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TNFalfa Blocking Treatment of Spondylarthropathies

This study has been completed.
Information provided by:
Hvidovre University Hospital Identifier:
First received: August 22, 2005
Last updated: April 9, 2007
Last verified: April 2007

August 22, 2005
April 9, 2007
September 2004
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Complete list of historical versions of study NCT00133315 on Archive Site
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TNFalfa Blocking Treatment of Spondylarthropathies
TNFalfa Blocking Treatment of Spondylarthropathies - A Danish Multicenter Study of New Methods for Better Monitoring and Prognostifying Patients With Spondylarthropathies

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 researchers want to identify better biomarkers for disease activity and disease progression. In addition, the researchers want to identify predictors for disease progression.

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Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Spondylarthropathies
  • Ankylosing Spondylitis
  • Psoriatic Arthritis
  • Drug: Infliximab
  • Drug: Etanercept
  • Drug: Adalimumab
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2007
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Inclusion Criteria:

  • 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 Criteria:

  • 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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
232-001, KF 02-050/04
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Hvidovre University Hospital
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Principal Investigator: Inge Juul Soerensen, MD, Ph.D Hvidovre University Hospital, Dept. of Rheumatology
Hvidovre University Hospital
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP