Status:
TERMINATED
Discontinuation of TNF-alpha Inhibitors in Patients With Spondyloarthritis
Lead Sponsor:
Glostrup University Hospital, Copenhagen
Conditions:
SPONDYLOARTHRITIS
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Spondylarthropathy (SpA) comprises a group of rheumatic diseases mainly affecting the spine and sacroiliac joints. In most of the patients disease activity alternates, and some patients have symptom f...
Eligibility Criteria
Inclusion
- At least 12 months of treatment with infliximab, etanercept and adalimumab.
- Diagnosis of spondylarthritis according to the European Spondyloarthritis Study Group (ESSG) criteria or modified New York Criteria
- No clinical active disease, defined as a BASDAI score \< 4.
- Among other issues: Age \>18 years; written informed consent, adequate birth control; no contraindications for anti-TNF-alpha-therapy
Exclusion
- 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-TNF-alpha-therapy
- Contraindications to MRI
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00726804
Start Date
March 1 2008
End Date
May 1 2012
Last Update
August 19 2015
Active Locations (6)
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1
Glostrup Hospital
Copenhagen, Denmark, 2600
2
Glostrup Hospital
Copenhagen, Denmark, 2650
3
Gentofte Hospital
Copenhagen, Denmark, 2730
4
Gentofte Hospital
Copenhagen, Denmark, 2900