Danish Multicenter Study of Adalimumab in Spondyloarthritis
DANISH
Can New Imaging- and Bio-markers Improve the Assessment of Disease Activity and Progression and Predict Therapeutic Outcome in Spondyloarthritis Patients Receiving Adalimumab
1 other identifier
interventional
52
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2006
Longer than P75 for phase_4
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 23, 2007
CompletedFirst Posted
Study publicly available on registry
May 24, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedMarch 28, 2012
March 1, 2012
2.9 years
May 23, 2007
March 27, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction in BASDAI of 20 mm or 50%
12-24 weeks of treatment
Study Arms (2)
Placebo
PLACEBO COMPARATORAdalimumab
ACTIVE COMPARATORInterventions
sc. injection Humira 40 mg every other week, from week 0 or 12 to the end of study
Eligibility Criteria
You may qualify if:
- Diagnosis of spondyloarthritis according to the European Spondyloarthritis Study Group (ESSG) criteria
- Clinical active disease, defined as a BASDAI score \> 4 despite concurrent NSAID therapy
- Presence of sacroiliitis on conventional radiography or MRI.
- Among other issues: Age \>18 years; adequate birth control; no contraindications for anti-TNFa-therapy, no previous TNFa-antagonists
You may not qualify if:
- Previous TNFα inhibitor therapy
- Treatment with disease modifying anti-rheumatic drugs within 4 weeks before screening
- Oral, intraarticular, intramuscular or intravenous glucocorticoid within 4 weeks before screening
- Pregnancy or lactation
- HIV, hepatitis B or C, tuberculosis, other infections
- Malignancies
- Other serious concomitant diseases (uncontrolled/severe kidney, liver, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological ore cerebral disease (including demyelinating disease)
- Contraindications to anti-TNFa-therapy
- Contraindications to MRI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glostrup University Hospital, Copenhagenlead
- Abbottcollaborator
Study Sites (13)
Department of Radiology, Aabenraa Hospital
Aabenraa, Denmark
Department of Radiology, Århus University Hospital
Aarhus, 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
Gråsten, 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
Related Publications (1)
Pedersen SJ, Poddubnyy D, Sorensen IJ, Loft AG, Hindrup JS, Thamsborg G, Asmussen K, Hendricks O, Norregaard J, Piil AD, Moller JM, Jurik AG, Balding L, Lambert RG, Sieper J, Ostergaard M. Course of Magnetic Resonance Imaging-Detected Inflammation and Structural Lesions in the Sacroiliac Joints of Patients in the Randomized, Double-Blind, Placebo-Controlled Danish Multicenter Study of Adalimumab in Spondyloarthritis, as Assessed by the Berlin and Spondyloarthritis Research Consortium of Canada Methods. Arthritis Rheumatol. 2016 Feb;68(2):418-29. doi: 10.1002/art.39434.
PMID: 26414004DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 23, 2007
First Posted
May 24, 2007
Study Start
February 1, 2006
Primary Completion
January 1, 2009
Study Completion
January 1, 2013
Last Updated
March 28, 2012
Record last verified: 2012-03