Danish Multicenter Study of Adalimumab in Spondyloarthritis - Full Text View

Sponsor:	Hvidovre University Hospital
Collaborator:	Abbott
Information provided by:	Hvidovre University Hospital
ClinicalTrials.gov Identifier:	NCT00477893

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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

Resource links provided by NLM:

Drug Information available for: Adalimumab

U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

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: Placebo Comparator	Drug: Placebo sc. inj. placebo every other week, week 0, 2, 4, 6, 8, and 10.
Adalimumab: Active Comparator	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:

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

Exclusion Criteria:

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

Contacts and Locations

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

Locations

Denmark
King Christian X´s Hospital of Rheumatic Diseases
Graasten, Denmark
Department of Rheumatology, Bispebjerg University Hospital
Copenhagen, Denmark
Department of Rheumatology, Hvidovre University Hospital
Copenhagen, Denmark
Department of Rheumatology, Hørsholm Hospital
Hørsholm, Denmark
Department of Rheumatology, Herlev University Hospital
Copenhagen, Denmark
Department of Rheumatology, Gentofte University Hospital
Copenhagen, Denmark
Department of Radiology, Vejle Hospital,
Vejle, Denmark
Department of Rheumatology, Glostrup University Hospital
Copenhagen, Denmark
Department of Rheumatology, Slagelse Hospital
Slagelse, Denmark
Department of Radiology, Herlev University Hospital
Copenhagen, Denmark
Department of Radiology, Århus University Hospital
Århus, Denmark
Department of Radiology, Aabenraa Hospital
Aabenraa, Denmark
Department of Rheumatology, Vejle Hospital
Vejle, Denmark

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

More Information

No publications provided

Responsible Party:	Dep. of Rheumatology, Hvidovre Hospital ( Professor Mikkel Østergaard )
Study ID Numbers:	HUM 04-078
Study First Received:	May 23, 2007
Last Updated:	August 24, 2009
ClinicalTrials.gov Identifier:	NCT00477893 History of Changes
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics; Denmark: Danish Medicines Agency

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Spinal Diseases
Musculoskeletal Diseases
Therapeutic Uses
Joint Diseases
Arthritis

Antirheumatic Agents
Adalimumab
Bone Diseases
Spondylarthritis
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010