NL-OMON54200
Completed
Phase 2
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment - M20-370
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- PMR
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Enrollment
- 15
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adults at least 50 years of age with a clinical diagnosis of PMR and
- •fulfillment of the 2012 EULAR/ACR provisional classification criteria for PMR.
- •2\. Following a confirmed diagnosis of PMR, subject must have shown a clinical
- •response to prednisone (or equivalent).
- •3\. Subject must have had at least 2 episodes of unequivocal PMR flare while
- •attempting to taper prednisone, with the dose of prednisone (or equivalent) at
- •the time of flare \>\= 5 mg/day, prior to Baseline; the most recent flare must
- •have been within 24 weeks of Baseline. Unequivocal PMR flare is defined as
- •clinical signs and symptoms of PMR (shoulder and/or hip girdle pain with
- •inflammatory stiffness, neck pain with inflammatory stiffness, or new or
Exclusion Criteria
- •1\. Subject must have discontinued use of immunomodulators other than prednisone
- •(or equivalent) and hydroxychloroquine prior to Baseline.
- •2\. Subjects requiring \> 25 mg/day of prednisone to control confirmed PMR are
- •3\. Subject must not exhibit clinical signs and symptoms of PMR (shoulder and/or
- •hip girdle pain with inflammatory stiffness, neck pain with inflammatory
- •stiffness, or new or worsened limited range of motion of hips and/or shoulders)
- •within 2 weeks of Baseline
Outcomes
Primary Outcomes
Not specified
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