EUCTR2010-023034-23-IT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 RESPONDERS(ANDANTE) - ANDANTE
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
- 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
- •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
- •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,
- 另有 4 项未显示
排除标准
- •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)
- 另有 5 项未显示
研究者
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