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TNFalfa Blocking Treatment of Spondylarthropathies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00133315
Recruitment Status : Completed
First Posted : August 23, 2005
Last Update Posted : April 10, 2007
Information provided by:
Hvidovre University Hospital

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

Condition or disease Intervention/treatment Phase
Spondylarthropathies Ankylosing Spondylitis Psoriatic Arthritis Drug: Infliximab Drug: Etanercept Drug: Adalimumab Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TNFalfa Blocking Treatment of Spondylarthropathies - A Danish Multicenter Study of New Methods for Better Monitoring and Prognostifying Patients With Spondylarthropathies
Study Start Date : September 2004
Actual Study Completion Date : April 2007

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00133315

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Copenhagen, Denmark, 2100
Bispebjerg Hospital
Copenhagen, Denmark, 2400
Gentofte Hospital
Gentofte, Denmark, 2900
Glostrup Hospital
Glostrup, Denmark, 2600
Graasten Gighospital
Graasten, Denmark, 6300
Herlev Hospital
Herlev, Denmark, 2730
Horsens Sygehus
Horsens, Denmark, 8700
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Vejle Sygehus
Vejle, Denmark, 7100
Sponsors and Collaborators
Hvidovre University Hospital
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Principal Investigator: Inge Juul Soerensen, MD, Ph.D Hvidovre University Hospital, Dept. of Rheumatology
Publications automatically indexed to this study by Identifier (NCT Number):

Layout table for additonal information Identifier: NCT00133315    
Other Study ID Numbers: 232-001
KF 02-050/04
First Posted: August 23, 2005    Key Record Dates
Last Update Posted: April 10, 2007
Last Verified: April 2007
Additional relevant MeSH terms:
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Arthritis, Psoriatic
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Bone Diseases, Infectious
Bone Diseases
Spinal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Immunosuppressive Agents