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An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

NCT01764997 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 776

Last updated 2017-07-27

Study results available
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Summary

Primary Objective:

To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to etanercept and MTX in participants with rheumatoid arthritis (RA) and an inadequate response to adalimumab and MTX by evaluation of the Disease Activity Score for 28 joints (DAS28).

Secondary Objectives:

To assess the signs and symptoms of RA in participants taking sarilumab in combination with MTX.

To assess the quality of life of participants with RA taking sarilumab in combination with MTX.

To assess the safety and tolerability of sarilumab in combination with MTX in participants with RA.

Conditions

Interventions

DRUG

Sarilumab

Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous

DRUG

Etanercept

Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous

DRUG

Methotrexate

Dispensed according to local practice.

DRUG

Placebo (for sarilumab)

DRUG

Placebo (for etanercept)

DRUG

Adalimumab

Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Chile
  • Colombia
  • Czechia
  • Ecuador
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Latvia
  • Lithuania
  • Malaysia
  • Mexico
  • New Zealand
  • Peru
  • Poland
  • Romania
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Ukraine
  • United Kingdom

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 NCT01764997 on ClinicalTrials.gov