ClinicalTrials.gg
CompletedNCT01000441ROCUpdated Jan 20, 2026

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

A Phase 4 interventional study of infliximab, etanercept, adalimumab and abatacept, rituximab or tocilizumab in Rheumatoid Arthritis, sponsored by University Hospital, Strasbourg, France. Completed at 44 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-20.

Sponsored by University Hospital, Strasbourg, France · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Rheumatoid Arthritis

Keywords

  • Rheumatoid arthritis with inadequate response to 1 anti-TNF
03

In context

Arthritis, Rheumatoid

3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.

This study's enrollment of 300 is above the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 999 studies on the registry; 358 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (\< or = to 10 mg/day of prednisone equivalent)during the preceding month

Exclusion criteria

Exclusion Criteria:

  • Counter-indication to other anti-TNF, abatacept, rituximab or tocilizumab
  • Pregnancy
  • Age \< 18 years
  • Impossibility to give
  • Impossibility to be followed for 12 months
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (actual)

Study arms

  • 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

Interventions

06

What researchers measure

Primary outcomes

  1. Proportion of EULAR responders

    Time frame: 6 months

07

Study locations

44 sites
  • 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
  • Centre Hospitalier Départemental Les Oudairies
    La Roche-sur-Yon, France
  • Groupe Hospitalier du Havre - Hôpital J.Monod
    Le Havre, France
  • Hôpital Bicêtre
    Le Kremlin-Bicêtre, France
  • Centre Hospitalier du Mans
    Le Mans, France
  • Polyclinique de Riaumont
    Liévin, 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
    Orléans, 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
    Vandœuvre-lès-Nancy, France
  • Centre Hospitalier - Princesse Grâce de Monaco
    Monaco, Monaco
08

References and documents

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 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2009 to primary completion in Aug 2013, 43 months.

Of 79 non-industry phase 4 interventional studies under Arthritis, Rheumatoid, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 92. This study's 43 months is below that.

Counting every sponsor, half of 104 studies reached it within 42 months; a quarter within 25 and three quarters within 74.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2009
First posted
Oct 23, 2009
StartActual
Dec 23, 2009
Primary completionActual
Aug 12, 2013
CompletionActual
Aug 12, 2013
Last update
Jan 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01000441
Responsible party
Sponsor
First posted
Oct 23, 2009
Start date
Dec 23, 2009
Primary completion
Aug 12, 2013
Completion
Aug 12, 2013
Last update
Jan 20, 2026

Study contacts

Jacques-Eric GOTTENBERG, MD, PhD
principal investigator · Hôpitaux Universitaires de Strasbourg

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Infliximab · Etanercept · Adalimumab

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