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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 300
- 试验地点
- 14
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Placebo
Participants will receive placebo with prednisone taper
干预措施: Placebo (Drug)
Sarilumab 150 mg
Participants will receive 150 mg sarilumab q2w with prednisone taper
干预措施: Sarilumab (Drug)
Sarilumab 200 mg
Participants will receive 200 mg sarilumab q2w with prednisone taper
干预措施: Sarilumab (Drug)
结局指标
主要结局
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
时间窗: at Week 52
No signs or symptoms of PMR at Week 24 and sustained through week 52 (without use of rescue therapy).
次要结局
- 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(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(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(over the entire study period (up to Week 58))
- Corticosteroid-free remission at Week 52(at Week 52)
- Remission at Week 24(at Week 24)
- Time in remission through Week 52(through Week 52)
- Incidence rate of flare through Week 52(through Week 52)
- Change from baseline in PMR activity score and its components at Weeks 24 and 52(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)(at Weeks 24 and 52)