Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

Primary Objectives: Part A (dose ranging study): To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks. Part B (pivotal study): To demonstrate that sarilumab added to MTX was effective in: * reduction of signs and symptoms of rheumatoid arthritis at 24 weeks * inhibition of progression of structural damage at 52 weeks * improvement in physical function at 16 weeks Secondary Objectives: Part B: To demonstrate that sarilumab added to MTX was effective in induction of a major clinical response at 52 weeks To assess the safety of sarilumab added to MTX To document the pharmacokinetic profile of sarilumab added to MTX in participants with active rheumatoid arthritis who were inadequate responders to MTX therapy.

Key facts

Study ID

NCT01061736

Run by

Sanofi

People needed

1675

Starts

2010-03-01

Expected to finish

2013-10-01

Last updated by the study team

2017-06-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of rheumatoid arthritis ≥3 months duration
• Active disease defined as:
• at least 8/68 tender joints and 6/66 swollen joints,
• high sensitivity C-reactive protein (hs-CRP) >6 mg/l,
• continuous treatment with MTX for at least 12 weeks prior to baseline visit and on stable dose for at least 6 weeks prior to screening visit.
• Part B only:
• Bone erosion based on documented X-ray prior to first study drug intake, or
• Cyclic Citrullinated Peptide (CCP) positive, or
• Rheumatoid Factor (RF) positive.

You may not qualify if…

• Age <18 years or >75 years.
• Treatment with disease-modifying antirheumatic drugs (DMARDs) other than MTX within 4 weeks or 12 weeks prior to screening (depending on DMARDs).
• Past history of non-response to prior Tumor Necrosis Factor (TNF) or biologic treatment.
• Any past or current biologic agents for the treatment of rheumatoid arthritis within 3 months.
• Use of parenteral glucocorticoids or intraarticular glucocorticoids within 4 weeks prior to screening visit.
• Use of oral glucocorticoid greater than 10mg/day or equivalent/day, or a change in dosage within 4 weeks prior to baseline visit.
• 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 840004 — Birmingham, Alabama, United States
• Investigational Site Number 840072 — Gilbert, Arizona, United States
• Investigational Site Number 840029 — Beverly Hills, California, United States
• Investigational Site Number 840007 — Palm Desert, California, United States
• Investigational Site Number 840008 — San Francisco, California, United States
• Investigational Site Number 840021 — Santa Maria, California, United States
• Investigational Site Number 840049 — Upland, California, United States
• Investigational Site Number 840050 — Dunedin, Florida, United States
• Investigational Site Number 840041 — Jacksonville, Florida, United States
• Investigational Site Number 840067 — Jupiter, Florida, United States
• Investigational Site Number 840048 — Miami, Florida, United States
• Investigational Site Number 840006 — Orlando, Florida, United States
• Investigational Site Number 840063 — Palm Harbor, Florida, United States
• Investigational Site Number 840060 — Sarasota, Florida, United States
• Investigational Site Number 840003 — Atlanta, Georgia, United States
• Investigational Site Number 840028 — Decatur, Georgia, United States
• Investigational Site Number 840027 — Marietta, Georgia, United States
• Investigational Site Number 840018 — Idaho Falls, Idaho, United States
• Investigational Site Number 840046 — Chicago, Illinois, United States
• Investigational Site Number 840015 — Lexington, Kentucky, United States
• Investigational Site Number 840073 — Cumberland, Maryland, United States
• Investigational Site Number 840055 — Frederick, Maryland, United States
• Investigational Site Number 840013 — Wheaton, Maryland, United States
• Investigational Site Number 840066 — St Louis, Missouri, United States
• Investigational Site Number 840070 — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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