Status:
RECRUITING
Efficacy of a Sequential Treatment Strategy in Rheumatoid Arthritis
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
In rheumatoid arthritis (RA), the consensual 1st line conventional synthetic disease modifying antirheumatic drugs (csDMARD) of RA is methotrexate (MTX) (1). In case of contra-indication or intoleranc...
Eligibility Criteria
Inclusion
- 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 leflunomide calculated with CRP dated less than 7 days from baseline
- Escape under synthetic background treatment defined by an elevation of C-reactive protein (CRP) (CRP\> 5mg/L ) or Erythrocyte sedimentation rate (ESR) (for men: \> age in years/2 ; for women: \> age (+10) /2)) within the last 6 months before baseline
- Targeted DMARDs (biological and targeted synthetic DMARDs) naïve
- Indication for a TNF inhibitor
Exclusion
- Subject unable to read or/and write
- Planned longer stay outside the region that prevents compliance with the visit plan
- Subject unable to sign informed consent form
- Subject not covered by public health insurance
- Dementia
- Fibromyalgia
- Contra-indications to TNF inhibitor and/or Abatacept
- Absence of tuberculosis screening in the previous 3 months before baseline
- Patient with untreated active tuberculosis
- Patient who cannot be followed during 48 weeks
- Drug addiction, addiction to alcohol
- Protected populations according to the French Public Health Code Articles L1121-5,6,8 (For example, pregnant, parturient or lactating women, prisoners, adults under guardianship or otherwise unable to consent).
- Women of child bearing potential, unless they are using an effective method of birth control
- Patient under law protection
- Prisoners
- Subject who are in a dependency or employment with the sponsor or the investigator
- Participation in another interventional clinical trial or administration of an investigational product within the last 4 weeks before the screening date
- Subject with moderate to severe heart failure (class 3 or class 4 cardiac disease as defined by the New York Heart Association Functional Classification)
- Patients had a history of chronic obstructive pulmonary disease (COPD) and heavy smoking
- Patients had a planned surgical procedure at least 30 days before the screening day
- Known allergy or intolerance to an anti-TNF therapy
- Hypersensitivity to the Abatacept or to any of its excipients
- Patient with untreated active hepatitis B
- Patient vaccinated with a live vaccine within 30 days prior to screening
- Patients with an Inflammatory Bowel Disease (IBD) (loss of chance if switching from an anti-TNF to abatacept)
Key Trial Info
Start Date :
November 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT05428488
Start Date
November 28 2022
End Date
November 1 2027
Last Update
October 3 2025
Active Locations (17)
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1
Centre Hospitalier Universitaire de Montpellier
Montpellier, France, France, 34295
2
CHU Bordeaux groupe Pellegrin
Bordeaux, France
3
CHU de Brest La Cavale Blanche
Brest, France
4
Centre Hospitalier de Cahors
Cahors, France