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Tests treatment safety and results for Polymyalgia Rheumatica
Official title Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica
ClinicalTrials.gov ID: NCT07286214
What this study is testing
What is Sarilumab?
Sarilumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for polymyalgia rheumatica.
Also referred to as Kevzara®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a randomized, double-blind, placebo-controlled, parallel-group, Phase 4, 3-group study to assess whether treatment with sarilumab at either 150 mg q2w (once every two weeks) or at 200 mg q2w, each given with a 52-week prednisone taper, is superior to placebo given with a 52-week prednisone taper in participants with early polymyalgia rheumatica (PMR) and to determine the safety and tolerability of the sarilumab regimens. The study will consist of the following visits: Visit 1 (D-42 to D-1): Screening, Visit 2 (D1): Baseline, randomization, first study drug administration, Visit 3 to 12 (Week 2 to Week 52): Treatment period, Visit 13 (Week 52): End of Treatment (EOT) visit, Visit 14 (Week 58): End of Study (EOS) visit.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
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...
- 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...
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...
- 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...
- 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 above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- Clearwater, Florida, United States
- Margate, Florida, United States
- Miami, Florida, United States
- Miramar, Florida, United States
- Plantation, Florida, United States
- Tampa, Florida, United States
- Willowbrook, Illinois, United States
- Santa Fe, New Mexico, United States
- Duncansville, Pennsylvania, United States
- Wyomissing, Pennsylvania, United States
- Jackson, Tennessee, United States
- Lufkin, Texas, United States
- Sherbrooke, Quebec, Canada
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, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States; Clearwater, Florida, United States; Margate, Florida, United States; Miami, Florida, United States; Miramar, Florida, United States; Plantation, Florida, United States and 8 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.