Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFa-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy.

Phase 1

• Conditions: Patients with an active spondyloarthropathy and with an active rheumatoid arthritis; who were diagnosed according to the classic ACR-criteria (American College of Rheumatology) for rheumatoid arthritis and according the ASAS-criteria (Assessment of SpondyloArthritis international Society) for spondylarthropathy. Patients with an active rheumatoid arthritis or with an active axial and peripheral spondyloarthropathy. Patients with erosive hand arthrosis. Patients with an active Crohn's disease.; MedDRA version: 19.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 19.0 Level: HLT Classification code 10052775 Term: Spondyloarthropathies System Organ Class: 100000004859; MedDRA version: 19.0 Level: HLT Classification code 10039078 Term: Rheumatoid arthropathies System Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2009-017998-37-BE
• Lead Sponsor: Ghent University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-11
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

- age between 18 and 70 years old
- diagnosed with rheumatoid arthrosis according to the ACR-criteria,
OR
diagnosed with axial spondyloarthropathy according to the ASAS criteria (of which 5 of them should meet the modified New York criteria),
OR
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
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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
- History or signs of lyph-proliferative condition
- mild to serious cardiac failure

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified