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Clinical Trials/PER-033-13
PER-033-13
Unknown
未知

A RANDOMIZED, DOUBLE-BLIND, PARALLEL, PLACEBO-CONTROLLED STUDY ASSESSING THE EFFICACY AND SAFETY OF SARILUMAB ADDED TO NON-BIOLOGIC DMARD THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS WHO ARE INADEQUATE RESPONDERS TO OR INTOLERANT OF TNF-α ANTAGONISTS

Sanofi Aventis Recherche & Development,0 sites67 target enrollmentFebruary 18, 2014
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Conditions-M069M069

Overview

Phase
未知
Intervention
Not specified
Conditions
-M069
Sponsor
Sanofi Aventis Recherche & Development,
Enrollment
67
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 18, 2014
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Sanofi Aventis Recherche & Development,

Eligibility Criteria

Inclusion Criteria

  • •Diagnosis of rheumatoid arthritis ≥6 months duration, according to the American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) 2010 Rheumatoid Arthritis Classification Criteria
  • •ACR Class I\-III functional status, based on 1991 revised criteria
  • •Patients who, per Investigator assessment, have had an inadequate response to at least one TNF antagonist, after being treated for at least 3 consecutive months, any time before screening or patients intolerant to at least 1 TNF antagonist, resulting in discontinuation
  • •\- TNF\-antagonists may include etanercept, infliximab,
  • •adalimumab, golimumab and/or certolizumab pegol
  • •Active disease defined as:
  • •\- at least 6 of 66 swollen joints and 8 of 68 tender at screening and baseline visits, and
  • •\- hs\-CRP ≥8 mg/L at screening
  • •Continuous treatment with one or a combination of non\-biologic DMARDs (except for simultaneous combination use of leflunomide and methotrexate) for at least 12 consecutive weeks prior to randomization and on a stable dose(s) for at least 6 consecutive weeks prior to screening.
  • •Patients who have signed a written informed consent prior to performance of any study\-related procedures.

Exclusion Criteria

  • •Age \<18 years
  • •Treatment with TNF antagonists as follows:
  • •\- Etanercept: Within 28 days prior to randomization
  • •\- Infliximab, adalimumab, golimumab and certolizumab pegol: Within 42 days prior to randomization
  • •Treatment with RA\-directed biologic agents with non\-TNF\-α antagonist mechanisms as follows:
  • •\- Anakinra: Within 28 days prior to randomization
  • •\- Abatacept: Within 42 days prior to randomization
  • •\- Rituximab or other cell depleting agent: Within 6 months prior to randomization or until total lymphocyte count and CD 19\+ lymphocyte count are normalized, whichever is longer
  • •Prior treatment with anti\-interleukin\-6 (anti\-IL\-6\) or anti\-interleukin\-6 receptor (IL\-6R) antagonist therapies, including but not limited to tocilizumab or sarilumab
  • •Use of oral glucocorticoid greater than prednisone 10 mg per day or equivalent per day, or a change in dosage within 4 weeks prior to randomization

Outcomes

Primary Outcomes

Not specified

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