Efficacy of a sequential treatment strategy in Rheumatoid Arthritis.
- Conditions
- Rheumatoid ArthritisTherapeutic area: Diseases [C] - Immune System Diseases [C20]Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- CTIS2022-500234-29-00
- Lead Sponsor
- niversity Hospital Montpellier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 220
Aged 18 years or above, Rheumatoid Arthritis according to ACR-EULAR 2010, 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 CRP (CRP> 5mg/L ) or 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
Contra-indications to a TNF inhibitor and/or Abatacept, Dementia, Fibromyalgia, Absence of tuberculosis screening in the previous 3 months before baseline, Drug addiction, addiction to alcohol, Subject with moderate to severe heart failure (class 3 or class 4 cardiac disease as defined by the New York Heart Association Functional Classification), Known allergy or intolerance to an anti-TNF therapy, Patient with untreated active hepatitis B, Patient vaccinated with a live vaccine within 30 days prior to screening
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method