — |
| SECONDARY Proportion of Patients Able to Achieve Disease Remission (DR) Off Corticosteroids, Without Disease Relapse or Recurrence |
9; 0 | — |
| SECONDARY Proportion of Patients Who Develop Disease Relapses |
0; 10 | — |
| SECONDARY The Cumulative Dose of Prednisone |
1,085.3; 2562.0 | — |
| SECONDARY Total Number of Relapses/Recurrences |
0; 7 | — |
Summary
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).
Eligibility Criteria
Disease- Specific Inclusion Criteria:
Patients must meet the following inclusion criteria to be eligible for study entry:
Diagnosed with polymyalgia rheumatica and enrolled within one month of diagnosis.
Disease Specific Exclusion Criteria:
Patients will be excluded from the study based on the following criteria:
- Symptoms or diagnosis of temporal arteritis, including headache, jaw claudication, hyperesthesia of scalp, abnormal palpated temporal artery, visual disturbances, temporal artery biopsy positivity
- Concurrent rheumatoid arthritis
- Presence of rheumatoid factor and CCP
- Other inflammatory arthritis or other connective tissue diseases, such as but not limited to systemic lupus erythematosus, systemic sclerosis, vasculitis, polymyositis, dermatomyositis, mixed connective tissue disease
- Treatment of polymyalgia rheumatica with more than 20mg of daily prednisone or its equivalent at the time of screening
- Treatment with more than 30mg of daily prednisone or its equivalent since diagnosis. Treatment with 30mg of daily prednisone or its equivalent since diagnosis for more than 2 weeks.
- More than 4 weeks of corticosteroid therapy prior to enrollment
- History of bowel perforation within the past five years.
- Active diverticulitis.
- Pre-existing or recent onset demyelinating disorders
Data sourced from ClinicalTrials.gov (NCT01396317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.