Danish Multicenter Study of Adalimumab in Spondyloarthritis

Can New Imaging- and Bio-markers Improve the Assessment of Disease Activity and Progression and Predict Therapeutic Outcome in Spondyloarthritis Patients Receiving Adalimumab

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00477893

Acronym

DANISH

Enrollment

Registered

2007-05-24

Start date

2006-02-28

Completion date

2013-01-31

Last updated

2012-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spondyloarthritis

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

Interventions

DRUGAdalimumab

sc. injection Humira 40 mg every other week, from week 0 or 12 to the end of study

DRUGPlacebo

sc. inj. placebo every other week, week 0, 2, 4, 6, 8, and 10.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Reduction in BASDAI of 20 mm or 50%	12-24 weeks of treatment

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026