MedTrace Logo

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

NCT01590966 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2019-08-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

administration of Cimzia®

Patients will be treated with prefilled syringes containing each 200 mg/ml Cimzia® every 2 weeks which will be administered subcutaneously (The first 3 injections, a dosage of 400mg Cimzia® subcutaneously will be administered).

DRUG

Immunoscintigraphy with radiolabeled Cimzia®.

All 20 patients will undergo an immunoscintigraphy with radiolabeled Cimzia®. Certolizumab pegol (Cimzia®) is an engineered humanized monoclonal antibody Fab' fragment with specificity for human TNF-α, manufactured in E. coli. The antibody fragment is subsequently purified and conjugated with high molecular weight polyethylene glycol (PEG) (40kDa). Lyophilized Cimzia® will be conjugated with S-HYNIC (a bifunctional chelator). The conjugate will be radiolabeled with Tc-99m by adding 0.1 mg Tricine, 0.01 mg SnSO4 and 750 MBq Tc-99m pertechnetate. A dose of 750 MBq Tc-99m Cimzia® will be injected intravenously.

Sponsors & Collaborators

  • UCB Pharma SA

    collaborator INDUSTRY

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Filip Van den Bosch, MD · University Hospital, Ghent

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-18
Primary Completion
2019-03-26
Completion
2019-08-20

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01590966 on ClinicalTrials.gov