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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. 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
Information provided by:
University Hospital, Strasbourg, France

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: infliximab, etanercept, adalimumab Drug: abatacept, rituximab or tocilizumab Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis
Study Start Date : December 2009
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: arm 1 (2d anti-TNF):
infliximab, etanercept, adalimumab
Drug: infliximab, etanercept, adalimumab
Active Comparator: arm 2 (other biotherapy)
abatacept, rituximab or tocilizumab
Drug: abatacept, rituximab or tocilizumab

Primary Outcome Measures :
  1. Proportion of EULAR responders [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01000441

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Contact: Jacques-Eric GOTTENBERG, MD, PhD +0 (33) 3 88128189
Contact: Jean SIBILIA, MD +0 (33) 3 88127955

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Sponsors and Collaborators
University Hospital, Strasbourg, France
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Principal Investigator: Jacques-Eric GOTTENBERG, MD, PhD Hôpitaux Universitaires de Strasbourg
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Christine GEILLER, Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg Identifier: NCT01000441    
Other Study ID Numbers: 4507
First Posted: October 23, 2009    Key Record Dates
Last Update Posted: June 28, 2010
Last Verified: June 2010
Keywords provided by University Hospital, Strasbourg, France:
Rheumatoid arthritis with inadequate response to 1 anti-TNF
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Immunosuppressive Agents
Dermatologic Agents