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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Page 1 of 3 (9 locations)

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