Danish Multicenter Study of Adalimumab in Spondyloarthritis

NCT ID: NCT00477893

Last Updated: 2012-03-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2013-01-31

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

Conditions

Spondyloarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Adalimumab

Group Type: ACTIVE_COMPARATOR

Adalimumab

Intervention Type: DRUG

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

Interventions

Adalimumab

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

MOstergaard

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Inge Juul Sørensen, Dr.

Role: STUDY_CHAIR

Department of Rheumatology, Glostrup University Hospital

Susanne Juhl Pedersen, Dr.

Role: STUDY_CHAIR

Department of Rheumatology, Glostrup University Hospital

Mikkel Ostergaard, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Rheumatology, Glostrup University Hospital

Locations

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

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 26414004 (View on PubMed)

Other Identifiers

HUM 04-078

Identifier Type: -

Identifier Source: org_study_id