EUCTR2010-023034-23-GR进行中（未招募）不适用
A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 INSUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
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
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- •1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- •2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •3. Male and/or female subjects between the ages of =18 and =75 years.
- •4. Subjects must have failed or are intolerant to anti TNFs
- •Relapsed after at least 1 anti TNF.
- •Primary non-responder to at least 1 anti TNF (maximum 50% of subjects).
- •Intolerant to at least 1 anti TNF
- •Other – Discontinued at least 1 anti TNF regimen for other reasons.
- •(Note: the anti TNF failure type is one of the stratification factors in this study. Primary non responders will be limited up to 50% of total enrollment by stratification. Intolerant subjects are those not meeting one of the prior 2 categories)
- •5. Active moderate to severe ileal (terminal ileum), ileocolic, or colonic CD (CDAI scores =220 to =450), despite use of mesalamine (5 ASAs), and/or immunosupressants (AZA, 6 MP, and MTX) (May continue use of 5 ASAs, AZA, MTX and 6 MP in this trial; dose must be stable 4 weeks prior to screening visit).
- •(Note: the background immunosuppressant therapy type (AZA, 6MP, MTX or none) is another stratification factor in this study.)
- •6. hsCRP =5 mg/L.
- •7. Ulcerations demonstrated by colonoscopy performed during screening as defined by SES CD assessment (Colonoscopy to be completed after signing ICD and verification of eligible lab values).
- •8. All women of childbearing potential (WOCBP) must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result at baseline and throughout the duration of the study.
- •WOCBP are defined as women who are biologically capable of becoming pregnant, including women who are using contraceptives or whose sexual partners are either sterile or using contraceptives.
- •Women of non childbearing potential (WONCBP) are defined as either postmenopausal (history of amenorrhea for =52 weeks and confirmation by FSH level) or who are surgically sterile, such as after hysterectomy, bilateral oophorectomy, or tubal ligation (procedure performed =52 weeks before screening). This information must be documented in the subject's source documents.
- •WONCBP do not require a serum and urine pregnancy test.
- •9. WOCBP who have sexual intercourse with a non-surgically sterilized male must agree and commit to the use of the following highly effective methods of contraception for the duration of the study (defined as the time of the signing of the ICF through the conclusion of subject participation or for approximately 9 months from the last dose of investigational product for any subject who discontinues early from the study). Female subjects who meet the criteria will be advised to continue a highly effective method of birth control for an additional 40 weeks at the conclusion of study participation due to the possible presence of low levels of investigational product. Contraceptive methods considered acceptable for use in this study include:
- •Established use [=2 months prior to the screening visit] of oral, injected, transdermal or implanted hormonal methods of contraception.
- •Hormonal contraception must be accompanied by the use of a physical barrier method su
排除标准
- •Subjects presenting with any of the following will not be included in the study:
- •Medical History
- •1. Pregnant or breastfeeding women.
- •2. CD with active fistulae or abscess. Subjects with a prior history of fistulae or abdominal or perineal abscess or have not completed the usual CT/MR work up for extent of disease must have CT or MR enterography during screening to exclude active fistulae or abdominal or perineal abscess prior to study entry. MR enterography may be preferred since it does not have radiation exposure.
- •3. Subjects who had a colectomy with ileorectal anastomosis, or multiple small bowel resections resulting in clinically relevant short bowel syndrome with clinically significant malabsorption or need for TPN, in the opinion of the Investigator.
- •4. Previous bowel surgery resulting in a stoma or surgical bowel resection within the past 3 months.
- •5. History of diverticulitis or symptomatic diverticulosis.
- •6. Pre existing demyelinating disorder such as multiple sclerosis, new onset seizures, unexplained sensory, motor, or cognitive, behavioral or neurological deficits.
- •7. Known history of HIV based on documented history with positive serological test, or positive HIV serologic test at screening, tested at the site’s local lab. (Note: a documented negative HIV test within 12 months of screening is acceptable and does not need to be repeated).
- •8. Significant concurrent medical conditions at the time of screening or baseline visit, including, but not limited to, the following:
- •Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, GI, endocrine, pulmonary, immunologic [eg, Felty syndrome], or local active infection/infectious illness) that, in the investigator’s judgment, will substantially increase the risk to the subject if he or she participates in the study.
- •Cancer or history of cancer or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence).
- •Class III or IV congestive heart failure as defined by the New York Heart Association.
- •Acute coronary syndrome (eg, myocardial infarction, unstable angina pectoris) and any history of significant cerebrovascular disease within 24 weeks before screening.
- •9. Any major elective surgery scheduled to occur during the study.
- •10. Presence of a transplanted organ.
- •11. Prior evidence of liver injury or toxicity due to methotrexate.
- •Physical and Laboratory Findings
- •12. Abnormal findings on the a chest x ray film, performed routinely before initiating a new biologic therapy, such as presence of tuberculosis (TB), general infections, heart failure, or malignancy. (Chest x ray examination may be performed up to 12 weeks prior to study entry. Documentation of the official reading must be located and available in the source documentation).
- •13. Any history or current evidence of latent or active tuberculosis infection, evidence of prior or currently active tuberculosis by chest radiography, residing with or frequent close contact with individual(s) with active tuberculosis. Subjects who have a positive Mantoux (PPD) tuberculin skin test or a positive Interferon Gamma Release Assay performed locally (the following are acceptable assays: QuantiFERON® TB Gold test (QFT G), QuantiFERON® TB Gold In Tube test (QFT GIT) and T SPOT® TB test) during screening or within 12 weeks prior to randomization.
研究者
相似试验
进行中（未招募）
不适用
Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatmentsMedDRA version: 14.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersCrohn's DiseaseEUCTR2010-023437-30-ATPfizer Inc., 235 East 42nd Street, New York, NY 10017240
进行中（未招募）
不适用
A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Ev aluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate ResponsersCrohn's Disease (active moderate to severe)MedDRA version: 16.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2010-023034-23-CZPfizer Inc.220
进行中（未招募）
不适用
Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatmentsMedDRA version: 16.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersCrohn's DiseaseEUCTR2010-023437-30-SKPfizer Inc., 235 East 42nd Street, New York, NY 10017240
进行中（未招募）
不适用
A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate ResponsersCrohn's Disease (active moderate to severe)MedDRA version: 16.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2010-023034-23-SEPfizer Inc., 235 East 42nd Street, New York, NY 10017220
进行中（未招募）
不适用
A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Ev aluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate ResponsersCrohn's Disease (active moderate to severe)MedDRA version: 17.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2010-023034-23-DKPfizer Inc., 235 East 42nd Street, New York, NY 10017220