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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT02221258
Eligibility Criteria:
Inclusion Criteria:
1. of either gender, 19-80years old
2. Subjects must be diagnosed with ACR functional class I. II, III Rheumatoid Arthritis according to the 2010 ACR/EULAR criteria for at least 12 weeks duration.
3. Subjects must be taking DMARDs or NSAIDs including methotrexate, sulfasalazine, hydroxychloroquine, leflunomide of stable dose within 12 weeks before screening visit and be willing to remain on stable dose throughout the study
4. If subject is currently administering steroids everyday, when steroid dose is converted into prednisolone oral dose, the subject should take a stable dose(≤10mg/day) over 4 weeks on screening visit
5. Subject who has moderate to severe disease activity (DAS28-ESR\>3.2) on screening visit
6. Subject who understands and voluntarily sign an informed consent form
Exclusion Criteria:
1. Subjects who is diagnosed ACR function class IV Rheumatoid Arthritis
2. Subjects who has cardiovascular disorders, blood dyscrasia, AIDS(Acquired Immune Deficiency Syndrome), other rheumatic disease(Crohn's disease, systemic lupus erythematosus, lyme disease, psoriatic arthritis, spondylarthropathy, infectious or reactive arthritis, reiter's syndrome, etc.)
3. subject who has administered the following biological DMARDs
* subject who has administered more than 1 drugs(Infliximab, Adalimumab, Etanercept, Anakinra, Abatacept) within 6 months before screening visit
* subject who has administered Rituximab within 1 year before screening visit
4. Subject who has history of hypersensitivity, heavy metal poisoning, etc. to drugs which is composed of similar components.
5. Subject who has treated intra-articular steroid injection within 4 weeks before screening visit
6. Subject who has administered ACTH(adrenocorticotropic hormone) agents within 4 weeks before screening visit
7. Subject who has undergone administration of any investigational drug within 30 days before screening visit.
8. Subject who has diseases or takes medicine which are prohibited prescription of NSAIDs.
9. Subject who needs to take the medicine which is prohibited to take at the same time
10. Pregnant, breast-feeding women
11. Subject who has sever dyshepatia (Serum creatinine level ≥ 1.7mg/dl)
12. Subject who has severe renal dysfunction (ALT/AST/bilirubin value ≥ 2 upper limit of the normal range at screening test)
13. Any other condition which the PI Judges would make patient unsuitable for study participation
14. Subject who experienced stem cell therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
80 Years
Study:
NCT02221258
Study Brief:
Protocol Section:
NCT02221258