Efficacy of a Sequential Treatment Strategy in Rheumatoid Arthritis
Recruiting
Phase 3
Interventional Study
Rheumatoid Arthritis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 220 (estimated)
- Sponsor
- University Hospital, Montpellier · Other
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About This Trial
In rheumatoid arthritis (RA), the consensual 1st line conventional synthetic disease modifying antirheumatic drugs (csDMARD) of RA is methotrexate (MTX). In case of contra-indication or intolerance to MTX, leflunomide is an alternative. If the treatment target is not achieved with csDMARD strategy, addition of a biological DMARD (TNF inhibitors, anti-Interleukin 6 (anti-IL6)), abatacept, or rituxi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Aged between 18 or above
* Rheumatoid arthritis according to ACR-EULAR 2010 (American College of Rheumatology-European League Against Rheumatism)
* ACPA positive
* Under methotrexate or leflunomide treatment for at least 3 months
* DAS28-CRP\>3.2 under methotrexate or leflunom…
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