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)

JRCT ID: jRCT2031210315

Registered date:15/09/2021

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Polymyalgia Rheumatica
• Date of first enrollment: 18/10/2021
• Target sample size: 160
• Countries of recruitment: Australia,Japan,Austria,Japan,Canada,Japan,France,Japan,Germany,Japan,Hungary,Japan,Italy,Japan,Netherlands,Japan,New Zealand,Japan,Poland,Japan,South Korea,Japan,Spain,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): Participants will receive ABBV-154 (dose A, B or C) or placebo subcutaneously (SC) every other week (eow) for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.

Outcome(s)

• Primary Outcome: Time to Flare

Secondary Outcome

- Cumulative glucocorticoid dose by 24 weeks
- Achievement of flare-free state up to Week 24
- Change from Baseline in glucocorticoid dose at Week 24

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude criteria

- Have been treated with a prior TNF antagonist.
- Current use of immunomodulators other than prednisone.

Related Information

• Primary Sponsor: Yamazaki Hayato
• Secondary ID(s): NCT04972968