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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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Polyclinique de Picardie Not yet recruiting
Amiens, France
Contact: Patrick BOUMIER, MD         
Principal Investigator: Patrick BOUMIER, MD         
Centre Hospitalier de Belfort-Montbéliard Recruiting
Belfort, France
Contact: Jean-Charles BALBLANC, MD         
Principal Investigator: Jean-Charles BALBLANC, MD         
CHU de Besançon - Hôpital Jean Minjoz Recruiting
Besançon, France
Contact: Daniel WENDLING, MD         
Principal Investigator: Daniel WENDLING, MD         
Hôpital Jean Verdier Not yet recruiting
Bondy, France
Contact: Olivier FAIN, MD         
Principal Investigator: Olivier FAIN, MD         
CHU Bordeaux - Hôpital Pellegrin Not yet recruiting
Bordeaux, France
Contact: Thierry SCHAEVERBEKE, MD         
Principal Investigator: Thierry SCHAEVERBEKE, MD         
Hôpital Ambroise Paré Recruiting
Boulogne - Billancourt, France
Contact: Maxime BREBAN, MD         
Principal Investigator: Maxime BREBAN, MD         
CHU de la Cavale Blanche Not yet recruiting
Brest, France
Contact: Alain SARRAUX, MD         
Principal Investigator: Alain SARRAUX, MD         
CHU de Caen Not yet recruiting
Caen, France
Contact: Christian MARCELLI, MD         
Principal Investigator: Christian MARCELLI, MD         
Centre Hospitalier Jean Rougié Recruiting
Cahors, France
Contact: Slim LASSOUED, MD         
Principal Investigator: Slim LASSOUED, MD         
Centre Hospitalier de Cannes Not yet recruiting
Cannes, France
Contact: Gilles BOLLA, MD         
Principal Investigator: Gilles BOLLA, MD         
CHU Gabriel Montpied Not yet recruiting
Clermont-Ferrand, France
Contact: Martin SOUBRIER, MD         
Principal Investigator: Martin SOUBRIER, MD         
Hôpitaux Civils de Colmar Not yet recruiting
Colmar, France
Contact: Paul MOREAU, MD         
Principal Investigator: Paul MOREAU, MD         
CHU de Grenoble - Hôpital Sud Not yet recruiting
Grenoble, France
Contact: Mélanie GILSON         
Principal Investigator: Mélanie GILSON, MD         
Hôpital Bicêtre Recruiting
Kremlin Bicetre, France
Contact: Xavier MARIETTE, MD         
Principal Investigator: Xavier MARIETTE, MD         
Centre Hospitalier Départemental Les Oudairies Recruiting
La Roche Sur Yon, France
Contact: Grégoire CORMIER, MD         
Principal Investigator: Grégoire CORMIER, MD         
Groupe Hospitalier du Havre - Hôpital J.Monod Not yet recruiting
Le Havre, France
Contact: Didier ALCAIX, MD         
Principal Investigator: Didier ALCAIX, MD         
Centre Hospitalier du Mans Not yet recruiting
Le Mans, France
Contact: Emmanuelle DERNIS, MD         
Principal Investigator: Emmanuelle DERNIS, MD         
Polyclinique de Riaumont Not yet recruiting
Lievin, France
Contact: Jean-Louis LEGRAND, MD         
Principal Investigator: Jean-Louis LEGRAND, MD         
CHRU Lille - Hôpital Salengro Not yet recruiting
Lille, France
Contact: René-Marc FLIPPO, MD         
Principal Investigator: René-Marc FLIPPO, MD         
CHU de Limoges Not yet recruiting
Limoges, France
Contact: Philippe BERTIN, MD         
Principal Investigator: Philippe BERTIN, MD         
CH Saint Philibert Not yet recruiting
Lomme, France
Contact: Hélène LURASCHI, MD         
Principal Investigator: Hélène LURASCHI, MD         
Hôpital de la Conception Not yet recruiting
Marseille, France
Contact: Sandrine GUIS         
Principal Investigator: Sandrine GUIS, MD         
Hôpital de la Conception Not yet recruiting
Marseille, France
Contact: Pierre LAFFORGUE, MD         
Principal Investigator: Pierre LAFFORGUE, MD         
CHU de Montpellier - Hôpital Lapeyronie Not yet recruiting
Montpellier, France
Contact: Christian JORGENSEN, MD         
Principal Investigator: Christian JORGENSEN, MD         
CHU Montpellier, Hôpital Lapeyronie Not yet recruiting
Montpellier, France
Contact: Jacques Morel, MD         
Principal Investigator: Jacques MOREL, MD         
Centre Hospitalier de Mulhouse - Hôpital Emile Muller Not yet recruiting
Mulhouse, France
Contact: Marc ARDIZZONE, MD         
Principal Investigator: Marc ARDIZZONE, MD         
CHU de Nantes - Hôtel Dieu Recruiting
Nantes, France
Contact: Jean-Marie BERTHELOT, MD         
Principal Investigator: Jean-Marie BERTHELOT, MD         
CHU de Nice - Hôpital de l'Archet 1 Recruiting
Nice, France
Contact: Liana EULLER-ZIEGLER, MD         
Principal Investigator: Liana EULLER-ZIEGLER, MD         
Centre Hospitalier Régional d'Orléans, Hôpital de la Source Not yet recruiting
Orleans, France
Contact: Stéphanie RIST, MD         
Principal Investigator: Stéphanie RIST, MD         
CHU Chenevier - Mondor Not yet recruiting
Paris, France
Contact: Pascal CLAUDEPIERRE, MD         
Principal Investigator: Pascal CLAUDEPIERRE, MD         
Groupe Hospitalier Diaconesses - Hôpital de la Croix Saint-Simon Recruiting
Paris, France
Contact: Jean-Marc ZIZA, MD         
Principal Investigator: Jean-Marc ZIZA, MD         
Hôpital Bichat Not yet recruiting
Paris, France
Contact: Olivier MEYER, MD         
Principal Investigator: Olivier MEYER, MD         
Hôpital de la Pitié Salpétrière Recruiting
Paris, France
Contact: Bruno FAUTREL, MD         
Principal Investigator: Bruno FAUTREL, MD         
Hôpital Lariboisière Recruiting
Paris, France
Contact: Frédéric LIOTE, MD         
Principal Investigator: Frederic LIOTE, MD         
Hôpital Saint-Antoine Not yet recruiting
Paris, France
Contact: Francis BERENBAUM, MD         
Principal Investigator: Francis BERENBAUM, MD         
CHU de Poitiers - Hôpital de la Milétrie Not yet recruiting
Poitiers, France
Contact: Elisabeth SOLAU-GERVAIS, MD         
Principal Investigator: Elisabeth SOLAU-GERVAIS, MD         
Centre Hospitalier René Dubos Not yet recruiting
Pontoise, France
Contact: Edouard PERTUISET, MD         
Principal Investigator: Edouard PERTUISET, MD         
CHU de Reims - Hôpital Maison Blanche Recruiting
Reims, France
Contact: Jean-Paul ESCHARD, MD         
Principal Investigator: Jean-Paul ESCHARD, MD         
CHU de Rennes - Hôpital Sud Not yet recruiting
Rennes, France
Contact: Aleth PERDRIGER, MD         
Principal Investigator: Aleth PERDRIGER, MD         
CHU de Rouen - Hôpital Bois Guillaume Not yet recruiting
Rouen, France
Contact: Olivier VITTECOQ, MD         
Principal Investigator: Olivier VITTECOQ, MD         
CHU de Saint-Etienne Not yet recruiting
Saint-Etienne, France
Contact: Thierry THOMAS, MD         
Principal Investigator: Thierry THOMAS, MD         
Hôpital de Hautepierre Recruiting
Strasbourg, France
Contact: Jacques-Eric GOTTENBERG, MD         
Principal Investigator: Jacques-Eric GOTTENBERG, MD         
CHU de Toulouse - Hôpital Purpan Not yet recruiting
Toulouse, France
Contact: Alain CANTAGREL, MD         
Principal Investigator: Alain CANTAGREL, MD         
CHU de Nancy - Hôpital Brabois Not yet recruiting
Vandoeuvre-les-nancy, France
Contact: Isabelle VALCKENAERE, MD         
Principal Investigator: Isabelle VALCKENAERE, MD         
Centre Hospitalier - Princesse Grâce de Monaco Recruiting
Monaco, Monaco
Contact: Olivier BROCQ, MD         
Principal Investigator: Olivier BROCQ, MD         
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     History of Changes
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
Dermatologic Agents
Gastrointestinal Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Immunosuppressive Agents