A Study to Evaluate the Change in Disease State and Adverse Events in Adult Participants with Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment, Receiving Subcutaneous Injections of ABBV-154 (AIM-PMR)
Phase 2
Suspended
- Conditions
- Polymyalgia Rheumatica
- Registration Number
- JPRN-jRCT2031210315
- Lead Sponsor
- Yamazaki Hayato
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
Clinical diagnosis of Polymyalgia Rheumatica (PMR) and fulfillment of the 2012 European League Against
Rheumatism/American College of Rheumatology (EULAR/ACR) provisional classification criteria for PMR.
- Must have had at least 2 episodes of unequivocal PMR flare.
- Must be on a stable dose of prednisone.
- Must be willing to follow the protocol-defined glucocorticoid tapering regimen.
Exclusion Criteria
- Have been treated with a prior TNF antagonist.
- Current use of immunomodulators other than prednisone.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to Flare
- Secondary Outcome Measures
Name Time Method - Cumulative glucocorticoid dose by 24 weeks<br>- Achievement of flare-free state up to Week 24<br>- Change from Baseline in glucocorticoid dose at Week 24