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Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis (ROC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01000441
Recruitment Status : Unknown
Verified June 2010 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : October 23, 2009
Last Update Posted : June 28, 2010
Sponsor:
Information provided by:
University Hospital, Strasbourg, France

Tracking Information
First Submitted Date  ICMJE October 22, 2009
First Posted Date  ICMJE October 23, 2009
Last Update Posted Date June 28, 2010
Study Start Date  ICMJE December 2009
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2009)
Proportion of EULAR responders [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 22, 2009)
Variation of DAS28 criteria [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis
Official Title  ICMJE Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis
Brief Summary Approximately 30% of patients with rheumatoid arthritis have an inadequate response to anti-TNF (primarily or loss of response), leaving two alternatives: rotation to a second anti-TNF or change of biologic, with a different mechanism of action, such as abatacept, rituximab and tocilizumab. No controlled trial compared these two strategies face to face. The present objective is to investigate the issue whether one of these strategies could have a better efficacy in a pragmatic trial in the setting of current practice.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: infliximab, etanercept, adalimumab
  • Drug: abatacept, rituximab or tocilizumab
Study Arms  ICMJE
  • Active Comparator: arm 1 (2d anti-TNF):
    infliximab, etanercept, adalimumab
    Intervention: Drug: infliximab, etanercept, adalimumab
  • Active Comparator: arm 2 (other biotherapy)
    abatacept, rituximab or tocilizumab
    Intervention: Drug: abatacept, rituximab or tocilizumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 22, 2009)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2013
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Active and erosive rheumatoid arthritis with a DAS28 equal or greater than 3.2
  • Inadequate response to a 1st anti-TNF
  • Stable or no treatment with any DMARDs, or oral corticosteroids (< or = to 10 mg/day of prednisone equivalent)during the preceding month

Exclusion Criteria:

  • Counter-indication to other anti-TNF, abatacept, rituximab or tocilizumab
  • Pregnancy
  • Age < 18 years
  • Impossibility to give informed consent
  • Impossibility to be followed for 12 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Monaco
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01000441
Other Study ID Numbers  ICMJE 4507
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christine GEILLER, Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg
Study Sponsor  ICMJE University Hospital, Strasbourg, France
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jacques-Eric GOTTENBERG, MD, PhD Hôpitaux Universitaires de Strasbourg
PRS Account University Hospital, Strasbourg, France
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP