Clinical trial NCT00477893: Danish Multicenter Study of Adalimumab in Spondyloarthritis
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Spondyloarthritis
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2007-05-24
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: See brief summary

Eligibility 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

Primary outcomes:
measure: Reduction in BASDAI of 20 mm or 50%
timeFrame: 12-24 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Aabenraa
country: Denmark
facility: Department of Radiology, Aabenraa Hospital
city: Copenhagen
country: Denmark
facility: Department of Radiology, Herlev University Hospital
city: Copenhagen
country: Denmark
facility: Department of Rheumatology, Bispebjerg University Hospital
city: Copenhagen
country: Denmark
facility: Department of Rheumatology, Gentofte University Hospital
city: Copenhagen
country: Denmark
facility: Department of Rheumatology, Glostrup University Hospital
city: Copenhagen
country: Denmark
facility: Department of Rheumatology, Herlev University Hospital
city: Copenhagen
country: Denmark
facility: Department of Rheumatology, Hvidovre University Hospital
city: Graasten
country: Denmark
facility: King Christian X´s Hospital of Rheumatic Diseases
city: Hørsholm
country: Denmark
facility: Department of Rheumatology, Hørsholm Hospital
city: Slagelse
country: Denmark
facility: Department of Rheumatology, Slagelse Hospital
city: Vejle
country: Denmark
facility: Department of Radiology, Vejle Hospital,
city: Vejle
country: Denmark
facility: Department of Rheumatology, Vejle Hospital
city: Århus
country: Denmark
facility: Department of Radiology, Århus University Hospital
Study officials:
affiliation: Department of Rheumatology, Glostrup University Hospital
name: Inge Juul Sørensen, Dr.
role: STUDY_CHAIR
affiliation: Department of Rheumatology, Glostrup University Hospital
name: Susanne Juhl Pedersen, Dr.
role: STUDY_CHAIR
affiliation: Department of Rheumatology, Glostrup University Hospital
name: Mikkel Ostergaard, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.