Phase 3 Rheumatoid Arthritis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 or older
• People who have been diagnosed with rheumatoid arthritis according to the 2010 ACR-EULAR classification criteria
• People who test positive for ACPA (a specific antibody associated with rheumatoid arthritis)
• People who have been taking methotrexate or leflunomide for at least 3 months
• People whose disease activity score (DAS28-CRP) is above 3.2 while on methotrexate or leflunomide, measured using a blood test taken within 7 days of the study start
• People who have shown signs that their current treatment is not controlling the disease well enough, based on elevated inflammation markers in blood tests (CRP or ESR) within the last 6 months before the study start
• People who have never previously been treated with biological or targeted synthetic DMARDs (a category of more advanced arthritis medicines)
• People for whom a doctor has determined that a TNF inhibitor (a type of advanced arthritis medicine) is appropriate

Who may not be able to join:

• People who are unable to read or write
• People who have plans to travel away from the area for an extended period that would prevent them from attending required study visits
• People who are unable to sign a consent form
• People who are not covered by public health insurance in France
• People who have dementia
• People who have fibromyalgia
• People who have medical reasons that make TNF inhibitors or Abatacept unsuitable for them
• People who have not had a tuberculosis screening test in the 3 months before the study start
• People who have active, untreated tuberculosis
• People who cannot commit to being followed up for 48 weeks
• People with a current drug or alcohol addiction
• People in certain protected categories under the French Public Health Code, such as pregnant, recently given birth, or breastfeeding women, prisoners, or adults under legal guardianship
• Women who are capable of becoming pregnant and are not using an effective method of contraception
• People who are under a legal protection order
• Prisoners
• People who are employed by or financially dependent on the study sponsor or investigator
• People who have participated in another interventional clinical trial or received an investigational drug within the 4 weeks before screening
• People with moderate to severe heart failure (classified as Class 3 or Class 4 by the New York Heart Association)
• People who have a history of chronic obstructive pulmonary disease (COPD) and are heavy smokers
• People who have a surgical procedure planned within at least 30 days before the screening date (confirm with trial site)
• People with a known allergy or intolerance to anti-TNF therapy
• People with a known allergy or sensitivity to Abatacept or any of its ingredients
• People who have active, untreated hepatitis B
• People who have received a live vaccine within 30 days before screening
• People who have an inflammatory bowel disease (such as Crohn's disease or ulcerative colitis)

Important: Always verify eligibility with the trial site directly before applying.