EUCTR2017-004496-31-ES进行中（未招募）1 期
A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFaMonoclonal Antibody, Administered Subcutaneously in PediatricParticipants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 125
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. Must be 2 to 17 years of age (at the time of the first administration of
- •study intervention at Week 0) of either gender with a body weight =10
- •kg and >70 cm height.
- •2. Must have had UC diagnosed for at least 1 month prior to screening.
- •3. Must have the diagnosis of UC confirmed by a prior endoscopic biopsy
- •that is consistent with a diagnosis of UC (eg, crypt distortion, crypt
- •abscess, goblet cell depletion, and continuous distribution).
- •4. Must have moderately to severely active UC (as defined by baseline
- •Mayo score of 6 through 12 [endoscopy {sigmoidoscopy or colonoscopy}
- •subscore assigned by local endoscopist], inclusive).
- •5. Must have a Mayo endoscopy (sigmoidoscopy or colonoscopy)
- •subscore =2 (subscore assigned by local endoscopist) at baselineendoscopy (indicative of moderately to severely active UC). Baseline
- •endoscopy (sigmoidoscopy or colonoscopy) must be performed with
- •study software and occur no more than 2 weeks before first study
- •intervention administration.
- •6. Prior or current medication for UC must include at least 1 of the following (Appendix 2
- •[Section 10.2]):
- •a. Current treatment with at least 1 of the following therapies: oral or intravenous
- •corticosteroids, or the immunomodulators 6-MP, MTX, or AZA.
- •b. Have a history of failure to respond to or tolerate, or have a medical
- •contraindication to, at least 1 of the following therapies: oral or intravenous
- •corticosteroids or the immunomodulators 6-MP, MTX, or AZA.
- •c. Currently have or have had a history of corticosteroid dependency (ie, an
- •inability to successfully taper corticosteroids without a return of the symptoms
- •d. Have required more than 3 courses of oral or intravenous corticosteroids in the
- •7. Must meet concomitant medication stability criteria prior to the first
- •administration of study intervention.
- •8. If receiving parenteral or enteral nutrition, must have been on a
- •stable regimen for at least 2 weeks prior to the first administration of
- •study intervention at Week 0.
- •9. Must have discontinued the use of antibiotics for the treatment of UC
- •(eg, ciprofloxacin, metronidazole, or rifaximin) for at least 1 week prior
- •to screening.
- •10. Must have discontinued the use of 6-thioguanine (6-TG) for at least 4
- •weeks prior to screening.
- •11. 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 administration of study intervention at Week 0 or a colonoscopy
- •to assess the presence of malignancy as the baseline endoscopy.
- •Baseline endoscopy (sigmoidoscopy or colonoscopy) must be performed
- •with study software and occur no more than 2 weeks before first study
- •intervention administration.
- •12. Before randomization, a girl must be either:
- •a. Not of childbearing potential defined as:
- •1) Premenarchal
- •2) Permanently sterile
- •b. Of childbearing potential and
- •1) Practicing a highly effective method of contraception (failure rate of
- •<1% per year when used consistently and correctly) during the study
- •and for 6 months after receiving the last dose of study intervention. Both
- 另有 7 项未显示
排除标准
- •1. Have severe, extensive colitis as evidenced by:
- •a. Investigator judgment that the participant is likely to require a
- •colectomy within 12 weeks of Week 0.
- •b. Symptom complex at screening or Week 0 visit that includes at least 4
- •of the following:
- •1) Diarrhea with =6 bowel movements/day with macroscopic blood in
- •2) Focal severe or rebound abdominal tenderness
- •3) Persistent fever (=37.5°C) for more than 5 days
- •4) Persistent tachycardia for more than 5 days
- •5) Anemia (hemoglobin < 8.5 g/dL)
- •2. Participants with very severe active UC disease who are currently
- •hospitalized for UC disease exacerbation when initiating study screening
- •and who have a Mayo score of 12 should be excluded from the study.
- •3. History of liver or renal insufficiency; significant cardiac, vascular,
- •pulmonary, gastrointestinal, endocrine, neurologic, hematologic,
- •rheumatologic, psychiatric (including suicidality), or metabolic
- •disturbances.
- •4. History of malignancy or macrophage activation syndrome (MAS) or
- •hemophagocytic lymphohistiocytosis (HLH).
- •5. A serious allergic reaction to latex.
- •6. Contraindications to the use of golimumab or infliximab or anti-TNFa
- •therapy per local prescribing information.
- •7. Taken any disallowed therapies as noted in Section 6.5, Concomitant
- •Therapy before the planned first dose of study intervention.
- •8. Received an investigational vaccine or used an invasive investigational
- •medical device within 3 months before the planned first dose of study
- •intervention or is currently enrolled in an investigational study.
- •9. Pregnant, or breast-feeding, or planning to become pregnant while
- •enrolled in this study or within 6 months after the last dose of study
- •intervention.
- •10. Plans to father a child while enrolled in this study or within 6 months
- •after the last dose of study intervention.
- •11. Any condition for which, in the opinion of the investigator,
- •participation would not be in the best interest of the participant (eg,
- •compromise the well-being) or that could prevent, limit, or confound the
- •protocol-specified assessments
- •12. Had major surgery, (eg, requiring general anesthesia) within 3 months before screening, or will not have fully recovered from surgery,
- •or has surgery planned during the time the participant is expected to
- •participate in the study or within 3 months after the last dose of study
- •intervention administration.
- •13. Have UC limited to the rectum only or to <20% of the colon.
- •14. Presence of a stoma.
- •15. Presence or history of a fistula.
- •16. Have severe, fixed symptomatic stenosis of the large or small
- •17. 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
- •study intervention treatment.
- •18. Presence or history of colonic or small bowel obstruction within 6
- 另有 8 项未显示
研究者
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