Purpose

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.


Condition Intervention Phase
Spondyloarthritis
 Drug: Adalimumab
 Phase IV

ChemIDplus related topics:   Adalimumab  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Can New Imaging- and Bio-Markers Improve the Assessment of Disease Activity and Progression and Predict Therapeutic Outcome in Spondyloarthritis Patients Receiving Adalimumab

Further study details as provided by Hvidovre University Hospital:

Study Start Date:   February 2006
Estimated Study Completion Date:   August 2008

Detailed Description:

See brief summary

  Eligibility
Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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 TNF%u03B1 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477893

Contacts
Contact: Mikkel Ostergaard, Professor     004521603865     mo@dadlnet.dk    

Locations
Denmark
King Christian X´s Hospital of Rheumatic Diseases     Recruiting
      Graasten, Denmark
      Contact: Lis S Andersen, dr.            
Department of Rheumatology, Bispebjerg University Hospital     Recruiting
      Copenhagen, Denmark
      Contact: Karsten Asmussen, Dr.            
Department of Rheumatology, Hvidovre University Hospital     Recruiting
      Copenhagen, Denmark
      Contact: Inge Juul Sørensen, Dr.            
Department of Rheumatology, Hørsholm Hospital     Recruiting
      Hørsholm, Denmark
      Contact: Jesper Nørregaard, Dr.            
Department of Rheumatology, Herlev University Hospital     Recruiting
      Copenhagen, Denmark
      Contact: Michael Sejer Hansen, Dr.            
Department of Rheumatology, Gentofte University Hospital     Recruiting
      Copenhagen, Denmark
      Contact: Hanne Slott Jensen, Dr.            
Department of Radiology, Vejle Hospital,     Recruiting
      Vejle, Denmark
      Contact: Thomas Skjødt, Dr.            
Department of Rheumatology, Glostrup University Hospital     Recruiting
      Copenhagen, Denmark
      Contact: Gorm Thamsborg, Dr.            
Department of Rheumatology, Slagelse Hospital     Recruiting
      Slagelse, Denmark
      Contact: Torben Grube Christensen, Dr.            
Department of Radiology, Herlev University Hospital     Recruiting
      Copenhagen, Denmark
      Contact: Maria Hasselquist, Dr.            
Department of Radiology, Århus University Hospital     Recruiting
      Århus, Denmark
      Contact: Anne Grethe Jurik, Dr.            
Department of Radiology, Aabenraa Hospital     Recruiting
      Aabenraa, Denmark
      Contact: Dorrit Mikkelsen, Dr.            
Department of Rheumatology, Vejle Hospital     Recruiting
      Vejle, Denmark
      Contact: Anne Gitte Loft, Dr.            

Sponsors and Collaborators
Hvidovre University Hospital
Abbott

Investigators
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    
Contact: Mikkel Ostergaard, Professor     004521603865     mo@dadlnet.dk    
Denmark
King Christian X´s Hospital of Rheumatic Diseases     Recruiting
      Graasten, Denmark
      Contact: Lis S Andersen, dr.            
Department of Rheumatology, Bispebjerg University Hospital     Recruiting
      Copenhagen, Denmark
      Contact: Karsten Asmussen, Dr.            
Department of Rheumatology, Hvidovre University Hospital     Recruiting
      Copenhagen, Denmark
      Contact: Inge Juul Sørensen, Dr.            
Department of Rheumatology, Hørsholm Hospital     Recruiting
      Hørsholm, Denmark
      Contact: Jesper Nørregaard, Dr.            
Department of Rheumatology, Herlev University Hospital     Recruiting
      Copenhagen, Denmark
      Contact: Michael Sejer Hansen, Dr.            
Department of Rheumatology, Gentofte University Hospital     Recruiting
      Copenhagen, Denmark
      Contact: Hanne Slott Jensen, Dr.            
Department of Radiology, Vejle Hospital,     Recruiting
      Vejle, Denmark
      Contact: Thomas Skjødt, Dr.            
Department of Rheumatology, Glostrup University Hospital     Recruiting
      Copenhagen, Denmark
      Contact: Gorm Thamsborg, Dr.            
Department of Rheumatology, Slagelse Hospital     Recruiting
      Slagelse, Denmark
      Contact: Torben Grube Christensen, Dr.            
Department of Radiology, Herlev University Hospital     Recruiting
      Copenhagen, Denmark
      Contact: Maria Hasselquist, Dr.            
Department of Radiology, Århus University Hospital     Recruiting
      Århus, Denmark
      Contact: Anne Grethe Jurik, Dr.            
Department of Radiology, Aabenraa Hospital     Recruiting
      Aabenraa, Denmark
      Contact: Dorrit Mikkelsen, Dr.            
Department of Rheumatology, Vejle Hospital     Recruiting
      Vejle, Denmark
      Contact: Anne Gitte Loft, Dr.            
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    
  More Information

Study ID Numbers:   HUM 04-078
First Received:   May 23, 2007
Last Updated:   May 23, 2007
ClinicalTrials.gov Identifier:   NCT00477893
Health Authority:   Denmark: The Danish National Committee on Biomedical Research Ethics;   Denmark: Danish Medicines Agency

Study placed in the following topic categories:
Spinal Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Disease Progression
Adalimumab
Bone Diseases
Spondylarthritis

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Spondylarthritis
Therapeutic Uses
Antirheumatic Agents
Pharmacologic Actions

Source: National Library of Medicine (NLM) July 07, 2008

  


 
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