To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA)

Completed · Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

Primary Objective: To evaluate the immunogenicity of sarilumab administered as monotherapy. Secondary Objectives: * To evaluate the other safety aspects of sarilumab administered as monotherapy. * To assess the exposure of sarilumab administered as monotherapy.

Key facts

Study ID

NCT02121210

Run by

Sanofi

People needed

132

Starts

2014-06-01

Expected to finish

2015-05-01

Last updated by the study team

2017-06-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of rheumatoid arthritis (RA) ≥ 3 months.
• Moderately to severely active rheumatoid arthritis.
• Participants who per investigator judgment were incomplete responders to at least 12 weeks of an adequate dose of continuous treatment with or who were intolerant of one or a combination of non-biologic disease modifying anti-rheumatic drugs (DMARDs).

You may not qualify if…

• Participants < 18 years of age.
• Past history of, or current, autoimmune or inflammatory systemic or localized joint disease(s) other than RA.
• History of juvenile idiopathic arthritis or arthritis onset prior to age 16.
• Severe active systemic RA, including but not limited to vasculitis, pulmonary fibrosis, and/or Felty's syndrome.
• Prior treatment with any biologic anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonist therapies.
• Treatment with prednisone > 10 mg or equivalent per day, or change in dosage within 4 weeks prior to randomization.
• New treatment with or dose-adjustment of on-going nonsteroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors within 4 weeks prior to randomization, except for the use of low-dose acetylsalicylic acid for cardiovascular diseases.
• Use of parenteral glucocorticoids or intra-articular glucocorticoids injection within 4 weeks prior to randomization.
• Prior treatment with a Janus kinase (JAK) inhibitor (tofacitinib).
• New treatment or dose-adjustment to on-going medication for dyslipidemia, such as statin, within 6 weeks prior to randomization.
• Participation in any clinical research study evaluating another investigational drug or therapy within 5 half-lives or 60 days of first dose of study drug administration, whichever is longer.
• Participants with a history of malignancy other than adequately-treated carcinoma in-situ of the cervix, non-metastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the randomization visit. Non-malignant lymphoproliferative disorders are also excluded.
• Participants with active tuberculosis or untreated latent tuberculosis infection.
• Pregnant or breast feeding women.
• The above information is not intended to contain all considerations relevant to a Participant's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 840072 — Gilbert, Arizona, United States
• Investigational Site Number 840049 — Upland, California, United States
• Investigational Site Number 840220 — South Miami, Florida, United States
• Investigational Site Number 840230 — Elizabethtown, Kentucky, United States
• Investigational Site Number 840233 — Minot, North Dakota, United States
• Investigational Site Number 840127 — Oklahoma City, Oklahoma, United States
• Investigational Site Number 840011 — Tulsa, Oklahoma, United States
• Investigational Site Number 840009 — Duncansville, Pennsylvania, United States
• Investigational Site Number 840025 — Jackson, Tennessee, United States
• Investigational Site Number 840032 — Amarillo, Texas, United States
• Investigational Site Number 840074 — Mesquite, Texas, United States
• Investigational Site Number 840124 — Clarksburg, West Virginia, United States
• Investigational Site Number 840231 — Franklin, Wisconsin, United States
• Investigational Site Number 152002 — Santiago, Chile
• Investigational Site Number 203034 — Pardubice, Czechia
• Investigational Site Number 203001 — Prague, Czechia
• Investigational Site Number 203002 — Uherské Hradiště, Czechia
• Investigational Site Number 233010 — Tallinn, Estonia
• Investigational Site Number 233002 — Tallinn, Estonia
• Investigational Site Number 348014 — Budapest, Hungary
• Investigational Site Number 348025 — Budapest, Hungary
• Investigational Site Number 348021 — Esztergom, Hungary
• Investigational Site Number 616018 — Poznan, Poland
• Investigational Site Number 616031 — Warsaw, Poland
• Investigational Site Number 616012 — Wroclaw, Poland

Full record on ClinicalTrials.gov

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