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 @ 5:30 PM
Ignite Modification Date:
2025-12-24 @ 5:30 PM
NCT ID:
NCT01724268
Eligibility Criteria:
Inclusion Criteria:
1. Males or females aged 18 years or older.
2. Satisfies the 2010 American College of Rheumatology/European League Against Rheumatism Criteria for Rheumatoid Arthritis.
3. Rheumatoid arthritis of \< 2 years duration
4. Has active disease at the time of enrollment. (Modified Disease Activity Score ≥ 3.2)
5. Demonstrates functional status of class I, II, or III as defined by American College of Rheumatology revised criteria.
6. Is on methotrexate 25 mg weekly or the maximum tolerated dose, therapy should be for at least 3 months duration and on the highest tolerated dose for the last 4 weeks.
7. Is able and willing to self-inject study drug if assigned to the injectable drug group or have a designee who can do so.
8. Is PPD negative (skin test for TB exposure) or completed ≥1 month of latent TB treatment if PPD ≥ 5 or quantiferon (blood test for TB exposure) positive.
9. Is having normal Chest X-Ray.
10. Is Hepatitis B Negative.
11. Not on NSAID (e.g. Ibuprofen) or receiving the same dose of the same NSAID throughout the study period unless side effects occur
12. All patients in childbearing age should use effective birth control methods
13. Is capable of understanding and signing an informed consent form.
Exclusion Criteria:
1. Received any previous treatment with Tumor Necrosis Factor inhibitor or other biologic treatments for Rheumatoid Arthritis (such as abatacept, rituximab, tocilizumab, or Anakinra).
2. Received any previous treatment with oral corticosteroids (e.g. prednisolone)
3. Has a known or expected allergy, contraindication, or hypersensitivity to the medications tested.
4. Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in, and completion of, the study, or could preclude the evaluation of the subject's response.
5. Received any of the following within 4 weeks before baseline visit: leflunomide, hydroxychloroquine, chloroquine, cyclosporine, sulphasalazine, auranofin, intramuscular gold, azathioprine, minocycline, or D-penicillamine
6. Received cyclophosphamide within 6mths before screening visit.
7. Received any live (attenuated) vaccines within 4 weeks before screening visit.
8. Received intra-articular or subcutaneous corticosteroid injection within 4 weeks before screening visit.
9. Received bolus intramuscular/ intravenous treatment with corticosteroids (\> 20mg prednisone or equivalent) within 4 weeks before screening visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01724268
Study Brief:
Protocol Section:
NCT01724268