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 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT01481493
Eligibility Criteria:
Inclusion Criteria:
* Patients with active Rheumatoid Arthritis (RA) according to 1987 revised ACR criteria with functional class II-III
* Disease activity at screening and baseline (more than 6 swollen joint count; more than 6 tender joint count; elevat. of CRP or ESR)
* Duration of RA more than 12 month
* History of at least one disease-modifying anti-rheumatic drug (DMARD) with an inadequate response despite more than 3 month of treatment
* MTX treatment at least 6 month with a stable dose at least 15mg MTX
* Patients could continue at more than daily 7,5mg of prednisone or equivalent stable dose at least 6 weeks prior baseline
* Written Informed Consent
Exclusion Criteria:
* Treatment with traditional DMARDs apart from MTX 12 weeks prior to baseline and DMARD leflunomide 24 weeks
* Treatment with any biologics other than TNF-α inhibitors (e.g. abatacept, rituximab, tocilizumab, anakinra)
* treatment with any TNF-α inhibitor within 5 elimination half-lives prior baseline and during the study
* Clinical non-response to more than one of TNF-α inhibitor exceeding adequate treatment duration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01481493
Study Brief:
Protocol Section:
NCT01481493