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

University Hospital, Strasbourg, France

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: abatacept, rituximab or tocilizumab; Drug: infliximab, etanercept, adalimumab

Study type: Interventional

Funder types: Other

Identifiers

NCT01000441

4507

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

arm 1 (2d anti-TNF):

Active Comparator group

Description:

infliximab, etanercept, adalimumab

Treatment:

Drug: infliximab, etanercept, adalimumab

arm 2 (other biotherapy)

Active Comparator group

Description:

abatacept, rituximab or tocilizumab

Treatment:

Drug: abatacept, rituximab or tocilizumab