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Danish Multicenter Study of Adalimumab in Spondyloarthritis (DANISH)

Primary Purpose

Spondyloarthritis

Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Adalimumab
Placebo
Sponsored by
Glostrup University Hospital, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spondyloarthritis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Adalimumab

Arm Description

Outcomes

Primary Outcome Measures

Reduction in BASDAI of 20 mm or 50%

Secondary Outcome Measures

Full Information

First Posted
May 23, 2007
Last Updated
March 27, 2012
Sponsor
Glostrup University Hospital, Copenhagen
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00477893
Brief Title
Danish Multicenter Study of Adalimumab in Spondyloarthritis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Glostrup University Hospital, Copenhagen
Collaborators
Abbott

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondyloarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Adalimumab
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Intervention Description
sc. injection Humira 40 mg every other week, from week 0 or 12 to the end of study
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
sc. inj. placebo every other week, week 0, 2, 4, 6, 8, and 10.
Primary Outcome Measure Information:
Title
Reduction in BASDAI of 20 mm or 50%
Time Frame
12-24 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inge Juul Sørensen, Dr.
Organizational Affiliation
Department of Rheumatology, Glostrup University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Susanne Juhl Pedersen, Dr.
Organizational Affiliation
Department of Rheumatology, Glostrup University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mikkel Ostergaard, Professor
Organizational Affiliation
Department of Rheumatology, Glostrup University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiology, Aabenraa Hospital
City
Aabenraa
Country
Denmark
Facility Name
Department of Radiology, Herlev University Hospital
City
Copenhagen
Country
Denmark
Facility Name
Department of Rheumatology, Bispebjerg University Hospital
City
Copenhagen
Country
Denmark
Facility Name
Department of Rheumatology, Gentofte University Hospital
City
Copenhagen
Country
Denmark
Facility Name
Department of Rheumatology, Glostrup University Hospital
City
Copenhagen
Country
Denmark
Facility Name
Department of Rheumatology, Herlev University Hospital
City
Copenhagen
Country
Denmark
Facility Name
Department of Rheumatology, Hvidovre University Hospital
City
Copenhagen
Country
Denmark
Facility Name
King Christian X´s Hospital of Rheumatic Diseases
City
Graasten
Country
Denmark
Facility Name
Department of Rheumatology, Hørsholm Hospital
City
Hørsholm
Country
Denmark
Facility Name
Department of Rheumatology, Slagelse Hospital
City
Slagelse
Country
Denmark
Facility Name
Department of Radiology, Vejle Hospital,
City
Vejle
Country
Denmark
Facility Name
Department of Rheumatology, Vejle Hospital
City
Vejle
Country
Denmark
Facility Name
Department of Radiology, Århus University Hospital
City
Århus
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
26414004
Citation
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.
Results Reference
derived

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Danish Multicenter Study of Adalimumab in Spondyloarthritis

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