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

NCT01061736 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1675

Last updated 2017-06-28

Study results available
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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.

Conditions

Interventions

DRUG

Sarilumab

Pharmaceutical form: solution for injection Route of administration: subcutaneous

DRUG

Placebo (for sarilumab)

Pharmaceutical form: solution for injection Route of administration: subcutaneous

DRUG

Methotrexate

Same weekly dose as received prior to enrollment

DRUG

Folic Acid

According to local standard

Sponsors & Collaborators

Principal Investigators

  • Mark C Genovese, MD, Professor of Medicine · Division of Immunology and Rheumatology - Stanford University - USA

  • TWJ Huizinga, Prof Dr · Dpt of Rheumatology - Leiden University Medical Center - The Netherlands

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
2010-03-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Colombia
  • Czechia
  • Egypt
  • Estonia
  • Finland
  • Germany
  • Greece
  • Hungary
  • India
  • Lithuania
  • Malaysia
  • Mexico
  • Netherlands
  • New Zealand
  • Norway
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

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 NCT01061736 on ClinicalTrials.gov