Prevention of the progression of very early symptoms into ankylosing spondylitis

Phase 2

Completed

Conditions: ankylosing spondylitis
spondyloarthritis
10023213

Registration Number: NL-OMON36697

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Disease-activity : including questionnaires (BASDAI, BASFI, BASG, pain VAS,<br /><br>ASAS core set, SF-36), measured after 1 and 3 years, physical examination<br /><br>(including BASMI and MASES), measured after 1 and 3 years and laboratory<br /><br>parameters (blood; including acute phase reactants as ESR and CRP and urine),<br /><br>measured after 1 and 3 years.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Radiographic changes of the X-SI joint en X-spine (BASRI-score), measured after<br /><br>1 and 3 years.<br /><br><br /><br>Inflammation at MRI SI-joint/spine, after 16 weeks and 6 months.</p><br>