EUCTR2011-001733-16-CZ进行中（未招募）不适用
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc.
- 入组人数
- 275
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
- •Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- •1. Male or female subjects between the ages of =18 and =75 years at screening.
- •2. Subjects with documented clinical diagnosis of Crohn’s disease (CD) for at least 6 months prior to screening.
- •3. Subjects with active moderate to severe ileal, ileocolic, or colonic CD defined by a baseline score of Crohn’s Disease Activity Index (CDAI) of =220 to =450 at baseline.
- •4. Subjects with a history of inadequate treatment response or intolerance (as defined by the Investigator) to at least one of the following therapies for Crohn’s disease:
- •Corticosteroids.
- •Azathioprine/6-Mercaptopurine.
- •Methotrexate.
- •Anti-TNF therapy (Infliximab; Adalimumab; Certolizumab pegol).
- •5. Subjects currently receiving any of the following treatments for Crohn’s disease are eligible provided they are on stable dose for designated period of time and throughout the study:
- •Oral 5-ASA or sulfasalazine stable dose for at least 4 weeks prior to baseline.
- •Oral corticosteroids (prednisolone up to 30 mg/day; budesonide up to 9 mg/day) stable dose for at least 2 weeks prior to baseline.
- •Chronic treatment for Crohn’s disease with antibiotics (e.g. metronidazole, rifaximin) stable dose for at least 2 weeks prior to baseline.
- •Rectally administered formulation of corticosteroids or 5-ASA stable dose for at least 2 weeks prior to baseline.
- •Seton placement before enrollment must remain in place during the study.
- •6. Subjects with presence of ulceration at screening/baseline colonoscopy as documented by the Simple Endoscopic Score for Crohn’s Disease (SES-CD): aphthous ulcers (0.1 to 0.5 cm), large ulcers (0.5 to 2 cm), or very large ulcers (>2 cm).
- •7. No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined by all of the following:
- •A chest radiograph taken at or within the 3 months prior to screening, without changes suggestive of active TB infection as determined by a qualified radiologist.
- •No history of either untreated or inadequately treated latent or active TB infection.
- •If a subject has previously received an adequate course of therapy for either latent (e.g., 9 months of isoniazid in a locale where rates of primary multi drug resistant TB infection are <5% or an acceptable alternative regimen) or active (acceptable multi drug regimen) TB infection, neither a PPD test nor a QFT G test is needed, but a negative chest radiograph must still be obtained if not performed within 3 months prior to screening. Documentation of adequate treatment for TB will be obtained prior to first dose of study drug.
- •A subject who is currently being treated for active TB infection is to be excluded.
- •A subject who is currently being treated for latent TB infection can only be enrolled with confirmation of current incidence rates of multi-drug resistant TB infection in the locale, documentation of an adequate treatment regimen, and with prior approval by the Sponsor.
- •8. Women of childbearing potential must test negative for pregnancy prior to study enrolment.
- •9. Sexually active females of childbearing potential are required to use adequate contraceptive methods during the study period and until completion of the follow-up procedu
排除标准
- •1.Diagnosis of indeterminate colitis, UC, or clinical findings suggestive of UC. 2.Subjects diagnosed with Crohn's disease but without previous exposure to treatment or having failed or been intolerant to treatment solely with 5 ASA containing compounds. 3.Subjects receiving treatment for Crohn's disease (see protocol for list of treatments). 4.Other investigational or marketed biologics with immunomodulatory properties within 3 months prior to baseline. 5.Subjects who have previously received natalizumab, or any anti adhesion molecule, within 1 year prior to baseline. 6.Leukocyte apheresis including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months. 7.Subjects who have previously participated in any study of tofacitinib. 8.Participation in other interventional clinical studies within 3 months prior to baseline and/or during study. 9.History of symptomatic obstructive strictures unless the stricture has been surgically treated or treated with dilation without recurrence of symptoms for at least 6 months prior to enrollment, or an active ostomy. 10.History of total colectomy or subtotal colectomy to the extent that it precludes the subject from having any formed stool, extensive small bowel resection (>100 cm) or short bowel syndrome. 11.History of bowel surgery within 6 months prior to baseline. 12.Subjects likely to require any type of surgery during the study period. 13.Fecal culture/toxin assay indicating presence of pathogenic infection. 14.Presence of active (draining) fistulae, intra-abdominal or perineal collection or abscess.15.Subjects on elemental diet used for treating Crohn's disease within 7 days from baseline. 16.Subjects with blood dyscrasias at screening. 17.Subjects with evidence of or suspected liver disease eg, liver injury due to methotrexate or primary sclerosing cholangitis. 18.Subjects with estimated GFR <40 ml/min at screening, based on Cockcroft Gault calculation. 19.Subjects with total bilirubin, AST or ALT more than 1.5 times the upper limit of normal at screening. 20.Subjects with current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease. 21.Subjects who
- •have been vaccinated with any live or attenuated virus vaccine within 6 weeks of baseline or scheduled to receive live virus vaccination during study period and for 6 weeks after last dose of study drug. 22.Subjects with history of any lymphoproliferative disorder, history of lymphoma, leukemia, myeloproliferative disorders, multiple myeloma, or signs and symptoms suggestive of current lymphatic disease. 23.Subjects with clinically significant infections currently or within 6 months of baseline, a history of any infection requiring antimicrobial therapy within 2 weeks of baseline, or a history of any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the study. 24.Subjects with a history of more than one episode of herpes zoster, a history of disseminated herpes zoster or disseminated herpes simplex. 25.Subjects with prior treatment with lymphocyte depleting agents/therapies. Subjects who have received rituximab or other selective B lymphocyte depleting agents are eligible if they have not received such therapy for at least 1 year prior to baseline. 26.Subjects with any condition possibly affecting oral drug absorption. 27.Women who are pre
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