Symptoms and General Pathology

All Conditions

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Immune System Diseases

Infections

Necrosis

Arthritis

Arthritis, Rheumatoid

Spondylitis

Spondylarthritis

Joint Diseases

Rheumatic Diseases

Collagen Diseases

Connective Tissue Diseases

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Bone Diseases, Infectious

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All Drugs and Chemicals

Anti-Inflammatory Agents

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Antibodies

Antibodies, Monoclonal

Immunoglobulins

Chelating Agents

Certolizumab Pegol

Immunoglobulin Fab Fragments

Sodium Pertechnetate Tc 99m

Tumor Necrosis Factor Inhibitors

Immunosuppressive Agents

Immunologic Factors

In total there will be 20 patients included: 5 patients with active rheumatoid arthritis, 5 patients with active early axial spondyloarthritis, 5 patients with active early peripheral spondyloarthritis and 5 patients with active ankylosing spondylitis.

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).

administration of 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.

Immunoscintigraphy with radiolabeled Cimzia®.

Filip Van den Bosch, MD

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.

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

After performing the immunoscintigraphy there will be evaluation of the correlation between visualised joint inflammation on the one hand seen by clinical examination , on MRI and on ultrasound and on the other hand seen on the immunoscintigraphy.

All patients will be treated with Cimzia®. A specific therapy strategy will be applied: the 10 patients with early spondyloarthropathy (axial and peripheral) that are in a clinical remission on 2 consecutive visites (= week 14, 26, 38 and 50) will stop treatment after a minimum of 26 weeks treatment. If these patients are not in a clinical remission at week 26, then they will be treated further with continuous administration. The 5 patients with active rheumatoid arthritis and 5 patients with already existing longer axial spondyloarthropathy get continuous administration.

A secondary endpoint will be the changes in the tender and swollen joint count (76/78 joint count) at week 26 in comparison with baseline.

This will be done by using the different scoring systems with inclusion of all relevant entheses.

patient global assessment of disease activity, patient pain assessment (peripheral and axial pain), physician global assessment of disease activity, BASDAI and DAS28.

UCB Pharma SA

University Hospital, Ghent

Spots Global Cancer Trial Database for administration of cimzia®