comparison between methotrexate versus methotrexate plus leflunomide treatment in arthritis associated with psoriasis
Phase 4
- Conditions
- Health Condition 1: L405- Arthropathic psoriasisHealth Condition 2: M138- Other specified arthritisHealth Condition 3: null- Psoriatic arthritis
- Registration Number
- CTRI/2017/06/008888
- Lead Sponsor
- JIPMER intramural fund
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patients satisfying CASPAR criteria for Psoriatic Arthritis
2. At least 3 peripheral joints with active arthritis
3. DMARD naïve patients
Exclusion Criteria
1. End stage disease (deformed fixed joints)
2. Contraindications to DMARD therapy (Chronic alcoholism, chronic liver disease, evidence of acute/chronic infection, chronic kidney disease, patients with leucopenia ( <3.0Ã?109/l), thrombocytopenia ( <150Ã?109/l), AST/ALT >2Ã? upper normal value and creatinine clearance <30ml/minute )
3. Pregnant or lactating women; patients (both men and women) of reproductive age group unwilling for contraceptive use who have not completed the family
4. Psoriatic arthritis with only axial involvement
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse drug reactions and <br/ ><br>Response to treatment - by PsARC criteria <br/ ><br>Timepoint: PsARC criteria at 24 weeks of starting treatment <br/ ><br>Adverse reaction during the study
- Secondary Outcome Measures
Name Time Method a.Functional ability â?? iHAQ <br/ ><br>b.ACR 20 and ACR 50 response criteria <br/ ><br>c.PASI score <br/ ><br>d.DAPSA score <br/ ><br>e.Percentage of patients attaining MDA in each group <br/ ><br>f.Changes in serum interleukin (IL-1α), interleukin 1 β (IL-1β) , interleukin-6(IL-6) and tumor necrosis factor α(TNF-α) <br/ ><br>Timepoint: base line and 6 months