Danish Multicenter Study of Adalimumab in Spondyloarthritis (DANISH)

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

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.

Study Overview

• Status: Unknown
• Conditions: Spondyloarthritis
• Intervention / Treatment: Drug: Placebo; Drug: Adalimumab

Detailed Description

See brief summary

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Aabenraa, Denmark
    • Department of Radiology, Aabenraa Hospital
  • Copenhagen, 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
  • Graasten, Denmark
    • King Christian X´s Hospital of Rheumatic Diseases
  • Hørsholm, Denmark
    • Department of Rheumatology, Hørsholm Hospital
  • Slagelse, Denmark
    • Department of Rheumatology, Slagelse Hospital
  • Vejle, Denmark
    • Department of Radiology, Vejle Hospital,
  • Vejle, Denmark
    • Department of Rheumatology, Vejle Hospital
  • Århus, Denmark
    • Department of Radiology, Århus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; sc. inj. placebo every other week, week 0, 2, 4, 6, 8, and 10.
Active Comparator: Adalimumab	Drug: Adalimumab; sc. injection Humira 40 mg every other week, from week 0 or 12 to the end of study

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Glostrup University Hospital, Copenhagen
• Collaborators: Abbott
• Investigators: Study Chair: Inge Juul Sørensen, Dr., Department of Rheumatology, Glostrup University Hospital; Study Chair: Susanne Juhl Pedersen, Dr., Department of Rheumatology, Glostrup University Hospital; Principal Investigator: Mikkel Ostergaard, Professor, Department of Rheumatology, Glostrup University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): January 1, 2009
• Study Completion (Anticipated): January 1, 2013

Study Registration Dates

• First Submitted: May 23, 2007
• First Submitted That Met QC Criteria: May 23, 2007
• First Posted (Estimate): May 24, 2007

Study Record Updates

• Last Update Posted (Estimate): March 28, 2012
• Last Update Submitted That Met QC Criteria: March 27, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Spondylitis; Spondylarthritis; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: HUM 04-078