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 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
NCT ID:
NCT00686868
Eligibility Criteria:
Key Inclusion Criteria:
* Male or female aged ≥ 18 years
* A diagnosis of rheumatoid arthritis according to the American College of Rheumatology (ACR1987 classification) of at least six months prior to screening
* Subjects must be treated with MTX, 7.5-25 mg/week, for at least 12 weeks prior to Visit 2, with the last 4 weeks prior to Day 2 at a stable dosage
* Patient must be willing to receive folic acid ≥5mg/wk 4 weeks prior to baseline administered according to locally accepted practice
* Body mass index (BMI) \< 35kg/m2 (inclusive)
* Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Key Exclusion Criteria:
* Subjects with a history of a rheumatic autoimmune disease other than RA (except secondary Sjögren's syndrome), or with significant systemic involvement secondary to RA (vasculitis, pulmonary fibrosis or Felty's syndrome)
* Previous exposure to biologic cell depleting anti-rheumatic therapies, including investigational compounds (e.g. anti-CD11a, anti-CD19, anti-CD20, anti-CD22, anti-BLyS/BAFF, anti-CD3, anti-CD4, anti-CD5, anti-CD52)
* Exposure to etanercept \< 4 weeks, infliximab or adalimumab \< 8 weeks, or abatacept or anakinra \< 12 weeks prior to visit 2
* Received any of the following treatments within 4 weeks prior to Visit 2:
* Anti-cancer therapy (e.g. alkylating agents, anti-metabolites, purine analogues, monoclonal antibodies)
* Glucocorticoid unless given in doses equivalent to ≤ 10 mg of prednisolone /day
* Intra-articular, i.m. or IV corticosteroids
* Live/attenuated vaccinations
* Cyclosporine
* Azathioprine
* Penicillamine
* Sulfasalazine
* Bucillamine
* Hydroxychloroquine
* Chloroquine
* Exposure to leflunomide within 12 weeks prior to visit 2 unless the subject has completed peroral cholestyramine treatment
* Exposure to gold therapy ≤ 12 weeks prior to Visit 2
* Exposure to IV immunogammaglobulins ≤ 24 weeks prior to Visit 2
* Past or current malignant melanoma
* Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, renal infection, chest infection with bronchiectasis, tuberculosis and active hepatitis B and C
* History of significant cerebrovascular disease
* Positive plasma / white cell JC Virus (JCV) PCR (either compartment)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00686868
Study Brief:
Protocol Section:
NCT00686868