NL-OMON39620已完成不适用
A PHASE 0 SINGLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS/-DYNAMICS AND SPECIFIC TARGETING PROPERTIES OF 124-I-F8IL10 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS AND INFLAMMATORY BOWEL DISEASE - phase 0 PET-CT study with 124-I-F8IL10 in RA and IBD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •For patients with Rheumatoid Arthritis:;1. Diagnosis of RA according to ACR criteria;2. Active RA (Disease Activity Score 28 * 3.2);3. 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.;For patients with Inflammatory Bowel Disease:;1. diagnosis of IBD to clicinico -pathologic criteria;2. clinically active IBD:
- •a. Crohn*s disease: active Crohn*s disease, with a CDAI (Crohn*s Disease Activity index) > 220 [Best et al. Gastroenterology 1976] with CDEIS (Crohn*s disease endoscopic index of severety) > 15 [Mary et al. Gut, 1989] assessed via colonoscopy or MRI enteroclysis within 4 weeks of dosing.;b. Ulcerative Colitis: active ulcerative colitis, Mayo score > assessed via colposcopy within 4 weeks of dosing.;3. Treatment with aminosalacylates, immunomodulators, biological and corticosteroids up to 20 mg. dialy is permitted, provided that there is a stable dose for at least 2 weeks.;For ALL patients;1. Patients aged *18 years;2. All acute toxic effects of any prior therapy returned to classification mild according to MedDRA;3. Sufficient hematologic, liver and renal function: total white cell count as well as ANC should be normal prior to start 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 < 3 x upper limit of reference range (ULN), and total bilirubin < 2.0 mg/gL;c. Creatinine < 1.5 ULN or 24 h creatinine clearance > 50 mL/min;4. Negative serum pregnancy test for females of childbearing age prior to starting treatment;5. 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.;6. 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;7. Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study
排除标准
- •Patients must not be enrolled in the study if, at the time of enrollment, they have any of the following. ;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 immonodeficiency;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. ing:;17. For patient undergoing MRI:
- •a. electronically, magnetically and mechanically activated implants.
- •b. cardiac pacemakers
- •c. ferromagnetic haemostatic clips in the central nervous system (CNS) or in the body.
- •d. cochlear implants or stapedial implants.
- •e. insulin pumps and nerve stimulators.
- •f. prosthetic heart valves
- •g. ferromagnetic or electrically operated active devices like automatic cardioverter defebrillators.
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