Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-24 @ 11:53 AM
NCT ID:
NCT03649061
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years and older
* Diagnosis of RA as defined by the American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) 2010 criteria for early RA
* Early RA defined by a diagnosis made ≤ 1 year ago.
* Use a reliable method of contraception for women of childbearing potential to be evaluated as in daily clinical practice
* Able and willing to give written informed consent and to participate in the study
* Understanding and able to write Dutch or French
Exclusion Criteria:
* Previous treatment with:
* Methotrexate (MTX) or leflunomide
* cyclophosphamide, azathioprine or cyclosporine
* sulphasalazine (SSZ) for more than 3 weeks
* hydroxychloroquine for more than 6 weeks
* oral Glucocorticoids (GC) for more than 4 weeks within 4 months before screening
* oral GC at a daily dosage of more than 10 mg prednisone equivalent within 4 weeks before baseline
* oral GC at a daily dosage equal to or less than 10 mg prednisone equivalent within 2 weeks before baseline
* intra-articular GC within 4 weeks before BL
* an investigational drug for the treatment/prevention of RA
* History of chronic heart failure
* History of severe infections or chronic infection
* History of malignant neoplasm within 5 years
* Contra indications for GC
* Contra indications for TNF blocking agents
* Contra indications for MTX or leflunomide
* Psoriatic Arthritis
* Underlying cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency which in the opinion of the investigator places the patient at an unacceptable risk for participation in the study
* Pregnancy, breastfeeding or no use of a reliable method of contraception for woman of childbearing potential (as in daily clinical practice)
* Alcohol or drug abuse
* Active tuberculosis (TB)
* Latent TB unless adequate prophylactic treatment is given according to local guidelines
* No access to the Belgian Health Insurance system-
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03649061
Study Brief:
Protocol Section:
NCT03649061