Methotrexate and leflunomide combination therapy in psoriatic arthritis
Completed
- Conditions
- Psoriatic arthritis Artritis psoriatica
- Registration Number
- NL-OMON21424
- Lead Sponsor
- St Maartenskliniek, Nijmegen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 78
Inclusion Criteria
Adult male or female
-Age ≥16 years
Exclusion Criteria
-Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or for approximately 2 years after the last dose of study drug or up to 11 days after treatment when washout procedure is executed.
-Male subject who is considering fathering a child or donating sperm during the study or for approximately 2 years after the last dose of study drug or up to 11 days after treatment when washout procedure is executed.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint is the difference in efficacy between monotherapy MTX and combination therapy MTX plus LEF on the Psoriatic Arthritis Disease Activity Score (PASDAS) at 16 weeks.
- Secondary Outcome Measures
Name Time Method Key secondary parameters are: change in skin score, enthesitis score, dactylitis score and swollen/tender joint count. Furthermore, the difference in immunoprofile, treatment failure, and the percentage of (S)AE’s between the two groups will be assessed.