Psoriatic Arthritis PsA
Conditions
Interventions
Will be put on Tofacitinib 5 mg twice daily,Will be put on Methotrexate weekly in increasing dose with maximum dose of 25 mg weekly
Experimental Drug,Active Comparator Drug
Tofacitinib 5 mg BD,Methotrexate 25 mg weekly
Sponsors
Globe Pharmaceuticals Limited
Department of Rgheumatology,
Bangabandhu Sheikh Mujib Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Male or female patients more than 18 years Psoriatic arthritis > 3 months with peripheral involvement diagnosed on the basis of CASPAR criteria Unresponsive to more than 2 NSAIDs at maximum recommended doses for more than 4 weeks, i.e 2 weeks for each NASID Patients with active disease PsA with or without extra-articular features like enthesitis, dactylitis and nail changes
Exclusion criteria
Exclusion criteria: Systemic infections requiring hospital admission during the past 6 months A history of active infectious disorders (including active or latent tuberculosis), and/or a history of chronic or recurrent serious infective diseases, opportunistic infections Hemoglobin (Hb) upper limit of normal reference range GFR less than 50 mL/min Alanine aminotransaminase (ALT) more than 2 times of ULN Pregnant or breast feeding, females of child-bearing potential not using highly effective contraception New York Heart Association Class III and IV congestive heart failure 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 Any lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR-20 response at 1, 3 and 6 months Yes/no | — |
Secondary
| Measure | Time frame |
|---|---|
| ASDAS-CRP at 1, 3 and 6 months Numerical,DAPSA at 1, 3 and 6 months Numerical,DAS 28- ESR at 1, 3 and 6 months Numerical,HAQ-DI at 1, 3 and 6 months Numerical,PASI score at 1, 3 and 6 months Numerical,MASES at 1, 3 and 6 months Numerical | — |
Countries
Bangladesh
Contacts
Public ContactPrayush Sharma
Bangabandhu Sheikh Mujib Medical University
Outcome results
None listed