AIM-PMR

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

Brief summary

Polymyalgia rheumatica (PMR) is an inflammatory disease causing shoulder, hip, and neck pain and stiffness, in adults aged 50 years or older. This study evaluates how safe and effective ABBV-154 is in participants with glucocorticoid-dependent PMR. Adverse events and change in disease activity will be assessed. ABBV-154 is an investigational drug being evaluated for the treatment of PMR. Participants will be randomized into 1 of 4 treatment groups or arms, each arm receiving a different treatment. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 160 participants, of at least 50 years of age, with PMR will be enrolled in the study at approximately 95 sites worldwide. The study is compromised of a 52 week double-blind, placebo-controlled period and a follow-up visit 70 days after the last dose of the study drug. All participants will receive a glucocorticoid taper along with the assigned dose of ABBV-154 or placebo, subcutaneously (SC) every other week (eow). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Interventional study

Status:
Terminated
Conditions:
Polymyalgia Rheumatica
Enrollment:
181 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M20-370
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Purpose:
Treatment

Would you like to know more about this trial?

alert image Please note, participation in the clinical trial is open to patients with the disease or condition under investigation.
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Eligibility criteria

Participant attributes:
Male and Female

Age:

50 Years and older.

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 and hydroxychloroquine.

All the cities where the clinical studies are located

Edmonton - T5M 0H4
Barrie - L4M 6L2
Rimouski - G5L 5T1
Trois-rivières - G8Z 1Y2