Scintigraphic Detection of the Biodistribution of Tumor Necrosis Factor With a Radiolabeled Anti-… (NCT01590966) | Clinical Trial Compass
CompletedPhase 3
Scintigraphic Detection of the Biodistribution of Tumor Necrosis Factor With a Radiolabeled Anti-TNFα in Patients With Active Rheumatoid Arthritis and Active Axial and Peripheral Spondyloarthritis
Belgium41 participantsStarted 2012-10-18
Plain-language summary
In this open-label monocentric explorative pilot trial the objective is to show the biodistribution of TNFα by administration of radiolabeled anti-TNFα in patients with active rheumatoid arthritis and spondylarthropathy. The anti-TNFα used in this trial is certolizumab pegol (Cimzia®), a pegylated Fab'-fragment of a monoclonal antibody with high specificity for TNFα. Certolizumab pegol will be radiolabeled with 99mTechnetium. The aim of this study is to show the TNFα triggered inflammation process in the inflamed joints, especially in patients who have very early joint damage where currently other imaging methods such as X-rays are not sensitive enough for detection.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
INCLUSION CRITERIA FOR RHEUMATOID ARTHRITIS PATIENTS (5 PATIENTS)
* Age between 18 and 70 years-old with documented diagnosis (clinical evaluation, x-ray hands and feet minimum 2 months before inclusion) of rheumatoid arthritis minimum 3 months and maximum 15 years according to ACR criteria 1987. At least 8 tender and 8 swollen joints with inadequate response to at least 2 disease-modifying antirheumatic drugs (DMARDs) of which one is Methotrexate (MTX). Methotrexate must have been administered at least 3 months before baseline and doses and route must be stable for at least 2 months before baseline. Minimum dosage of MTX is 10 mg weekly and maximum dosage is 25 mg weekly. HAQ (Health assessment Score) score at least 25 at baseline and DAS 28(Disease Activity Score) \> 3.7 at baseline.
* All patients are biological naïve patients.
* Negative for Tuberculosis (TB) (also in history) and negative screening for TB (Mantoux test / x-ray thorax)
* Female patients must be post-menopausal for at least 1 year or must underwent surgery so that they cannot become pregnant. Women of child bearing potential must use adequate contraception throughout the study and 12 weeks after the last dose of certolizumab pegol.
* Patient need to understand the study and sign an informed consent form approved by the ethics committee before participation in this study.
INCLUSION CRITERIA FOR PATIENTS WITH AXIAL SPONDYLARTHROPATY (15 PATIENTS)
* Age between 18 and 70-years old with presence of a docume…
What they're measuring
1
Biodistribution of Cimzia® after administration of radiolabeled Cimzia®.
Timeframe: at baseline
2
Percentage of remission in patients, treated with Cimzia® after 14 weeks.
Timeframe: After 14 weeks of administration.
3
Percentage of remission in patients, treated with Cimzia® after 26 weeks.
Timeframe: After 26 weeks of administration.
4
Percentage of remission in patients, treated with Cimzia® after 38 weeks.
Timeframe: After 38 weeks of administration.
5
Percentage of remission in patients, treated with Cimzia® after 50 weeks.
Timeframe: After 50 weeks of administration.
6
Duration of remission in patients, treated with Cimzia® after 14 weeks.
Timeframe: After 14 weeks of administration.
7
Duration of remission in patients, treated with Cimzia® after 26 weeks.