Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-α Blockers

Part of paid clinical trials in Freehold, New Jersey.

Sponsor
Sanofi
Study ID
NCT01217814
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Sarilumab — DRUG
    Pharmaceutical form: solution for injection Route of administration: subcutaneous
  • Placebo — DRUG
    Pharmaceutical form: solution for injection Route of administration: subcutaneous
  • Golimumab — DRUG
    Pharmaceutical form: solution for injection Route of administration: subcutaneous
  • methotrexate (MTX) — DRUG
    Pharmaceutical form: tablet or solution for injection Route of administration: Oral (tablet) or subcutaneous, intramuscular (solution)
  • Folic/folinic acid — DRUG
    Pharmaceutical form: tablet Route of administration: oral Folic/folinic acid continued according to local standard.

Study Details

Primary Objective: \- To demonstrate that sarilumab (SAR153191/REGN88) on top of methotrexate (MTX) was superior in efficacy to placebo for the relief of signs and symptoms of rheumatoid arthritis (RA), in participants with active RA who had failed up to 2 tumor necrosis factor-alpha (TNF-α) antagonists. Secondary Objectives: * To assess the safety of sarilumab; * To document the pharmacokinetic profile of sarilumab.

Key Dates

Start date
Nov 30, 2010
Status verified
Jul 2017
Primary completion
Sep 30, 2011
Completion
Sep 30, 2011

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Placebo 2 mL to match sarilumab once a week (qw) and 0.5 mL to match golimumab every 4 weeks (q4w) on top of MTX (15-25 mg) qw for 12 weeks.
  • Active Comparator: Golimumab 50 mg
    Golimumab 50 mg q4w and placebo (matched to sarilumab) qw on top of MTX (15-25 mg) qw for 12 weeks.
  • Experimental: Sarilumab 150 mg
    Sarilumab 150 mg qw and placebo (matched to golimumab) q4w on top of MTX (15-25 mg) qw for 12 weeks.

Primary Outcome Measure

Percentage of Participants Who Achieved at Least 20% Improvement in American College of Rheumatology (ACR20) Core Set Disease Activity Index at Week 12 [ Time Frame: Week 12 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Investigational Site Number 840026FreeholdNew Jersey07728-
Investigational Site Number 840043New YorkNew York11201-
Investigational Site Number 840025JacksonTennessee38305-
Investigational Site Number 840038AustinTexas78705-

Find similar trials in Freehold, NJ

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Investigational· Freehold, NJInvestigational· New York, NYInvestigational· Jackson, TNInvestigational· Austin, TX

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