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ABBV-154 for Polymyalgia Rheumatica (AIM-PMR Trial)

Phase 2
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 52
Awards & highlights

AIM-PMR Trial Summary

This trial will assess if ABBV-154 is a safe and effective treatment for PMR in adults aged 50 years or older.

Eligible Conditions
  • Polymyalgia Rheumatica

AIM-PMR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to Flare
Secondary outcome measures
Change from Baseline in Glucocorticoid Dose
Cumulative Glucocorticoid Dose
Percentage of Participants Achieving Flare-Free State

AIM-PMR Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: ABBV-154 Dose CExperimental Treatment2 Interventions
Participants in this group will receive dose C of ABBV-154 SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.
Group II: ABBV-154 Dose BExperimental Treatment2 Interventions
Participants in this group will receive dose B of ABBV-154 SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.
Group III: ABBV-154 Dose AExperimental Treatment2 Interventions
Participants in this group will receive dose A of ABBV-154 subcutaneously (SC) every other week (eow) for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.
Group IV: PlaceboPlacebo Group2 Interventions
Participants will receive placebo SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glucocorticoid
2019
Completed Phase 2
~340

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
954 Previous Clinical Trials
500,924 Total Patients Enrolled
1 Trials studying Polymyalgia Rheumatica
429 Patients Enrolled for Polymyalgia Rheumatica
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
145,758 Total Patients Enrolled
1 Trials studying Polymyalgia Rheumatica
429 Patients Enrolled for Polymyalgia Rheumatica

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate amount of participants in this research?

"This clinical trial necessitates 160 eligible patients. Patient enrollment locations include The Waterside Clinic /ID# 230364 in Barrie, Ontario and Rheumatology Care Center PLLC /ID# 232306 in Bellaire, Texas."

Answered by AI

Has the FDA granted authorization to ABBV-154?

"Our team has rated ABBV-154's safety as a 2 due to the lack of clinical evidence for its efficacy, though there is some data indicating it may be safe."

Answered by AI

Are there any areas in North America where this clinical trial is currently being implemented?

"The Waterside Clinic (ID# 230364) in Barrie, Ontario; Rheumatology Care Center PLLC (ID# 232306) in Bellaire, Texas; and St Jude Heritage Medical Group (ID# 228681) in Fullerton, California are among the 38 sites that have been enlisted to partake in this study."

Answered by AI

Are fresh participants being admitted to this trial presently?

"Affirmative. Data published on clinicaltrials.gov reveals that this medical trial, which started in September 9th 2021 is actively recruiting patients. Approximately 160 participants must be enrolled from 35 different sites."

Answered by AI

Is enrollment open to geriatric individuals for this investigation?

"Elderly individuals aged between 50 and 80 years old have the opportunity to be enrolled in this scientific research."

Answered by AI

What criteria must one fulfill to be eligible for enrollment in this experiment?

"This clinical trial is seeking 160 individuals with a diagnosis of Polymyalgia Rheumatica, aged between 50 and 80. Principal eligibility requirements include: conforming to the 2012 EULAR/ACR provisional classification criteria for PMR; having experienced two unequivocal episodes of PMR flare-up; being on a consistent dose of prednisone; and adhering to the protocol's tapering regimen concerning glucocorticoids."

Answered by AI

Who else is applying?

What state do they live in?
California
Illinois
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Springfield Clinic /ID# 228840
Recent research and studies
clinicaltrials.govStudy
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
2021. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04972968.
~51 spots leftby Apr 2025
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