Comparing Leflunomide, sulfasalazine and tofacitinib in rheumatoid arthritis patients with methotrexate inadequate response
- Conditions
- Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
- Registration Number
- CTRI/2023/07/055919
- Lead Sponsor
- Indian Rheumatology Association
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
satisfying presence of classification criteria ACR/EULAR rheumatoid arthritis classification criteria 2010, has suboptimal response to maximal tolerated dose or 25mg stable dose for at least 6 weeks to methotrexate monotherapy defined by Disease Activity Score DAS 28 CRP >3.2 at 3 months.
1 Blood dyscrasias at screening
2 Absolute white blood cell count (WBC) <3.0 x 109/L ( <3000 mm3)
3 Absolute neutrophil count (ANC) <1.5 x 109/L ( <1500 mm3)
4 Absolute lymphocyte count <1.0 x 109/L ( <1000/mm3)
5 Platelet count <100 x 109/L ( <100,000/mm3)
6 Estimated Creatinine Clearance <30 mL/min based on CKD-EPI at Screening.
7 Total bilirubin, AST or ALT more than 2 times the upper limit of normal (ULN) at screening
8 Patients having active tuberculosis or positive for latent tuberculosis as tested by QuantiFERON-TB Gold In Tube (QFT Gold test) or Montoux skin Test.
•History of recurrent herpes zoster or herpes simplex.
•History of lymphoproliferative disorder.
•Present malignancy or with a history of malignancy
•Pregnant female or breast feeding mothers.
•History of Sulfa drug allergy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method