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 @ 2:27 PM
Ignite Modification Date:
2025-12-24 @ 2:27 PM
NCT ID:
NCT00209859
Eligibility Criteria:
Inclusion Criteria:
* Synovitis in at least 2 joints.
* Compliance with the ACR criteria for RA.
* Duration of no more than 6 months (from the first anamnestic non-traumatic synovitis of at least 6 weeks' duration).
* Informed consent.
Exclusion Criteria:
* Age less than 18 years or more than 75 years
* Lack of co-operability.
* Previous treatment with DMARD
* Corticosteroid treatment during the preceding 4 weeks.
* Contra indications for the treatments (awaiting the recommendations from Novartis)
* Previous or present malignant or premalignant disease
* Poorly regulated hypertension
* Impaired renal function
* Immuno defective diseases, including HIV
* Cardiac or pulmonary insufficiency
* Serious arteriosclerosis
* Serious granulocytopenia or thrombocytopenia
* Impaired liver function (liver enzymes more than twice the highest normal limit).
* Alcohol consumption of more than 3 drinks a week.
* Poorly controlled epilepsy
* Lack of contraception in fertile patients
* Pregnancy and lactation
* Psoriasis
* Poorly regulated diabetes
* Anticoagulant treatment
* Known allergy to the medicine
* Medicamental interactions
* Other inflammatory rheumatic diseases
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00209859
Study Brief:
Protocol Section:
NCT00209859