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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 50 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo 		Participants will receive placebo with prednisone taper
  • Drug: Placebo
    Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous
Experimental
Sarilumab 150 mg 		Participants will receive 150 mg sarilumab q2w with prednisone taper
  • Drug: Sarilumab
    Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous
    Other names:
    • Kevzara®
Experimental
Sarilumab 200 mg 		Participants will receive 200 mg sarilumab q2w with prednisone taper
  • Drug: Sarilumab
    Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous
    Other names:
    • Kevzara®

Recruiting Locations

Denver Arthritis Clinic - Lowry- Site Number : 8400001
Denver, Colorado 80230

Clinical Research of West Florida - Phase I Unit- Site Number : 8400024
Clearwater, Florida 33765

Vitalia Medical Research - Margate- Site Number : 8400021
Margate, Florida 33063

Innovia Research Center- Site Number : 8400029
Miramar, Florida 33027

Vantage Clinical Trials - Tampa- Site Number : 8400064
Tampa, Florida 33614

More Details

Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
Contact-US@sanofi.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.