Clinical trial NCT00133315: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spondylarthropathies
Ankylosing Spondylitis
Psoriatic Arthritis
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2005-08-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Gentofte
country: Denmark
facility: Gentofte Hospital
city: Glostrup
country: Denmark
facility: Glostrup Hospital
city: Graasten
country: Denmark
facility: Graasten Gighospital
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Horsens
country: Denmark
facility: Horsens Sygehus
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
city: Vejle
country: Denmark
facility: Vejle Sygehus
Study officials:
affiliation: Hvidovre University Hospital, Dept. of Rheumatology
name: Inge Juul Soerensen, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.