Health Condition 1: M138- Other specified arthritis
Conditions
Interventions
Intervention1: Methotrexate and Sulfasalazine combination therapy
: Tab. sulfasalazine 500 mg orally once a day for 1 week,
twice a day for 1 week
thrice a day for 1 week and
1 gm twice daily for re
Sponsors
Intramural Grant from Institute
Eligibility
Inclusion criteria
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 <=0·5; and <=1 tender entheseal points )to stable dose (25 mg or maximum tolerable dose) of methotrexate monotherapy for minimum of 6 weeks.
Exclusion criteria
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 ( 2 times of upper normal value and creatinine clearance 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response to treatment - PsARCTimepoint: At 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in functional ability (Indian Health Assessment Questionnaire; iHAQ) at the end of 12 weeks of therapy. 2. Proportion of patients achieving ACR 20 and ACR 50 response at 12 weeks. 3. PASI response at the end of 12 weeks. 4. DAPSA response at the end of 12 weeks. 5. Percentage of patients reaching MDA in each group. 6. Safety of study medications.Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Manoj Kumar
Jawaharlal Institute Of Postgraduate Medical Education & Research (JIPMER)
Outcome results
None listed