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

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Folic Acid; Methotrexate

Criteria

Inclusion criteria :

• 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.

Exclusion criteria:

• 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.