Danish Multicenter Study of Adalimumab in Spondyloarthritis (DANISH)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Glostrup University Hospital, Copenhagen.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
MOstergaard, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT00477893
First received: May 23, 2007
Last updated: March 27, 2012
Last verified: March 2012
  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
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • Reduction in BASDAI of 20 mm or 50% [ Time Frame: 12-24 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: February 2006
Estimated Study Completion Date: January 2013
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
sc. inj. placebo every other week, week 0, 2, 4, 6, 8, and 10.
Active Comparator: Adalimumab Drug: Adalimumab
sc. injection Humira 40 mg every other week, from week 0 or 12 to the end of study

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 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
  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: NCT00477893

Locations
Denmark
Department of Radiology, Aabenraa Hospital
Aabenraa, Denmark
Department of Rheumatology, Bispebjerg University Hospital
Copenhagen, Denmark
Department of Rheumatology, Hvidovre University Hospital
Copenhagen, Denmark
Department of Radiology, Herlev University Hospital
Copenhagen, Denmark
Department of Rheumatology, Herlev University Hospital
Copenhagen, Denmark
Department of Rheumatology, Gentofte University Hospital
Copenhagen, Denmark
Department of Rheumatology, Glostrup University Hospital
Copenhagen, Denmark
King Christian X´s Hospital of Rheumatic Diseases
Graasten, Denmark
Department of Rheumatology, Hørsholm Hospital
Hørsholm, Denmark
Department of Rheumatology, Slagelse Hospital
Slagelse, Denmark
Department of Radiology, Vejle Hospital,
Vejle, Denmark
Department of Rheumatology, Vejle Hospital
Vejle, Denmark
Department of Radiology, Århus University Hospital
Århus, Denmark
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Abbott
Investigators
Study Chair: Inge Juul Sørensen, Dr. Department of Rheumatology, Glostrup University Hospital
Study Chair: Susanne Juhl Pedersen, Dr. Department of Rheumatology, Glostrup University Hospital
Principal Investigator: Mikkel Ostergaard, Professor Department of Rheumatology, Glostrup University Hospital
  More Information

No publications provided

Responsible Party: MOstergaard, Professor, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT00477893     History of Changes
Other Study ID Numbers: HUM 04-078
Study First Received: May 23, 2007
Last Updated: March 27, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 28, 2014