NL-OMON36697
Completed
Phase 2
Prevention of the progression of very early symptoms into ankylosing spondylitis - PREVAS
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- ankylosing spondylitis
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 80
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients to be included must meet the following criteria.
- •\- age \* 18 years,
- •\- patient with inflammatory back pain for at least 3 months, with onset \< 45 years
- •\- presence of ³2 SpA\-features or
- •\- presence of ³1 SpA\-feature with HLA\-B27 positivity or two family members with definite AS (1e or 2e degree family\-member);
- •\- no definite sacroiliitis on the X\-ray (sacroiliitis grade 1 is sustained);
- •\- BASDAI score of \* 4 (0\-10\)
- •\- Insufficient response to treatment with NSAID's over a 4\-week period
Exclusion Criteria
- •\- definite AS (modified New York criteria (9\);
- •\- previous treatment with TNF\-blockers.
- •General medical exclusion criteria: for treatnebt with TNF blockers (pregnancy or planning pregnancy, infections, tuberculosis, HIV, Hepatitis B or C, malignincies etc)
Outcomes
Primary Outcomes
Not specified
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