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

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Completed
CT.gov ID
NCT01000441
Collaborator
(none)
300
Enrollment
44
Locations
2
Arms
43.6
Actual Duration (Months)
6.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: infliximab, etanercept, adalimumab
  • Drug: abatacept, rituximab or tocilizumab
 Phase 4

Study Design

Study Type:
Interventional
Actual 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
Actual Study Start Date :
Dec 23, 2009
Actual Primary Completion Date :
Aug 12, 2013
Actual Study Completion Date :
Aug 12, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Proportion of EULAR responders [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Polyclinique de Picardie Amiens France
2 Centre Hospitalier de Belfort-Montbéliard Belfort France
3 CHU de Besançon - Hôpital Jean Minjoz Besançon France
4 Hôpital Jean Verdier Bondy France
5 CHU Bordeaux - Hôpital Pellegrin Bordeaux France
6 Hôpital Ambroise Paré Boulogne - Billancourt France
7 CHU de la Cavale Blanche Brest France
8 CHU de Caen Caen France
9 Centre Hospitalier Jean Rougié Cahors France
10 Centre Hospitalier de Cannes Cannes France
11 CHU Gabriel Montpied Clermont-Ferrand France
12 Hôpitaux Civils de Colmar Colmar France
13 CHU de Grenoble - Hôpital Sud Grenoble France
14 Hôpital Bicêtre Kremlin Bicetre France
15 Centre Hospitalier Départemental Les Oudairies La Roche Sur Yon France
16 Groupe Hospitalier du Havre - Hôpital J.Monod Le Havre France
17 Centre Hospitalier du Mans Le Mans France
18 Polyclinique de Riaumont Lievin France
19 CHRU Lille - Hôpital Salengro Lille France
20 CHU de Limoges Limoges France
21 CH Saint Philibert Lomme France
22 Hôpital de la Conception Marseille France
23 CHU de Montpellier - Hôpital Lapeyronie Montpellier France
24 CHU Montpellier, Hôpital Lapeyronie Montpellier France
25 Centre Hospitalier de Mulhouse - Hôpital Emile Muller Mulhouse France
26 CHU de Nantes - Hôtel Dieu Nantes France
27 CHU de Nice - Hôpital de l'Archet 1 Nice France
28 Centre Hospitalier Régional d'Orléans, Hôpital de la Source Orleans France
29 CHU Chenevier - Mondor Paris France
30 Groupe Hospitalier Diaconesses - Hôpital de la Croix Saint-Simon Paris France
31 Hôpital Bichat Paris France
32 Hôpital de la Pitié Salpétrière Paris France
33 Hôpital Lariboisière Paris France
34 Hôpital Saint-Antoine Paris France
35 CHU de Poitiers - Hôpital de la Milétrie Poitiers France
36 Centre Hospitalier René Dubos Pontoise France
37 CHU de Reims - Hôpital Maison Blanche Reims France
38 CHU de Rennes - Hôpital Sud Rennes France
39 CHU de Rouen - Hôpital Bois Guillaume Rouen France
40 CHU de Saint-Etienne Saint-Etienne France
41 Hôpital de Hautepierre Strasbourg France
42 CHU de Toulouse - Hôpital Purpan Toulouse France
43 CHU de Nancy - Hôpital Brabois Vandoeuvre-les-nancy France
44 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01000441
Other Study ID Numbers:
  • 4507
First Posted:
Oct 23, 2009
Last Update Posted:
Aug 9, 2021
Last Verified:
Aug 1, 2021
Keywords provided by , ,
Rheumatoid arthritis with inadequate response to 1 anti-TNF
Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Adalimumab
Etanercept
Rituximab
Abatacept
Infliximab

Study Results

No Results Posted as of Aug 9, 2021