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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
infliximab, etanercept, adalimumab
abatacept, rituximab or tocilizumab
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis with inadequate response to 1 anti-TNF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Polyclinique de Picardie
  • Centre Hospitalier de Belfort-Montbéliard
  • CHU de Besançon - Hôpital Jean Minjoz
  • Hôpital Jean Verdier
  • CHU Bordeaux - Hôpital Pellegrin
  • Hôpital Ambroise Paré
  • CHU de la Cavale Blanche
  • CHU de Caen
  • Centre Hospitalier Jean Rougié
  • Centre Hospitalier de Cannes
  • CHU Gabriel Montpied
  • Hôpitaux Civils de Colmar
  • CHU de Grenoble - Hôpital Sud
  • Hôpital Bicêtre
  • Centre Hospitalier Départemental Les Oudairies
  • Groupe Hospitalier du Havre - Hôpital J.Monod
  • Centre Hospitalier du Mans
  • Polyclinique de Riaumont
  • CHRU Lille - Hôpital Salengro
  • CHU de Limoges
  • CH Saint Philibert
  • Hôpital de la Conception
  • CHU de Montpellier - Hôpital Lapeyronie
  • CHU Montpellier, Hôpital Lapeyronie
  • Centre Hospitalier de Mulhouse - Hôpital Emile Muller
  • CHU de Nantes - Hôtel Dieu
  • CHU de Nice - Hôpital de l'Archet 1
  • Centre Hospitalier Régional d'Orléans, Hôpital de la Source
  • CHU Chenevier - Mondor
  • Groupe Hospitalier Diaconesses - Hôpital de la Croix Saint-Simon
  • Hôpital Bichat
  • Hôpital de la Pitié Salpétrière
  • Hôpital Lariboisière
  • Hôpital Saint-Antoine
  • CHU de Poitiers - Hôpital de la Milétrie
  • Centre Hospitalier René Dubos
  • CHU de Reims - Hôpital Maison Blanche
  • CHU de Rennes - Hôpital Sud
  • CHU de Rouen - Hôpital Bois Guillaume
  • CHU de Saint-Etienne
  • Hôpital de Hautepierre
  • CHU de Toulouse - Hôpital Purpan
  • CHU de Nancy - Hôpital Brabois
  • Centre Hospitalier - Princesse Grâce de Monaco

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

arm 1 (2d anti-TNF):

arm 2 (other biotherapy)

Arm Description

infliximab, etanercept, adalimumab

abatacept, rituximab or tocilizumab

Outcomes

Primary Outcome Measures

Proportion of EULAR responders

Secondary Outcome Measures

Full Information

First Posted
October 22, 2009
Last Updated
August 5, 2021
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT01000441
Brief Title
Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis
Acronym
ROC
Official Title
Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 23, 2009 (Actual)
Primary Completion Date
August 12, 2013 (Actual)
Study Completion Date
August 12, 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid arthritis with inadequate response to 1 anti-TNF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
arm 1 (2d anti-TNF):
Arm Type
Active Comparator
Arm Description
infliximab, etanercept, adalimumab
Arm Title
arm 2 (other biotherapy)
Arm Type
Active Comparator
Arm Description
abatacept, rituximab or tocilizumab
Intervention Type
Drug
Intervention Name(s)
infliximab, etanercept, adalimumab
Intervention Type
Drug
Intervention Name(s)
abatacept, rituximab or tocilizumab
Primary Outcome Measure Information:
Title
Proportion of EULAR responders
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques-Eric GOTTENBERG, MD, PhD
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Polyclinique de Picardie
City
Amiens
Country
France
Facility Name
Centre Hospitalier de Belfort-Montbéliard
City
Belfort
Country
France
Facility Name
CHU de Besançon - Hôpital Jean Minjoz
City
Besançon
Country
France
Facility Name
Hôpital Jean Verdier
City
Bondy
Country
France
Facility Name
CHU Bordeaux - Hôpital Pellegrin
City
Bordeaux
Country
France
Facility Name
Hôpital Ambroise Paré
City
Boulogne - Billancourt
Country
France
Facility Name
CHU de la Cavale Blanche
City
Brest
Country
France
Facility Name
CHU de Caen
City
Caen
Country
France
Facility Name
Centre Hospitalier Jean Rougié
City
Cahors
Country
France
Facility Name
Centre Hospitalier de Cannes
City
Cannes
Country
France
Facility Name
CHU Gabriel Montpied
City
Clermont-Ferrand
Country
France
Facility Name
Hôpitaux Civils de Colmar
City
Colmar
Country
France
Facility Name
CHU de Grenoble - Hôpital Sud
City
Grenoble
Country
France
Facility Name
Hôpital Bicêtre
City
Kremlin Bicetre
Country
France
Facility Name
Centre Hospitalier Départemental Les Oudairies
City
La Roche Sur Yon
Country
France
Facility Name
Groupe Hospitalier du Havre - Hôpital J.Monod
City
Le Havre
Country
France
Facility Name
Centre Hospitalier du Mans
City
Le Mans
Country
France
Facility Name
Polyclinique de Riaumont
City
Lievin
Country
France
Facility Name
CHRU Lille - Hôpital Salengro
City
Lille
Country
France
Facility Name
CHU de Limoges
City
Limoges
Country
France
Facility Name
CH Saint Philibert
City
Lomme
Country
France
Facility Name
Hôpital de la Conception
City
Marseille
Country
France
Facility Name
CHU de Montpellier - Hôpital Lapeyronie
City
Montpellier
Country
France
Facility Name
CHU Montpellier, Hôpital Lapeyronie
City
Montpellier
Country
France
Facility Name
Centre Hospitalier de Mulhouse - Hôpital Emile Muller
City
Mulhouse
Country
France
Facility Name
CHU de Nantes - Hôtel Dieu
City
Nantes
Country
France
Facility Name
CHU de Nice - Hôpital de l'Archet 1
City
Nice
Country
France
Facility Name
Centre Hospitalier Régional d'Orléans, Hôpital de la Source
City
Orleans
Country
France
Facility Name
CHU Chenevier - Mondor
City
Paris
Country
France
Facility Name
Groupe Hospitalier Diaconesses - Hôpital de la Croix Saint-Simon
City
Paris
Country
France
Facility Name
Hôpital Bichat
City
Paris
Country
France
Facility Name
Hôpital de la Pitié Salpétrière
City
Paris
Country
France
Facility Name
Hôpital Lariboisière
City
Paris
Country
France
Facility Name
Hôpital Saint-Antoine
City
Paris
Country
France
Facility Name
CHU de Poitiers - Hôpital de la Milétrie
City
Poitiers
Country
France
Facility Name
Centre Hospitalier René Dubos
City
Pontoise
Country
France
Facility Name
CHU de Reims - Hôpital Maison Blanche
City
Reims
Country
France
Facility Name
CHU de Rennes - Hôpital Sud
City
Rennes
Country
France
Facility Name
CHU de Rouen - Hôpital Bois Guillaume
City
Rouen
Country
France
Facility Name
CHU de Saint-Etienne
City
Saint-Etienne
Country
France
Facility Name
Hôpital de Hautepierre
City
Strasbourg
Country
France
Facility Name
CHU de Toulouse - Hôpital Purpan
City
Toulouse
Country
France
Facility Name
CHU de Nancy - Hôpital Brabois
City
Vandoeuvre-les-nancy
Country
France
Facility Name
Centre Hospitalier - Princesse Grâce de Monaco
City
Monaco
Country
Monaco

12. IPD Sharing Statement

Citations:
PubMed Identifier
32212002
Citation
Nguyen MVC, Courtier A, Adrait A, Defendi F, Coute Y, Baillet A, Guigue L, Gottenberg JE, Dumestre-Perard C, Brun V, Gaudin P. Fetuin-A and thyroxin binding globulin predict rituximab response in rheumatoid arthritis patients with insufficient response to anti-TNFalpha. Clin Rheumatol. 2020 Sep;39(9):2553-2562. doi: 10.1007/s10067-020-05030-6. Epub 2020 Mar 24.
Results Reference
derived
PubMed Identifier
31413865
Citation
Virone A, Bastard JP, Fellahi S, Capeau J, Rouanet S, Sibilia J, Ravaud P, Berenbaum F, Gottenberg JE, Sellam J. Comparative effect of tumour necrosis factor inhibitors versus other biological agents on cardiovascular risk-associated biomarkers in patients with rheumatoid arthritis. RMD Open. 2019 Jul 21;5(2):e000897. doi: 10.1136/rmdopen-2019-000897. eCollection 2019.
Results Reference
derived
PubMed Identifier
29884223
Citation
Riviere E, Sellam J, Pascaud J, Ravaud P, Gottenberg JE, Mariette X. Serum IL-33 level is associated with auto-antibodies but not with clinical response to biologic agents in rheumatoid arthritis. Arthritis Res Ther. 2018 Jun 8;20(1):122. doi: 10.1186/s13075-018-1628-6.
Results Reference
derived
PubMed Identifier
27654603
Citation
Gottenberg JE, Brocq O, Perdriger A, Lassoued S, Berthelot JM, Wendling D, Euller-Ziegler L, Soubrier M, Richez C, Fautrel B, Constantin AL, Mariette X, Morel J, Gilson M, Cormier G, Salmon JH, Rist S, Liote F, Marotte H, Bonnet C, Marcelli C, Sellam J, Meyer O, Solau-Gervais E, Guis S, Ziza JM, Zarnitsky C, Chary-Valckenaere I, Vittecoq O, Saraux A, Pers YM, Gayraud M, Bolla G, Claudepierre P, Ardizzone M, Dernis E, Breban MA, Fain O, Balblanc JC, Aberkane O, Vazel M, Back C, Candon S, Chatenoud L, Perrodeau E, Sibilia J, Ravaud P. Non-TNF-Targeted Biologic vs a Second Anti-TNF Drug to Treat Rheumatoid Arthritis in Patients With Insufficient Response to a First Anti-TNF Drug: A Randomized Clinical Trial. JAMA. 2016 Sep 20;316(11):1172-1180. doi: 10.1001/jama.2016.13512.
Results Reference
derived

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

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