EUCTR2009-017998-37-BE
Active, not recruiting
Phase 1
Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFa-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Ghent University Hospital
- Enrollment
- 36
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- age between 18 and 70 years old
- •\- diagnosed with rheumatoid arthrosis according to the ACR\-criteria,
- •diagnosed with axial spondyloarthropathy according to the ASAS criteria (of which 5 of them should meet the modified New York criteria),
- •diagnosed with peripheral spondylarthropathy
- •\- no active tuberculosis
- •\- no pregnant women or women who are not using contraceptives when applicable
- •\- patients need to understand the study and give informed consent
- •OR diagnosed with erosive hand OA
- •OR diagnosed with active Crohn's disease
- •Are the trial subjects under 18? no
Exclusion Criteria
- •\- no experimental (non\-) biological therapy in the last 3 months, or within 5 halflives befor baseline visit
- •\- no anti\-TNF therapy
- •\- no rituximab and/or abatacept
- •\- known hypersensitivity vs certolizumab pegol or one of his components
- •\- medical history of serious progressive uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebreal diseases
- •\- serious or life\-threatening infections over the last 6 months, or signs of current or recent infection
- •\- active or latent tuberculosis
- •\- known previous or current viral hepatitis B or C
- •\- known HIV infection
- •\- presence of malignity or history of maligne pathology
Outcomes
Primary Outcomes
Not specified
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