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

PHASE3CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

October 18, 2012

Primary Completion Date

March 26, 2019

Study Completion Date

August 20, 2019

Conditions
Axial and Peripheral SpondyloarthritisRheumatoid Arthritis
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.

Trial Locations (1)

9000

Ghent University Hospital, Ghent

All Listed Sponsors
collaborator

UCB Pharma SA

INDUSTRY

lead

University Hospital, Ghent

OTHER

NCT01590966 - 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 | Biotech Hunter | Biotech Hunter