To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

Primary Objective: To assess, in the same study, the safety of sarilumab and tocilizumab in participants with rheumatoid arthritis (RA) who were inadequate responders to or intolerant of tumor necrosis factor (TNF) antagonists.

Key facts

Study ID

NCT01768572

Run by

Sanofi

People needed

202

Starts

2013-03-01

Expected to finish

2014-10-01

Last updated by the study team

2017-06-26

Who can join

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

You may qualify if…

• Diagnosis of RA was, according to the American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) 2010 Rheumatoid Arthritis Classification Criteria with ≥ 3 months disease duration
• ACR Class I-III functional status, was based on the 1991 revised criteria. Moderate-to-severely active RA. Anti-TNF therapy failures, was defined as participants with an inadequate clinical response was defined by the investigator, after being treated for at least 3 consecutive months, and/or intolerance to at least 1 TNF-antagonist, resulting in or requiring their discontinuation. TNF-antagonists were include, but were not limited to, etanercept, infliximab, adalimumab, golimumab and/or certolizumab pegol
• Continuous treatment with one or a combination of non-biologic disease modifying antirheumatic drugs (DMARDs) for at least 12 consecutive weeks prior to screening and on a stable dose(s) for at least 6 consecutive weeks prior to screening:
• Methotrexate - 10 to 25 milligram/week orally or parenteral (or per local labelling requirements if the dose range differs)
• Leflunomide - 10 to 20 mg orally daily
• Sulfasalazine (SSZ) - 1000 to 3000 mg orally daily
• Hydroxychloroquine (HCQ) - 200 to 400 mg orally daily

You may not qualify if…

• Participants <18 years of age. Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks prior to screening
• Use of oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per day, or a change in dosage within 4 weeks prior to screening
• 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 systemic RA, including but not limited to vasculitis, pulmonary fibrosis, and/or Felty's syndrome
• Participation in any clinical research study that evaluated an investigational drug or therapy within 5 half-lives or 60 days of the Screening Visit, whichever was longer
• Participants with active tuberculosis or latent tuberculosis infection. Prior or current history of interstitial lung disease. Prior treatment with anti-interleukin (IL) -6 or anti-IL-6R therapies, including but not limited to tocilizumab or sarilumab
• Treatment with anti-TNF agents, as follows:
• Etanercept: within 28 days prior to randomization
• Infliximab, adalimumab, golimumab, certolizumab pegol: within 42 days prior to randomization
• Treatment with RA-directed biologic agents with non- TNF-α antagonist mechanisms without adequate washout as follows:
• Anakinra: within 28 days prior to randomization
• Abatacept: within 42 days prior to randomization
• Rituximab or other cell depleting agent: Within 6 months prior to randomization or until total lymphocyte count and CD 19+ lymphocyte count were normalized, or whichever was longer
• Prior treatment with a janus kinase (JAK) inhibitor (eg, tofacitinib). Participants with a history of invasive opportunistic infection. Prior or current history of malignancy, including lymphoproliferative diseases, other than adequately-treated carcinoma in-situ of the cervix, nonmetastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the randomization (baseline) visit
• Prior or current history of other significant concomitant illness(es) that, according to Investigator's judgement, was adversely affect the participant's participation in the study.
• The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 840151 — Colorado Springs, Colorado, United States
• Investigational Site Number 840153 — Aventura, Florida, United States
• Investigational Site Number 840033 — Fort Lauderdale, Florida, United States
• Investigational Site Number 840048 — Miami, Florida, United States
• Investigational Site Number 840155 — Palm Harbor, Florida, United States
• Investigational Site Number 840013 — Wheaton, Maryland, United States
• Investigational Site Number 840154 — Boston, Massachusetts, United States
• Investigational Site Number 840150 — Lansing, Michigan, United States
• Investigational Site Number 840062 — Reading, Pennsylvania, United States
• Investigational Site Number 840038 — Austin, Texas, United States
• Investigational Site Number 840022 — Dallas, Texas, United States
• Investigational Site Number 840156 — Dallas, Texas, United States
• Investigational Site Number 840074 — Mesquite, Texas, United States
• Investigational Site Number 032006 — Caba, Argentina
• Investigational Site Number 032010 — Ramos Mejía, Argentina
• Investigational Site Number 032013 — Rosario, Argentina
• Investigational Site Number 032015 — San Fernando, Argentina
• Investigational Site Number 032004 — San Miguel de Tucumán, Argentina
• Investigational Site Number 032005 — San Miguel de Tucumán, Argentina
• Investigational Site Number 056010 — Leuven, Belgium
• Investigational Site Number 076001 — Curitiba, Brazil
• Investigational Site Number 076030 — São José do Rio Preto, Brazil
• Investigational Site Number 203009 — Liberec, Czechia
• Investigational Site Number 203011 — Prague, Czechia
• Investigational Site Number 840152 — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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