Full Text View
Tabular View
No Study Results Posted
Related Studies
Danish Multicenter Study of Adalimumab in Spondyloarthritis (DANISH)
This study is ongoing, but not recruiting participants.
Study NCT00477893   Information provided by Hvidovre University Hospital
First Received: May 23, 2007   Last Updated: August 24, 2009   History of Changes

May 23, 2007
August 24, 2009
February 2006
January 2009   (final data collection date for primary outcome measure)
Reduction in BASDAI of 20 mm or 50% [ Time Frame: 12-24 weeks of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00477893 on ClinicalTrials.gov Archive Site
 
 
 
Danish Multicenter Study of Adalimumab in Spondyloarthritis
Can New Imaging- and Bio-markers Improve the Assessment of Disease Activity and Progression and Predict Therapeutic Outcome in Spondyloarthritis Patients Receiving Adalimumab

Spondyloarthropathies (SpA) are often diagnosed with a considerable delay (often 8-10 years from symptom onset), because the available clinical, biochemical and radiological methods are not sufficiently sensitive. TNF-a antagonists have recently been introduced for treatment of SpA, and current data indicate a higher efficacy than previously available therapies. The improved treatment options have increased the need for improved methods for diagnosis, monitoring and prognostication of these diseases, so that the efficient therapies can be initiated at the optimal time point and monitored optimally. Magnetic resonance imaging (MRI) and a number of biomarkers are promising, but not yet sufficiently studied, methods for this.

See brief summary

Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Spondyloarthritis
  • Drug: Adalimumab
  • Drug: Placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
52
January 2013
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Diagnosis of spondyloarthritis according to the European Spondyloarthritis Study Group (ESSG) criteria
  2. Clinical active disease, defined as a BASDAI score > 4 despite concurrent NSAID therapy
  3. Presence of sacroiliitis on conventional radiography or MRI.
  4. Among other issues: Age >18 years; adequate birth control; no contraindications for anti-TNFa-therapy, no previous TNFa-antagonists

Exclusion Criteria:

  1. Previous TNFα inhibitor therapy
  2. Treatment with disease modifying anti-rheumatic drugs within 4 weeks before screening
  3. Oral, intraarticular, intramuscular or intravenous glucocorticoid within 4 weeks before screening
  4. Pregnancy or lactation
  5. HIV, hepatitis B or C, tuberculosis, other infections
  6. Malignancies
  7. Other serious concomitant diseases (uncontrolled/severe kidney, liver, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological ore cerebral disease (including demyelinating disease)
  8. Contraindications to anti-TNFa-therapy
  9. Contraindications to MRI
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00477893
Professor Mikkel Østergaard, Dep. of Rheumatology, Hvidovre Hospital
HUM 04-078
Hvidovre University Hospital
Abbott
Study Chair: Inge Juul Sørensen, Dr. Department of Rheumatology, Hvidovre University Hospital
Study Chair: Susanne Juhl Pedersen, Dr. Department of Rheumatology, Herlev University Hospital
Principal Investigator: Mikkel Ostergaard, Professor Department of Rheumatology, Hvidovre University Hospital
Hvidovre University Hospital
August 2009

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