Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2004-09-30
2007-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Infliximab
Etanercept
Adalimumab
Eligibility Criteria
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Inclusion Criteria
* Spondylarthropathies according to the European Spondylarthropathy Study Group (ESSG) criteria
* Sacroiliitis by X-ray or magnetic resonance imaging (MRI)
* Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)\>3
* No signs of tuberculosis (TB)
* Sufficient contraception
Exclusion Criteria
* Previous treatment with TNFalfa blocker
* Disease-modifying anti-rheumatic drugs (DMARDs) other than methotrexate (MTX) later than 4 weeks before inclusion
* Steroid treatment later than 4 weeks before inclusion
* Immunosuppressing agents later than 4 weeks before inclusion
* Severe infections within 3 months
* HIV-infection
* Active hepatitis B and C
* Active or latent TB
* Severe chronic diseases
* Heart insufficiency (New York Heart Association \[NYHA\] 3 and 4)
* Malignancy
* Systemic lupus erythematosus (SLE) or SLE-like disease
* Abuse of narcotics or alcohol
* Major psychiatric disorders
18 Years
ALL
No
Sponsors
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Hvidovre University Hospital
OTHER
Principal Investigators
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Inge Juul Soerensen, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Hvidovre University Hospital, Dept. of Rheumatology
Locations
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Rigshospitalet
Copenhagen, , Denmark
Bispebjerg Hospital
Copenhagen, , Denmark
Gentofte Hospital
Gentofte Municipality, , Denmark
Glostrup Hospital
Glostrup Municipality, , Denmark
Graasten Gighospital
Gråsten, , Denmark
Herlev Hospital
Herlev, , Denmark
Horsens Sygehus
Horsens, , Denmark
Hvidovre University Hospital
Hvidovre, , Denmark
Vejle Sygehus
Vejle, , Denmark
Countries
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References
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Pedersen SJ, Sorensen IJ, Lambert RG, Hermann KG, Garnero P, Johansen JS, Madsen OR, Hansen A, Hansen MS, Thamsborg G, Andersen LS, Majgaard O, Loft AG, Erlendsson J, Asmussen KH, Jurik AG, Moller J, Hasselquist M, Mikkelsen D, Ostergaard M. Radiographic progression is associated with resolution of systemic inflammation in patients with axial spondylarthritis treated with tumor necrosis factor alpha inhibitors: a study of radiographic progression, inflammation on magnetic resonance imaging, and circulating biomarkers of inflammation, angiogenesis, and cartilage and bone turnover. Arthritis Rheum. 2011 Dec;63(12):3789-800. doi: 10.1002/art.30627.
Pedersen SJ, Sorensen IJ, Garnero P, Johansen JS, Madsen OR, Tvede N, Hansen MS, Thamsborg G, Andersen LS, Majgaard O, Loft AG, Erlendsson J, Asmussen K, Jurik AG, Moller J, Hasselquist M, Mikkelsen D, Skjodt T, Lambert R, Hansen A, Ostergaard M. ASDAS, BASDAI and different treatment responses and their relation to biomarkers of inflammation, cartilage and bone turnover in patients with axial spondyloarthritis treated with TNFalpha inhibitors. Ann Rheum Dis. 2011 Aug;70(8):1375-81. doi: 10.1136/ard.2010.138883. Epub 2011 May 8.
Pedersen SJ, Sorensen IJ, Hermann KG, Madsen OR, Tvede N, Hansen MS, Thamsborg G, Andersen LS, Majgaard O, Loft AG, Erlendsson J, Asmussen K, Johansen JS, Jurik AG, Moller J, Hasselquist M, Mikkelsen D, Skjodt T, Hansen A, Ostergaard M. Responsiveness of the Ankylosing Spondylitis Disease Activity Score (ASDAS) and clinical and MRI measures of disease activity in a 1-year follow-up study of patients with axial spondyloarthritis treated with tumour necrosis factor alpha inhibitors. Ann Rheum Dis. 2010 Jun;69(6):1065-71. doi: 10.1136/ard.2009.111187. Epub 2009 Sep 9.
Other Identifiers
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KF 02-050/04
Identifier Type: -
Identifier Source: secondary_id
232-001
Identifier Type: -
Identifier Source: org_study_id