- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00133315
TNFalfa Blocking Treatment of Spondylarthropathies
April 9, 2007 updated by: Hvidovre University Hospital
TNFalfa Blocking Treatment of Spondylarthropathies - A Danish Multicenter Study of New Methods for Better Monitoring and Prognostifying Patients With Spondylarthropathies
The purpose of the study is to establish a Danish cohort of spondylarthropathy (SpA) patients who are being treated with TNFalfa blockers.
By following the TNFalfa blocking treated patients the researchers want to identify better biomarkers for disease activity and disease progression.
In addition, the researchers want to identify predictors for disease progression.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment
50
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenhagen, Denmark, 2100
- Rigshospitalet
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Copenhagen, Denmark, 2400
- Bispebjerg Hospital
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Gentofte, Denmark, 2900
- Gentofte Hospital
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Glostrup, Denmark, 2600
- Glostrup Hospital
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Graasten, Denmark, 6300
- Graasten Gighospital
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Herlev, Denmark, 2730
- Herlev Hospital
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Horsens, Denmark, 8700
- Horsens Sygehus
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Hvidovre, Denmark, 2650
- Hvidovre University Hospital
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Vejle, Denmark, 7100
- Vejle Sygehus
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age>18 years old
- 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:
- Wish of pregnancy or nursing
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Inge Juul Soerensen, MD, Ph.D, Hvidovre University Hospital, Dept. of Rheumatology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
August 22, 2005
First Submitted That Met QC Criteria
August 22, 2005
First Posted (Estimate)
August 23, 2005
Study Record Updates
Last Update Posted (Estimate)
April 10, 2007
Last Update Submitted That Met QC Criteria
April 9, 2007
Last Verified
April 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Joint Diseases
- Musculoskeletal Diseases
- Arthritis
- Skin Diseases, Papulosquamous
- Spinal Diseases
- Bone Diseases
- Spondylarthritis
- Psoriasis
- Bone Diseases, Infectious
- Ankylosis
- Arthritis, Psoriatic
- Spondylitis
- Spondylitis, Ankylosing
- Spondylarthropathies
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gastrointestinal Agents
- Dermatologic Agents
- Etanercept
- Adalimumab
- Infliximab
Other Study ID Numbers
- 232-001
- KF 02-050/04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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