ABBV-154 for Polymyalgia Rheumatica

Leicester Royal Infirmary /ID# 231967, Leicester, United Kingdom
Polymyalgia RheumaticaABBV-154 - Drug
Eligibility
50 - 80
All Sexes
What conditions do you have?
Select

Study 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

Video Summary

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to Week 52

Up to Week 24
Percentage of Participants Achieving Flare-Free State
Up to Week 52
Time to Flare
Week 24
Change from Baseline in Glucocorticoid Dose
Cumulative Glucocorticoid Dose

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Trial Design

4 Treatment Groups

ABBV-154 Dose A
1 of 4
ABBV-154 Dose B
1 of 4
ABBV-154 Dose C
1 of 4
Placebo
1 of 4

Experimental Treatment

Non-Treatment Group

181 Total Participants · 4 Treatment Groups

Primary Treatment: ABBV-154 · Has Placebo Group · Phase 2

ABBV-154 Dose AExperimental Group · 2 Interventions: Glucocorticoid, ABBV-154 · Intervention Types: Drug, Drug
ABBV-154 Dose BExperimental Group · 2 Interventions: Glucocorticoid, ABBV-154 · Intervention Types: Drug, Drug
ABBV-154 Dose CExperimental Group · 2 Interventions: Glucocorticoid, ABBV-154 · Intervention Types: Drug, Drug
PlaceboPlaceboComparator Group · 2 Interventions: Glucocorticoid, Placebo · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glucocorticoid
2019
Completed Phase 2
~340

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to week 52

Who is running the clinical trial?

AbbVieLead Sponsor
871 Previous Clinical Trials
479,026 Total Patients Enrolled
1 Trials studying Polymyalgia Rheumatica
429 Patients Enrolled for Polymyalgia Rheumatica
ABBVIE INC.Study DirectorAbbVie
324 Previous Clinical Trials
124,263 Total Patients Enrolled
1 Trials studying Polymyalgia Rheumatica
429 Patients Enrolled for Polymyalgia Rheumatica

Eligibility Criteria

Age 50 - 80 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had at least 2 clear episodes of PMR flare.
You need to be taking a consistent amount of prednisone.

Who else is applying?

What state do they live in?
Illinois50.0%
California50.0%
How old are they?
65+100.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%
What site did they apply to?
Springfield Clinic /ID# 228840100.0%

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.