EUCTR2006-000410-20-IT进行中（未招募）不适用
A Phase 3, Randomized, Open-label, Parallel-group, MulticenterTrial to Evaluate the Safety and Efficacy of Infliximab(REMICADE) in Pediatric Subjects with Moderately to SeverelyActive Ulcerative Colitis - Protocol C0168T72
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- CENTOCOR
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Aged 6 to 16 years old, inclusive, if enrolled at a site that cannot treat and/or follow subjects once they become 18 years of age or aged 6 to 17 years old, inclusive, at all other sites.
- •2. Affected by moderately to severely active UC, defined as a baseline Mayo score of 6 to 12, inclusive.
- •3. Affected by UC diagnosed at least 3 months prior to screening..
- •4. Diagnosis of UC confirmed by the screening biopsy.
- •5. Affected by moderately to severely active UC confirmed during the screening sigmoidoscopy by a ≥ 2 endoscopy subscore of the Mayo score.
- •6. Must meet at least 1 of the following criteria:
- •a. Immunomodulators (6-MP or AZA): Be receiving adequate treatment with 6-MP or AZA, or have failed (within the last 5 years) to respond to an adequate dose of 6-MP or AZA, or have had medical complications and/or AEs from 6-MP or AZA (within the last 5 years) that, in the judgment of the subject?s physician, preclude the use of these medications at doses adequate to treat UC.
- •b. Oral Corticosteroids: Be receiving adequate treatment with oral corticosteroids or have failed (within the past 2 years) to respond to an adequate dose of corticosteroids or to successfully taper corticosteroids (ie, had a flare of disease on tapering to < 10 mg of prednisone on 2 separate occasions), or have had medical complications and/or AEs from corticosteroids (within the past 2 years) that, in the judgment of the subject?s physician, preclude the use of these medications.
- •7. Must be receiving (at no specific dose) 6-MP, AZA, or MTX because of the potential of these drugs to prevent the formation of antibodies to infliximab.
- •8. Must meet concomitant medication stability criteria, as appropriate for a. 6-MP, AZA, MTX, b. Corticosteroids, c. 5-ASA compounds, d. Bulking or stool softening agents.
- •9. Must have discontinued the use of antibiotics for the treatment of UC at least 3 weeks prior to Mayo screening procedures.
- •10. Must have a well-documented history of chicken pox or an uncertain history of chicken pox with a positive varicella antibody titer, or an history of varicella vaccination with positive varicella antibody titer.
- •11. If at increased risk for colon cancer must either have had a colonoscopy to assess the presence of dysplasia.
- •12. Have screening laboratory tests that meet the following criteria: Hemoglobin ≥ 8.5 g/dL; White blood cell count ≥ 3.5 x 109/L; Neutrophils ≥ 1.5 x 109/L; Platelets ≥ 100 x 109/L
- •13. Male subjects who are sexually active and female subjects of childbearing potential who are sexually active must agree to use adequate birth control measures.
- •14. Signed written consent from the parent/legal guardian and assent from the child (age at which assent is given may vary by IRB/EC) must be obtained prior to any protocol-specified procedures.
- •15 Are considered eligible according to the following TB screening criteria: have no history of latent or active TB prior to screening.; have no signs or symptoms suggestive of active TB upon medical history and/or physical examination, have had no recent close contact with a person with active TB, within 1 month prior to the first administration of study agent, have a negative tuberculin skin test, have a chest radiograph (posterior-anterior view), taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current active TB or old inactive TB.
- •Are the trial subjects under 18
排除标准
- •Subjects meeting any of the following criteria may not be enrolled:
- •1. Have severe extensive colitis as evidenced.
- •2. Have UC limited to the rectum only or to < 20 cm of the colon.
- •3. Have a history of latent or active granulomatous infection.
- •4. Have had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening.
- •5. Have had a chest radiograph within 3 months prior to the first administration of study agent that shows an abnormality suggestive of a malignancy or current active infection, including TB.
- •6. Have had a nontuberculous mycobacterial infection or opportunistic infection within 6 months prior to screening.
- •7. Have had a live viral or bacterial vaccination within 3 months prior to screening.
- •8. Have a positive stool culture for enteric pathogens.
- •9. Have or have had serious infection (such as hepatitis, pneumonia, or pyelonephritis) in the 3 months prior to screening. Less serious infections (such as acute upper respiratory tract infections [colds]) need not be considered exclusionary criteria at the discretion of the investigator.
- •10. Have immune deficiency syndrome.
- •11. Have documented HIV, AIDS-related complex, or AIDS and/or hepatitis B or hepatitis C.
- •12. Receiving total parenteral nutrition (TPN) within the 2 weeks prior to Mayo screening procedures.
- •13. Received parenteral corticosteroids within 2 weeks prior to Mayo screening procedures.
- •14. Require chronic and frequent use of antimotility agents for control of diarrhea .
- •15. Have used laxatives, except for preparation for endoscopy or other procedures, within 1 week prior to Mayo screening procedures.
- •16 Were treated with cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil (MMF) within 8 weeks prior to screening.
- •17. Have used any investigational drug within 4 weeks prior to screening or within 5 half-lives of the investigational agent, whichever is longer.
- •18. Have received prior treatment with infliximab or any other TNF antagonist.
- •19. Have known history of allergy to murine proteins or any previous treatment with murine products.
- •20. Have ever received natalizumab or other agents that target alpha-4-integrin.
- •21. Have ever received agents that deplete B cells (eg, rituximab) or T cells (eg, alemtuzamab).
- •22. Presence of a stoma.
- •23. Presence or history of a fistula.
- •24. Require, or required within the 2 months prior to screening, surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess or other conditions possibly confounding the evaluation of benefit from infliximab treatment.
- •25. Have severe, fixed symptomatic stenosis of the large or small intestine.
- •26. Presence or history of colonic obstruction within the 6 months prior to baseline.
- •27. History of extensive colonic resection.
- •28. History of colonic mucosal dysplasia.
- •29. Presence on screening endoscopy of adenomatous colonic polyps, if not removed prior to study entry, or history of adenomatous colonic polyps that were not removed.
- •30. Presence or history of any malignancy within 5 years of screening.
- •31. History of lymphoproliferative disease.
- •32. Concomitant diagnosis or history of CHF, including medically controlled asymptomatic CHF.
- •33. Have signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, psychiatric, or cerebral diseases.
- •34. History of systemic lupus erythematosus.
- •35. Received an organ transplant.
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