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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01000441
Acronym
ROC
Enrollment
300
Registered
2009-10-23
Start date
2009-12-23
Completion date
2013-08-12
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis with inadequate response to 1 anti-TNF

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.

Interventions

DRUGinfliximab, etanercept, adalimumab
DRUGabatacept, rituximab or tocilizumab

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Proportion of EULAR responders6 months

Countries

France, Monaco

Contacts

PRINCIPAL_INVESTIGATORJacques-Eric GOTTENBERG, MD, PhD

Hôpitaux Universitaires de Strasbourg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026