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TNFalfa Blocking Treatment of Spondylarthropathies

This study has been completed.
Sponsor:
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00133315
First received: August 22, 2005
Last updated: April 9, 2007
Last verified: April 2007
  Purpose

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 Intervention Phase
Spondylarthropathies
Ankylosing Spondylitis
Psoriatic Arthritis
Drug: Infliximab
Drug: Etanercept
Drug: Adalimumab
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Estimated Enrollment: 50
Study Start Date: September 2004
Study Completion Date: April 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133315

Locations
Denmark
Bispebjerg Hospital
Copenhagen, Denmark, 2400
Rigshospitalet
Copenhagen, Denmark, 2100
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
Investigators
Principal Investigator: Inge Juul Soerensen, MD, Ph.D Hvidovre University Hospital, Dept. of Rheumatology
  More Information

No publications provided by Hvidovre University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00133315     History of Changes
Other Study ID Numbers: 232-001, KF 02-050/04
Study First Received: August 22, 2005
Last Updated: April 9, 2007
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Arthritis, Psoriatic
Spondylarthropathies
Spondylitis
Spondylitis, Ankylosing
Ankylosis
Arthritis
Bone Diseases
Bone Diseases, Infectious
Infection
Joint Diseases
Musculoskeletal Diseases
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthritis

ClinicalTrials.gov processed this record on November 23, 2014