A randomized, double-blind, placebo-controlled trial of golimumab+methotrexate versus methotrexate alone in methotrexate-naïve patients with psoriatic arthritis
Phase 3
Completed
- Conditions
- psoriatic arthritisspondylartropathy1000381610023213
- Registration Number
- NL-OMON44820
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Psoriatic arthritis according to the CASPAR classification
Active disease, with a minimal of 3 swollen and tender joints
18-70 years
Exclusion Criteria
Methotrexate naive
TNF blocker naive
Concurrent and previous DMARD use
Malignancy <5 years age
active children wish, pregnancy or breast feeding
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Safety up till week 22<br /><br>- DAS remission up till week 22</p><br>
- Secondary Outcome Measures
Name Time Method <p>- EULAR DAS response at week 22<br /><br>- ACR20, ACR50 and ACR70 at week 22<br /><br>- PsARC at week 22<br /><br>- PASI75 at week 22<br /><br>- Leeds Enthesitis Index (LEI) at week 22<br /><br>- Dactylitis at week 22<br /><br>- Changes in HAQ between baseline and week 22<br /><br>- % of patients achieving low disease activity (defined as DAS <2.4) at week 22<br /><br>- % of patients achieving minimal disease activity (as defined by Coates et al,<br /><br>Ann Rheum Dis 2010) at week 22<br /><br><br /><br>Exploratory:<br /><br>- Safety up to week 50<br /><br>- EULAR response, ACR20/50/70 and PsARC at week 50<br /><br>- Survival analysis of patients remaining in DAS remission up to week 50<br /><br>- Survival analysis of patients retaining low disease activity (defined as DAS<br /><br><2.4) up to week 50<br /><br>- Survival analysis of patients retaining minimal disease activity (as defined<br /><br>by Coates et al, Ann Rheum Dis 2010) up to week 50</p><br>