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Danish Multicenter Study of Adalimumab in Spondyloarthritis (DANISH)

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: NCT00477893
Recruitment Status : Unknown
Verified March 2012 by MOstergaard, Glostrup University Hospital, Copenhagen.
Recruitment status was:  Active, not recruiting
First Posted : May 24, 2007
Last Update Posted : March 28, 2012
Information provided by (Responsible Party):
MOstergaard, Glostrup University Hospital, Copenhagen

Brief Summary:
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 or disease Intervention/treatment Phase
Spondyloarthritis Drug: Adalimumab Drug: Placebo Phase 4

Detailed Description:
See brief summary

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2006
Actual Primary Completion Date : January 2009
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Reduction in BASDAI of 20 mm or 50% [ Time Frame: 12-24 weeks of treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00477893

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Department of Radiology, Aabenraa Hospital
Aabenraa, Denmark
Department of Radiology, Herlev University Hospital
Copenhagen, Denmark
Department of Rheumatology, Bispebjerg University Hospital
Copenhagen, Denmark
Department of Rheumatology, Gentofte University Hospital
Copenhagen, Denmark
Department of Rheumatology, Glostrup University Hospital
Copenhagen, Denmark
Department of Rheumatology, Herlev University Hospital
Copenhagen, Denmark
Department of Rheumatology, Hvidovre 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
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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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: MOstergaard, Professor, Glostrup University Hospital, Copenhagen Identifier: NCT00477893     History of Changes
Other Study ID Numbers: HUM 04-078
First Posted: May 24, 2007    Key Record Dates
Last Update Posted: March 28, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
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Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Joint Diseases
Anti-Inflammatory Agents
Antirheumatic Agents