Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sarilumab, Sarilumab, Placebo.
- Who it may be relevant to
- Registry conditions: Polymyalgia Rheumatica. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Each of Two Dose Levels of Sarilumab in Adults With Early Polymyalgia Rheumatica
Overview
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.
Interventions
- Drug Sarilumab
Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous - Drug Sarilumab
Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous - Drug Placebo
Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous
Primary outcome measures
- Sustained remission at Week 52 (yes/no) in participants with early relapsing polymyalgia rheumatica (PMR) who received sarilumab 200 mg q2w with 52-week prednisone taper [Time frame: at Week 52]
Secondary outcome measures (9)
- Sustained remission at Week 52 (yes/no) in all participants (newly diagnosed PMR and early relapsing PMR) who received sarilumab 200 mg q2w with prednisone taper [Time frame: at Week 52]
- Sustained remission at Week 52 (yes/no) in participants with early relapsing PMR, as well as in all participants (newly diagnosed PMR and early relapsing PMR) who received sarilumab 150 mg q2w with prednisone taper [Time frame: at Week 52]
- Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), abnormalities in laboratory values, anti-drug antibody [Time frame: over the entire study period (up to Week 58)]
- Corticosteroid-free remission at Week 52 [Time frame: at Week 52]
- Remission at Week 24 [Time frame: at Week 24]
- Time in remission through Week 52 [Time frame: through Week 52]
- Incidence rate of flare through Week 52 [Time frame: through Week 52]
- Change from baseline in PMR activity score and its components at Weeks 24 and 52 [Time frame: at Weeks 24 and 52]
- Changes from baseline at Weeks 24 and 52 in the physical component summary and mental component summary from Short-form 36-item questionnaire (SF-36v2) [Time frame: at Weeks 24 and 52]
Eligibility criteria
Inclusion 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 13 centers
- Denver Arthritis Clinic - Lowry- Site Number : 8400001 — Denver
- Clinical Research of West Florida - Phase I Unit- Site Number : 8400024 — Clearwater
- Vitalia Medical Research - Margate- Site Number : 8400021 — Margate
- Florida Research Center- Site Number : 8400084 — Miami
- Innovia Research Center- Site Number : 8400029 — Miramar
- Discovery Clinical Research - Plantation- Site Number : 8400091 — Plantation
- Vantage Clinical Trials - Tampa- Site Number : 8400064 — Tampa
- Willow Rheumatology and Wellness- Site Number : 8400012 — Willowbrook
- … and 5 more centers
Canada · 1 center
- Investigational Site Number : 1240003 — Sherbrooke
Identifiers
NCT: NCT07286214 · EFC18055 · 2024-511296-15-00 · U1111-1310-5173