EUCTR2006-000410-20-BE进行中（未招募）不适用
A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis
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 BV
- 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. Are 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.
- •Are 6 to 17 years old, inclusive, at all other sites.
- •2. Have moderately to severely active UC, defined as a baseline Mayo score of 6 to 12, inclusive.
- •3. Had UC diagnosed at least 3 months prior to screening.
- •4. Must have the diagnosis of UC confirmed by the screening biopsy.
- •5. Must have 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):
- •1) Be receiving adequate treatment* with 6-MP or AZA.
- •2) Have failed to respond to an adequate dose of 6-MP or AZA.
- •3) Have had medical complications and/or AEs from 6-MP or AZA that preclude the use of these medications at doses adequate to treat UC.
- •b. Oral Corticosteroids:
- •1) Be receiving with oral corticosteroids.
- •2) Have failed to respond to an adequate dose of corticosteroids or to successfully taper corticosteroids.
- •3) Have had medical complications and/or AEs from corticosteroids that preclude the use of these medications.
- •7. Must be receiving 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:
- •a. 6-MP, AZA, MTX:
- •1) Must have been receiving 1 of the immunomodulatory agents 6-MP, AZA, or MTX for 8 weeks prior to assessment of the baseline Mayo score.
- •2) If 6-MP, AZA, or MTX has been recently discontinued, it must have been stopped at least 4 weeks prior to Mayo screening procedures.
- •b. Corticosteroids:
- •1) If receiving oral or rectal corticosteroids, the dose must have been stable for at least 2 weeks prior to Mayo screening procedures.
- •2) If oral or rectal corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to Mayo screening procedures.
- •c. 5-ASA compounds:
- •1) If receiving oral or rectal 5-ASA compounds, the dose must have been stable for at least 2 weeks prior to Mayo screening procedures.
- •2) If oral or rectal 5-ASA compounds have been recently discontinued, they must have been stopped at least 2 weeks prior to Mayo screening procedures.
- •d. Bulking or stool softening agents: If using bulking or stool softening agents chronically, the dose must have been stable for at least 2 weeks prior to Mayo screening procedures and a stable dose must be maintained until Week 54.
- •9. If receiving enteral nutrition, must have been on a stable regimen for 2 weeks prior to Mayo screening procedures.
- •10. Must have discontinued the use of antibiotics for the treatment of UC at least 3 weeks prior to Mayo screening procedures.
- •11. Must have at least 1 of the following:
- •a. A well-documented history of chicken pox by medical chart review or careful interview of parents or guardian, OR
- •b. An uncertain history of chicken pox with a positive varicella antibody titer, OR
- •c. A history of varicella vaccination with positive varicella antibody titer.
- •12. If at increased risk for colon cancer must either have had a colonoscopy to assess the presence of dysplasia within 1 year prior to the first infusion at Week 0 or a colonoscopy to assess the presence of malignancy at the screening visit
- •13. Have screening laboratory tests that meet the following criteria:
- •a. Hemoglobin = 8.5 g/dL
- •b. White blood cell count = 3.5 x 10E9/L
排除标准
- •1. Have severe extensive colitis as evidenced by:
- •a. Investigator judgment that the subject is likely to require colectomy within 12 weeks of baseline.
- •b. Symptom complex at screening or baseline visits that includes at least 4 of the following:
- •1) diarrhea with = 6 bowel movements/day with macroscopic blood in stool
- •2) focal severe or rebound abdominal tenderness
- •3) persistent fever (= 37.5°C)
- •4) tachycardia (= 90 beats/minute)
- •5) anemia (= 8.5 g/dL)
- •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, including TB, histoplasmosis, or coccidioidomycosis, prior to screening.
- •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 in the 3 months prior to screening.
- •10. Have immune deficiency syndrome.
- •11. Have documented HIV, AIDS-related complex, or AIDS and/or hepatitis B or
- •hepatitis C.
- •12. Have signs or symptoms of any other medical condition that might predispose the
- •subject to significant infection.
- •13. Receiving total parenteral nutrition within the 2 weeks prior to Mayo screening procedures.
- •14. Received parenteral corticosteroids within 2 weeks prior to Mayo screening procedures.
- •15. Require chronic and frequent use of antimotility agents for control of diarrhea
- •16. Have used laxatives, except for preparation for endoscopy or other procedures,
- •within 1 week prior to Mayo screening procedures.
- •17. Were treated with cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil
- •within 8 weeks prior to screening.
- •18. Have used any investigational drug within 4 weeks prior to screening or within
- •5 half-lives of the investigational agent, whichever is longer.
- •19. Have received prior treatment with infliximab or any other TNF antagonist
- •20. Have known history of allergy to murine proteins or any previous treatment with
- •murine products.
- •21. Have ever received natalizumab or other agents that target alpha-4-integrin.
- •22. Have ever received agents that deplete B cells or T cells.
- •23. Presence of a stoma.
- •24. Presence or history of a fistula.
- •25. Require, or required within the 2 months prior to screening, surgery for active
- •gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or
- •pancreatic abscess requiring surgical drainage, or other conditions possibly
- •confounding the evaluation of benefit from infliximab treatment.
- •26. Have severe, fixed symptomatic stenosis of the large or small intestine.
- •27. Presence or history of colonic obstruction within the 6 months prior to baseline,
- •confirmed by objective radiographic or endoscopic evidence of a stricture with
- •resulting obstruction.
- •28. History of extensive colonic resection that would prevent adequate evaluation of the effect of infliximab on clinical disease activity.
- 另有 3 项未显示
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