The effect of switching treatment from innovator infliximab to infliximab biosimilar on efficacy, safety and immunogenicity in patients with rheumatoid arthritis, spondyloarthritis or psoriatic arthritis in daily clinical care
Completed
- Conditions
- Biosimilar, Infliximab, Inflectra, Remsima
- Registration Number
- NL-OMON24401
- Lead Sponsor
- Participating hospitals are:Sint Maartenskliniek NijmegenMaartenskliniek WoerdenRadboud University Medical Centre NijmegenRijnstate Arnhem
- Brief Summary
https://pubmed.ncbi.nlm.nih.gov/29045077/
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1. A clinical diagnosis of either RA, SpA or PsA.
2. Currently being treated with Remicade (1 or more infusions)
3. > 18 years of age
4. Ability to read and communicate well in Dutch
5. Informed consent
Exclusion Criteria
None
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The difference in mean DAS28-ESR and mean DAS28-CRP (for RA and PsA) and mean BASDAI (for SpA) between baseline and follow-up (after 6 and 12 months of treatment with the biosimilar) will be used as primary efficacy endpoint
- Secondary Outcome Measures
Name Time Method