Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis (ROC)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University Hospital, Strasbourg, France.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Hospital, Strasbourg, France
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01000441
First received: October 22, 2009
Last updated: June 25, 2010
Last verified: June 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: infliximab, etanercept, adalimumab Drug: abatacept, rituximab or tocilizumab |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis |
Resource links provided by NLM:
Further study details as provided by University Hospital, Strasbourg, France:
Primary Outcome Measures:
- Proportion of EULAR responders [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000441
Contacts
| Contact: Jacques-Eric GOTTENBERG, MD, PhD | +0 (33) 3 88128189 | jacques-eric.gottenberg@chru-strasbourg.fr |
| Contact: Jean SIBILIA, MD | +0 (33) 3 88127955 | jean.sibilia@chru-strasbourg.fr |
Locations
| France | |
| 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 | |
| Groupe Hospitalier Diaconesses - Hôpital de la Croix Saint-Simon | Recruiting |
| Paris, France | |
| Contact: Jean-Marc ZIZA, MD | |
| Principal Investigator: Jean-Marc ZIZA, MD | |
| Hôpital Saint-Antoine | Not yet recruiting |
| Paris, France | |
| Contact: Francis BERENBAUM, MD | |
| Principal Investigator: Francis BERENBAUM, 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 Bichat | Not yet recruiting |
| Paris, France | |
| Contact: Olivier MEYER, MD | |
| Principal Investigator: Olivier MEYER, MD | |
| CHU Chenevier - Mondor | Not yet recruiting |
| Paris, France | |
| Contact: Pascal CLAUDEPIERRE, MD | |
| Principal Investigator: Pascal CLAUDEPIERRE, 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 | |
| Monaco | |
| 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
Investigators
| Principal Investigator: | Jacques-Eric GOTTENBERG, MD, PhD | Hôpitaux Universitaires de Strasbourg |
More Information
No publications provided
| Responsible Party: | Christine GEILLER, Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg |
| ClinicalTrials.gov Identifier: | NCT01000441 History of Changes |
| Other Study ID Numbers: | 4507 |
| Study First Received: | October 22, 2009 |
| Last Updated: | June 25, 2010 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Strasbourg, France:
|
Rheumatoid arthritis with inadequate response to 1 anti-TNF |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Rituximab Abatacept TNFR-Fc fusion protein Infliximab Adalimumab Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents Immunosuppressive Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Gastrointestinal Agents Central Nervous System Agents Dermatologic Agents |
ClinicalTrials.gov processed this record on June 17, 2013