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 @ 11:53 AM
Ignite Modification Date:
2025-12-24 @ 11:53 AM
NCT ID:
NCT03736161
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patients more than 18 years
2. Psoriatic arthritis \> 3 months with peripheral involvement diagnosed on the basis of CASPAR criteria
3. Unresponsive to more than 2 NSAIDs at maximum recommended doses for more than 4 weeks, i.e 2 weeks for each NASID
5\. Patients with active disease 6. PsA with or without extra-articular features like enthesitis, dactylitis and nail changes
Exclusion Criteria:
1. Systemic infections requiring hospital admission during the past 6 months
2. A history of active infectious disorders (including active or latent tuberculosis), and/or a history of chronic or recurrent serious infective diseases, opportunistic infections
3. Hemoglobin (Hb) \< 9 g/dl
4. White blood cell count \< 3000, Neutrophil count \< 1000, Platelet count \< 100000
5. Live vaccines within 3 months prior to the first dose
6. Serum creatinine \> upper limit of normal reference range
7. GFR less than 50 mL/min
8. Alanine aminotransaminase (ALT) more than 2 times of ULN
9. Pregnant or breast feeding, females of child-bearing potential not using highly effective contraception
10. New York Heart Association Class III and IV congestive heart failure
11. Evidence or history of malignancy, with the exception of adequately treated or excised non-metastatic basal or squamous cell cancer of the skin or cervical carcinoma in situ
12. Any lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03736161
Study Brief:
Protocol Section:
NCT03736161