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 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT01476956
Eligibility Criteria:
Inclusion Criteria (selected):
* 18 years of age or older
* RA according to the 2010 Rheumatoid Arthritis Classification Criteria
* Joint symptoms for ≥ 3 months prior to screening
* DAS44 \> 2.4
* About to start DMARD therapy (methotrexate, salazopyrin, hydroxychloroquine, chloroquine, leflunomide) or
* increased dose of methotrexate by ≥10 mg weekly to a maximum dose of 25mg weekly (if already receiving \>15mg will require add-on DMARD/anti-TNF or switch to alternative DMARD),
* add-on of alternative DMARD,
* switch to alternative DMARD,
* start of first anti-TNFα agent (adalimumab, etanercept, infliximab, certolizumab pegol, golimumab)
* If already on DMARD therapy this has been stable for the 3 months prior to the baseline visit
* If already on systemic steroid, dose must be stable (prednisone ≤ 7.5mg/day) for 1 month prior to the baseline visit
* Patient will be available for follow up for a minimum of 24 months from the baseline visit
Exclusion Criteria (selected):
* Intra-articular steroid injection within 4 weeks prior to the baseline visit
* Prior treatment with anti-TNFα or other biological agent (rituximab, abatacept, tocilizumab)
* Malignancy within past 5 years (other than basal cell carcinoma that has been adequately treated or excised, squamous cell cancer of the skin, and cervical carcinoma in situ)
* History of:
* Serious infection (defined as requiring parenteral antibiotics or hospitalization) within 3 months prior to the baseline visit;
* Active tuberculosis or history of tuberculosis without documented curative treatment and/or positive tuberculin reaction to PPD (Purified Protein Derivative)
* For patients starting anti-TNF therapy, a positive TB screening test and no record of effective prophylaxis according to local expert recommendations
* Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01476956
Study Brief:
Protocol Section:
NCT01476956