Danish Multicenter Study of Adalimumab in Spondyloarthritis

Spondyloarthritis Clinical Trial

— DANISH  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00477893
• Other study ID #: HUM 04-078
• Status: Active, not recruiting
• Phase: Phase 4
• First received: May 23, 2007
• Last updated: March 27, 2012
• Start date: February 2006
• Est. completion date: January 2013

Study information

• Verified date: March 2012
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Description:

See brief summary

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: January 2013
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 TNFa 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

Study Design

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

Related Conditions & MeSH terms

• Spondylarthritis
• Spondyloarthritis

Intervention

Drug:
• Adalimumab
sc. injection Humira 40 mg every other week, from week 0 or 12 to the end of study
• Placebo
sc. inj. placebo every other week, week 0, 2, 4, 6, 8, and 10.

Locations

Country	Name	City	State
Denmark	Department of Radiology, Aabenraa Hospital	Aabenraa
Denmark	Department of Radiology, Århus University Hospital	Århus
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

Sponsors (2)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen	Abbott

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in BASDAI of 20 mm or 50%		12-24 weeks of treatment	No