Comparison of sulfasalazine and leflunomide based combination therapies in patients with psoriatic arthritis who failed to achieve adequate response with methotrexate monotherapy

Not Applicable

Conditions: Health Condition 1: M138- Other specified arthritis

Registration Number: CTRI/2019/10/021776

Lead Sponsor: Intramural Grant from Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1)Age >18 years satisfying CASPAR classification criteria for PsA

2)At least 3 peripheral joints with active arthritis at the initiation of treatment with methotrexate monotherapy

3)Patients who have failed to respond (didnâ??t achieve MDA, patients were characterized achieving MDA if they achieve 5 of 7 criteria- tender joint count <=1; swollen joint count <=1; Psoriasis Activity and Severity Index (PASI) <=1; patient pain visual analogue score (VAS) <=15 mm; patient global disease activity VAS <=20 mm; health assessment questionnaire score <=0Â·5; and <=1 tender entheseal points )to stable dose (25 mg or maximum tolerable dose) of methotrexate monotherapy for minimum of 6 weeks.

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 >2 times of upper normal value and creatinine clearance <30ml/minute)

3)Pregnant, lactating women and patients (both men and women) of reproductive age group unwilling for contraceptive use who have not completed the family

c)Withdrawal criteria:

1)Serious infections

2)Not tolerating the medications

3)Creatinine level above the normal value

4)SGOT or SGPT more than 3 times of normal values

5)Thrombocytopenia (less than 1 lac)

6)Leucopenia (less than 3000)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response to treatment - PsARCTimepoint: At 12 weeks

Secondary Outcome Measures

Name	Time	Method
1.Change in functional ability (Indian Health Assessment Questionnaire; iHAQ) at the end of 12 weeks of therapy. <br/ ><br>2.Proportion of patients achieving ACR 20 and ACR 50 response at 12 weeks. <br/ ><br>3.PASI response at the end of 12 weeks. <br/ ><br>4.DAPSA response at the end of 12 weeks. <br/ ><br>5.Percentage of patients reaching MDA in each group. <br/ ><br>6.Safety of study medications.Timepoint: 12 weeks