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

NCT01217814 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-09-01

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Sarilumab

Pharmaceutical form: solution for injection Route of administration: subcutaneous

DRUG

Placebo

Pharmaceutical form: solution for injection Route of administration: subcutaneous

DRUG

Golimumab

Pharmaceutical form: solution for injection Route of administration: subcutaneous

DRUG

methotrexate (MTX)

Pharmaceutical form: tablet or solution for injection Route of administration: Oral (tablet) or subcutaneous, intramuscular (solution)

DRUG

Folic/folinic acid

Pharmaceutical form: tablet Route of administration: oral Folic/folinic acid continued according to local standard.

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States
  • Colombia
  • Czechia
  • Italy
  • Mexico
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01217814 on ClinicalTrials.gov