Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Sarilumab
  Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous
• Препарат Sarilumab
  Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous
• Препарат Placebo
  Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous

Первичные конечные точки

• 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 [Срок оценки: at Week 52]

Вторичные конечные точки (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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: over the entire study period (up to Week 58)]
• Corticosteroid-free remission at Week 52 [Срок оценки: at Week 52]
• Remission at Week 24 [Срок оценки: at Week 24]
• Time in remission through Week 52 [Срок оценки: through Week 52]
• Incidence rate of flare through Week 52 [Срок оценки: through Week 52]
• Change from baseline in PMR activity score and its components at Weeks 24 and 52 [Срок оценки: 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) [Срок оценки: at Weeks 24 and 52]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 13 центров

• 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
• … и ещё 5 центров

Канада · 1 центр

• Investigational Site Number : 1240003 — Sherbrooke

Идентификаторы

NCT: NCT07286214 · EFC18055 · 2024-511296-15-00 · U1111-1310-5173

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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