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Sarilumab efficacy and safety in adults with early polymyalgia rheumatica
EU CTIS ID: 2024-511296-15-00
What this study is testing
To demonstrate the superiority in efficacy of sarilumab 200 mg q2w with a 52-week prednisone taper as compared to a 52-week prednisone taper in participants with early relapsing PMR
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adults >50 years with polymyalgia rheumatica according to the EULAR/ACR classification criteria
- Meet criteria for newly diagnosed PMR (received <6 weeks of corticosteroids prior to randomization) or for early relapsing PMR (initiated corticosteroid treatment within last year, treated with prednisone ≥10 mg/day for ≥ 8 weeks, and experienced flare within prior 12 weeks while receiving >5 mg/d prednisone)
- Participants must be willing and able to take prednisone of 15 mg/day at randomization
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
You likely can't join if
- Diagnosis of Giant Cell Arteritis (GCA)
- Concurrent rheumatoid arthritis, inflammatory arthritis, connective tissue diseases, fibromyalgia
- Inadequately treated hypothyroidism
- Exclusion related to tuberculosis (TB), invasive opportunistic infections, recurrent or persistent infections including hepatitis B, C or HIV, recurrent herpes zoster or active herpes zoster
- Patients with uncontrolled diabetes mellitus (HbA1c ≥9%
- Immunosuppressive therapies including systemic corticosteroids
See the full eligibility criteria
- Adults >50 years with polymyalgia rheumatica according to the EULAR/ACR classification criteria
- Meet criteria for newly diagnosed PMR (received <6 weeks of corticosteroids prior to randomization) or for early relapsing PMR (initiated corticosteroid treatment within last year, treated with prednisone ≥10 mg/day for ≥ 8 weeks, and experienced flare within prior 12 weeks while receiving >5 mg/d prednisone)
- Participants must be willing and able to take prednisone of 15 mg/day at randomization
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- Diagnosis of Giant Cell Arteritis (GCA)
- Concurrent rheumatoid arthritis, inflammatory arthritis, connective tissue diseases, fibromyalgia
- Inadequately treated hypothyroidism
- Exclusion related to tuberculosis (TB), invasive opportunistic infections, recurrent or persistent infections including hepatitis B, C or HIV, recurrent herpes zoster or active herpes zoster
- Patients with uncontrolled diabetes mellitus (HbA1c ≥9%
- Immunosuppressive therapies including systemic corticosteroids
- Malignancy
- Organ transplant recipient
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.