跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/EUCTR2011-001733-16-NL
EUCTR2011-001733-16-NL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

Pfizer Inc.235 East 42nd Street, New York, NY 100170 个研究点目标入组 275 人开始时间: 2011年12月22日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症

试验速览

阶段
不适用
状态
进行中（未招募）
发起方
入组人数
275
研究概览入排标准研究者记录与标识符相似试验

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
  • •2. Subjects with documented clinical diagnosis of Crohn's disease 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
  • •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 (eg,
  • •metronidazole, rifaximin) stable dose for at least 2 weeks prior to
  • •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
  • •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
  • •A subject who is currently being treated for latent TB infection can
  • •only be enrolled with confirmation of current incidence rates of multi
  • 另有 6 项未显示

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 affecti

研究者

发起方
Pfizer Inc.235 East 42nd Street, New York, NY 10017

相似试验

进行中（未招募）
1 期
A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects with Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.Primary Generalised Tonic Clonic SeizuresMedDRA version: 16.0 Level: LLT Classification code 10034089 Term: Partial seizures NOS System Organ Class: 100000004852
EUCTR2010-023263-18-ESPfizer Inc 235 East 42nd Street, New York, NY10017 US219
进行中（未招募）
1 期
A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects with Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.
EUCTR2010-023263-18-GBPfizer Inc.219
进行中（未招募）
不适用
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER TRIAL OF PREGABALIN CONTROLLED RELEASE FORMULATION AS ADJUNCTIVE THERAPY IN ADULTS WITH PARTIAL ONSET SEIZURES - PROTOCOL A0081194Adjunctive (add on) therapy for adult subjects with partial onset seizures with or without secondary generalization.MedDRA version: 14.1Level: LLTClassification code 10048674Term: Partial seizures with secondary generalizationSystem Organ Class: 10029205 - Nervous system disorders
EUCTR2010-019035-35-BGPfizer Inc. 235 East 42nd Street, New York, NY 10017333
进行中（未招募）
1 期
MULTICENTRE STUDY OF THE EFFICACY AND SAFETY OF NICOTINAMIDE IN PATIENTS WITH FRIEDREICHS ATAXIA.Friedreich Ataxia
EUCTR2017-002163-17-ESRWTH Aachen University represented by the Rector himself, represented by the Dean of the Medical Faculty225
进行中（未招募）
不适用
A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s diseaseMedDRA version: 17.1Level: LLTClassification code 10011402Term: Crohn's disease (colon)System Organ Class: 100000004856Crohn's disease
EUCTR2011-001733-16-CZPfizer Inc.275