Status:
COMPLETED
TNFalfa Blocking Treatment of Spondylarthropathies
Lead Sponsor:
Hvidovre University Hospital
Conditions:
Spondylarthropathies
Ankylosing Spondylitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to establish a Danish cohort of spondylarthropathy (SpA) patients who are being treated with TNFalfa blockers. By following the TNFalfa blocking treated patients the resear...
Eligibility Criteria
Inclusion
- Age\>18 years old
- Spondylarthropathies according to the European Spondylarthropathy Study Group (ESSG) criteria
- Sacroiliitis by X-ray or magnetic resonance imaging (MRI)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)\>3
- No signs of tuberculosis (TB)
- Sufficient contraception
Exclusion
- Wish of pregnancy or nursing
- Previous treatment with TNFalfa blocker
- Disease-modifying anti-rheumatic drugs (DMARDs) other than methotrexate (MTX) later than 4 weeks before inclusion
- Steroid treatment later than 4 weeks before inclusion
- Immunosuppressing agents later than 4 weeks before inclusion
- Severe infections within 3 months
- HIV-infection
- Active hepatitis B and C
- Active or latent TB
- Severe chronic diseases
- Heart insufficiency (New York Heart Association \[NYHA\] 3 and 4)
- Malignancy
- Systemic lupus erythematosus (SLE) or SLE-like disease
- Abuse of narcotics or alcohol
- Major psychiatric disorders
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00133315
Start Date
September 1 2004
End Date
April 1 2007
Last Update
April 10 2007
Active Locations (9)
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1
Rigshospitalet
Copenhagen, Denmark, 2100
2
Bispebjerg Hospital
Copenhagen, Denmark, 2400
3
Gentofte Hospital
Gentofte Municipality, Denmark, 2900
4
Glostrup Hospital
Glostrup Municipality, Denmark, 2600