Rheumatoid Arthritis
Conditions
Interventions
A single dose of 0.4 mg F8IL10 labeled with up to 2 mCi (74 MBq) Iodine-124, followed by three PET-CT scans and blood sampling.
Sponsors
VU University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged ≥18 years; 2. Diagnosis of RA according to ACR criteria; 3. Active RA (Disease Activity Score 28 >3.2); 4. Treatment with disease modifying anti-rheumatic drugs (DMARDS), biologicals and in addition, corticosteroids up to 10 mg daily and non-steroidal anti-inflammatory drugs (NSAIDs) is permitted, provided that there is a stable dose for at least 2 weeks; 5. All acute toxic effects of any prior therapy returned to classification mild according to MedDRA; 6. Sufficient hematologic, liver and renal function: total white cell count as well as ANC should be normal prior to start of the treatment, as well as liver function tests: A. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, haemoglobin (Hb) ≥ 9.5 g/dL; B. Alkaline phosphatase (AP), alanine aminotransferase (ALT) and/or aspartate aminotransferase 50 mL/min. 7. Negative serum pregnancy test for females of childbearing age prior to starting treatment; 8. Male patients, who are potentially fertile, must agree to use adequate contraceptive methods at the beginning of the screening visit and continue until 3 months following the last treatment with the study drug; 9. Evidence of a personally signed and dated Ethics Committee-approved Informed Consent form indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the study; 10. Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
Exclusion criteria
Exclusion criteria: 1. Presence of active infections (e.g. requiring antibiotic therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study; 2. Chronic active hepatitis (hepatitis B/C) or active autoimmune diseases other than RA; 3. Known primary or secondary immunodeficiency; 4. HIV positive patient; 5. Evidence of active malignant disease, malignancies diagnosed within the previous 5 years; 6. History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris; 7. Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria); 8. Irreversible cardiac arrhythmias requiring permanent medication; 9. Uncontrolled hypertension; 10. Ischemic peripheral vascular disease (Grade IIb-IV); 11. Severe diabetic retinopathy; 12. Recovery from major trauma including surgery within 4 weeks of administration of study treatment; 13. Known history of allergy to IL-10 or other intravenously administered human proteins/peptides/antibodies; 14. Pregnancy or breast feeding; 15. Any conditions that in the opinion of the investigator could hamper compliance with the study protocol; 16. Previous exposure to radioactivity with a yearly cumulative dose of ≥ 5 mSv.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the targeting performance (including pharmacokinetics/-dynamics) of the human radiolabeled monoclonal-antibody cytokine fusion protein 124I-F8IL10 in 5 patients with rheumatoid arthritis, in a single dose study. | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate dosimetric parameters of arthritic joints and internal organs. | — |
Contacts
Public ContactJ. Laken, van der
Department of Rheumatology VU University Medical Center PO Box 7057
Outcome results
None listed