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AzTrials

Rheumatoid ArthritisPhase 4ROCNCT01000441

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

A Phase 4 study testing infliximab, etanercept, adalimumab and abatacept, rituximab or tocilizumab in people with Rheumatoid Arthritis, run by University Hospital, Strasbourg, France at 44 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
infliximab, etanercept, adalimumab and abatacept, rituximab or tocilizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
44 sitesin 2 countries
Study dates
23 Dec 2009to 12 Aug 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

44 sites in 2 countries.

44 sites in 2 countries

France43 sites

  • Polyclinique de Picardie

    Amiens

  • Centre Hospitalier de Belfort-Montbéliard

    Belfort

  • CHU de Besançon - Hôpital Jean Minjoz

    Besançon

  • Hôpital Jean Verdier

    Bondy

  • CHU Bordeaux - Hôpital Pellegrin

    Bordeaux

  • Hôpital Ambroise Paré

    Boulogne-Billancourt

  • CHU de la Cavale Blanche

    Brest

  • CHU de Caen

    Caen

  • Centre Hospitalier Jean Rougié

    Cahors

  • Centre Hospitalier de Cannes

    Cannes

  • CHU Gabriel Montpied

    Clermont-Ferrand

  • Hôpitaux Civils de Colmar

    Colmar

  • CHU de Grenoble - Hôpital Sud

    Grenoble

  • Centre Hospitalier Départemental Les Oudairies

    La Roche-sur-Yon

  • Groupe Hospitalier du Havre - Hôpital J.Monod

    Le Havre

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre

  • Centre Hospitalier du Mans

    Le Mans

  • Polyclinique de Riaumont

    Liévin

  • CHRU Lille - Hôpital Salengro

    Lille

  • CHU de Limoges

    Limoges

  • CH Saint Philibert

    Lomme

  • Hôpital de la Conception

    Marseille

  • CHU de Montpellier - Hôpital Lapeyronie

    Montpellier

  • CHU Montpellier, Hôpital Lapeyronie

    Montpellier

  • Centre Hospitalier de Mulhouse - Hôpital Emile Muller

    Mulhouse

  • CHU de Nantes - Hôtel Dieu

    Nantes

  • CHU de Nice - Hôpital de l'Archet 1

    Nice

  • Centre Hospitalier Régional d'Orléans, Hôpital de la Source

    Orléans

  • CHU Chenevier - Mondor

    Paris

  • Groupe Hospitalier Diaconesses - Hôpital de la Croix Saint-Simon

    Paris

  • Hôpital Bichat

    Paris

  • Hôpital de la Pitié Salpétrière

    Paris

  • Hôpital Lariboisière

    Paris

  • Hôpital Saint-Antoine

    Paris

  • CHU de Poitiers - Hôpital de la Milétrie

    Poitiers

  • Centre Hospitalier René Dubos

    Pontoise

  • CHU de Reims - Hôpital Maison Blanche

    Reims

  • CHU de Rennes - Hôpital Sud

    Rennes

  • CHU de Rouen - Hôpital Bois Guillaume

    Rouen

  • CHU de Saint-Etienne

    Saint-Etienne

  • Hôpital de Hautepierre

    Strasbourg

  • CHU de Toulouse - Hôpital Purpan

    Toulouse

  • CHU de Nancy - Hôpital Brabois

    Vandœuvre-lès-Nancy

Other trials in France

Monaco1 site

  • Centre Hospitalier - Princesse Grâce de Monaco

    Monaco

Other trials in Monaco

About this study

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.

Being tested
infliximab, etanercept, adalimumab, abatacept, rituximab or tocilizumab
Keywords
Rheumatoid arthritis with inadequate response to 1 anti-TNF
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • infliximab, etanercept, adalimumabDrug

  • abatacept, rituximab or tocilizumabDrug

Study groups in NCT01000441
Study groupRoleWhat they receive
arm 1 (2d anti-TNF):Active comparatorinfliximab, etanercept, adalimumab
Receives: Drug: infliximab, etanercept, adalimumab
arm 2 (other biotherapy)Active comparatorabatacept, rituximab or tocilizumab
Receives: Drug: abatacept, rituximab or tocilizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of EULAR responders

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2009 (estimated)
  2. Study start23 Dec 2009
  3. Primary completion12 Aug 2013
  4. Study completion12 Aug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01000441
Sponsor's protocol ID
4507
Acronym
ROC
Status last verified
Jan 2026
First submitted
22 Oct 2009
Last updated
20 Jan 2026
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 27654603

  • 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.

    PubMed 32212002

  • 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.

    PubMed 31413865

  • 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.

    PubMed 29884223

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing infliximab, etanercept, adalimumab and abatacept, rituximab or tocilizumab in people with Rheumatoid Arthritis, run by University Hospital, Strasbourg, France at 44 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in France, Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of EULAR responders (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01000441, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.

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