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:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-25 @ 3:18 AM
NCT ID:
NCT01609205
Eligibility Criteria:
Inclusion Criteria:
* Adult patient (\> 18 years of age), male or female
* Rheumatoid arthritis according to the 1987 ACR or 2010 EULAR/ACR classification criteria
* Moderate to high disease activity
* Ongoing anti-rheumatic treatment with DMARD, with stable dosage during the last 3 months, and being a candidate for anti-TNF add-on therapy OR ongoing treatment with first anti-TNF therapy and being a candidate for switch to another anti-TNF therapy
* Women with child-bearing potential: use of an adequate method of contraception to avoid pregnancy throughout the study
* Signed Informed Consent \*Signed Informed Consent must be obtained before any study specific procedures take place.
Exclusion Criteria:
* Biologic treatment with Adalimumab before inclusion
* Two or more ongoing biologic treatments before inclusion
* Treatment with other biologic treatment than anti-TNF therapy before inclusion
* Any contraindication for treatment with Adalimumab
* Intraarticular corticosteroid injection during the last 4 weeks before each follow-up visit
* Positive for tuberculosis or hepatitis B.
* Ongoing pregnancy or lactation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01609205
Study Brief:
Protocol Section:
NCT01609205