Health Condition 1: M07- Enteropathic arthropathies
Conditions
Interventions
Intervention1: Apremilast: Apremilast starting at dose of 10 mg daily 0rally and increasing the dose by 10 mg daily starting from day 2 to 30 mg twice daily orally . Total duration of study period is
Sponsors
No sponsor
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years. 2. Meet the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at time of screening. 3. Have >= 2 swollen AND >= 2 tender joints at randomization. 4. Consenting to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Has received study drugs (methotrexate/apremilast) in last 3 months. 2. Has received any biological DMARDs (TNFi, IL-12/23 inhibitor, IL-17 inhibitor, CTLA4-Ig) or, other small molecules (JAK inhibitors) ever. 3. Recent initiation or a change in the dose of any DMARD in last 3 months prior to randomization. 4. Oral steroid dose more than 10 mg/day of prednisolone or equivalent. 5. Renal dysfunction (serum creatinine >1.5mg/dl) 6. Liver function abnormality (SGOT and SGPT >2 times upper limit of normal and/or total bilirubin >2mg/dl) 7. Presence of anaemia (haemoglobin 8. Presence of comorbid illnesses like major psychiatric disorders, chronic liver disease, cardiac disease, respiratory illness and illicit substance abuse which will hamper the participation of the subject in the study. 9. Pregnant or breast-feeding females. 10. Females of child bearing potential, not willing to use contraception during study period. 11. History of allergy to any component of the study drugs. 12. Hepatitis B, Hepatitis C, Human Immunodeficiency Virus (HIV) screening test positivity. 13. Presence of active infections, either bacterial, fungal or viral, at randomization or within the last 4 weeks prior to randomization. 14. Evidence of active tuberculosis at randomization. 15. Active malignancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare proportions of subjects achieving major cDAPSA response at week 24 between methotrexate and apremilast groupsTimepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. ACR 20 at 24 weeks 2. To compare PASI score at 24 weeks 3. Enthesitis score at 24 weeks 4.To compare change in dactylitis score (Leeds dactylitis index) at week 24 between two groups. 5. HAQ DI score at 24 weeks 6. Adverse event profile Timepoint: 16 weeks and 24 weeks | — |
Countries
India
Contacts
Public ContactJoydeep Samanta
PGIMER, Chandigarh
Outcome results
None listed