Back to resultsTNFalfa Blocking Treatment of Spondylarthropathies
Primary Purpose
Spondylarthropathies, Ankylosing Spondylitis, Psoriatic Arthritis
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Infliximab
Etanercept
Adalimumab
Sponsored by
About this trial
This is an interventional treatment trial for Spondylarthropathies
Eligibility Criteria
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
Sites / Locations
- Rigshospitalet
- Bispebjerg Hospital
- Gentofte Hospital
- Glostrup Hospital
- Graasten Gighospital
- Herlev Hospital
- Horsens Sygehus
- Hvidovre University Hospital
- Vejle Sygehus
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00133315
First Posted
August 22, 2005
Last Updated
April 9, 2007
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00133315
Brief Title
TNFalfa Blocking Treatment of Spondylarthropathies
Official Title
TNFalfa Blocking Treatment of Spondylarthropathies - A Danish Multicenter Study of New Methods for Better Monitoring and Prognostifying Patients With Spondylarthropathies
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylarthropathies, Ankylosing Spondylitis, Psoriatic Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Infliximab
Intervention Type
Drug
Intervention Name(s)
Etanercept
Intervention Type
Drug
Intervention Name(s)
Adalimumab
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inge Juul Soerensen, MD, Ph.D
Organizational Affiliation
Hvidovre University Hospital, Dept. of Rheumatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Gentofte Hospital
City
Gentofte
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Glostrup Hospital
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Graasten Gighospital
City
Graasten
ZIP/Postal Code
6300
Country
Denmark
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Horsens Sygehus
City
Horsens
ZIP/Postal Code
8700
Country
Denmark
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Vejle Sygehus
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
22127697
Citation
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.
Results Reference
derived
PubMed Identifier
21551511
Citation
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.
Results Reference
derived
PubMed Identifier
19740906
Citation
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.
Results Reference
derived
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TNFalfa Blocking Treatment of Spondylarthropathies
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