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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
Sponsor:
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
  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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01000441

Locations
France
Polyclinique de Picardie
Amiens, France
Centre Hospitalier de Belfort-Montbéliard
Belfort, France
CHU de Besançon - Hôpital Jean Minjoz
Besançon, France
Hôpital Jean Verdier
Bondy, France
CHU Bordeaux - Hôpital Pellegrin
Bordeaux, France
Hôpital Ambroise Paré
Boulogne - Billancourt, France
CHU de la Cavale Blanche
Brest, France
CHU de Caen
Caen, France
Centre Hospitalier Jean Rougié
Cahors, France
Centre Hospitalier de Cannes
Cannes, France
CHU Gabriel Montpied
Clermont-Ferrand, France
Hôpitaux Civils de Colmar
Colmar, France
CHU de Grenoble - Hôpital Sud
Grenoble, France
Hôpital Bicêtre
Kremlin Bicetre, France
Centre Hospitalier Départemental Les Oudairies
La Roche Sur Yon, France
Groupe Hospitalier du Havre - Hôpital J.Monod
Le Havre, France
Centre Hospitalier du Mans
Le Mans, France
Polyclinique de Riaumont
Lievin, France
CHRU Lille - Hôpital Salengro
Lille, France
CHU de Limoges
Limoges, France
CH Saint Philibert
Lomme, France
Hôpital de la Conception
Marseille, France
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, France
CHU Montpellier, Hôpital Lapeyronie
Montpellier, France
Centre Hospitalier de Mulhouse - Hôpital Emile Muller
Mulhouse, France
CHU de Nantes - Hôtel Dieu
Nantes, France
CHU de Nice - Hôpital de l'Archet 1
Nice, France
Centre Hospitalier Régional d'Orléans, Hôpital de la Source
Orleans, France
CHU Chenevier - Mondor
Paris, France
Groupe Hospitalier Diaconesses - Hôpital de la Croix Saint-Simon
Paris, France
Hôpital Bichat
Paris, France
Hôpital de la Pitié Salpétrière
Paris, France
Hôpital Lariboisière
Paris, France
Hôpital Saint-Antoine
Paris, France
CHU de Poitiers - Hôpital de la Milétrie
Poitiers, France
Centre Hospitalier René Dubos
Pontoise, France
CHU de Reims - Hôpital Maison Blanche
Reims, France
CHU de Rennes - Hôpital Sud
Rennes, France
CHU de Rouen - Hôpital Bois Guillaume
Rouen, France
CHU de Saint-Etienne
Saint-Etienne, France
Hôpital de Hautepierre
Strasbourg, France
CHU de Toulouse - Hôpital Purpan
Toulouse, France
CHU de Nancy - Hôpital Brabois
Vandoeuvre-les-nancy, France
Monaco
Centre Hospitalier - Princesse Grâce de Monaco
Monaco, Monaco
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Jacques-Eric GOTTENBERG, MD, PhD Hôpitaux Universitaires de Strasbourg
  More Information

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
Etanercept
Abatacept
Adalimumab
Infliximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Immunosuppressive Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on December 09, 2016