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临床试验/EUCTR2006-003371-13-DE
EUCTR2006-003371-13-DE进行中（未招募）1 期

A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 04 incorporating Amendments 02, 03, 08 & 09 (v1.0, date 09-Mar-2009) + administrative letters 01 & 02. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006).

Bristol-Myers Squibb International Corporation0 个研究点目标入组 709 人开始时间: 2006年12月14日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
709
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

  • •1) Signed written informed consent
  • •2) Subject must have had CD for at least 3 months from the time of initial diagnosis.
  • •Active CD must be confirmed by radiologic, endoscopic or histologic evidence within
  • •the previous 12 months. If previous confirmation of diagnosis is not available or if
  • •previous diagnosis is not deemed conclusive at time of screening, CD diagnosis
  • •should be confirmed by endoscopy, radiology or histology.
  • •3) Subjects must satisfy at least one of the following criteria:
  • •a/ In the past had an inadequate response to at least 1 of the following treatments:
  • •i) oral prednisone >= 40 mg/day (or equivalent) or budesonide >= 9 mg/day for at
  • •least 2 weeks and/or
  • •ii) immunosuppressants (azathioprine >= 2 mg/kg/day or 6-mercaptopurine >=
  • •1.0 mg/kg/day [or documentation of a therapeutic concentration of
  • •6-thioguanine nucleotide] or methotrexate >= 15 mg/week) for at least 12
  • •weeks and/or
  • •iii) an approved anti-TNF agent at an approved labeled dose for at least 8 weeks
  • •b/ Have been intolerant to one of the above mentioned treatments (e.g., unable to
  • •achieve doses or treatment durations because of dose limiting side effects [e.g.,
  • •leukopenia, psychosis, uncontrolled diabetes, elevated liver enzymes]).
  • •c/ Currently receiving one or more of the following treatments:
  • •i) oral prednisone >= 20 mg/day (or equivalent) or budesonide >= 3 mg/day for at
  • •least 4 weeks and/or
  • •ii) immunosuppressants [azathioprine >= 2 mg/kg/day or 6-mercaptopurine >=
  • •1.0 mg/kg/day, (or documentation of a therapeutic concentration of 6-thioguanine
  • •nucleotide)] for at least 12 weeks.
  • •Subjects currently receiving and tolerating the above mentioned treatments (with
  • •the exception of anti-TNF agents) should continue their treatment (see Drug Stabilization Requirements, Protocol Section 6.4.2.1). Subjects who had an inadequate response and/or intolerance to anti-TNF treatment must have had their last dose at least 8 weeks prior to entry into the Induction Period.
  • •Acceptable documentation of inadequate response or intolerance in subjects include 1 or more of the following: medical records; letters provided by the referring physician; other referral documents (e.g., insurance authorization forms), provided they contain the relevant information to support the subject’s ‘inadequate response’ and/or ‘intolerance’ to the designated therapy.
  • •In all circumstances, it should be established that discontinuation of the designated
  • •treatments was primarily due to lack of efficacy or intolerance (e.g., not due to
  • •unavailability of the drug).
  • •Subjects in clinical remission should not discontinue CD therapy that is maintaining
  • •clinical remission, for the purpose of meeting eligibility requirements to enroll into this
  • •4) Moderate to severe CD as measured by a CDAI score >= 220 and =< 450
  • •5) hsCRP > Upper Limit of Normal (ULN)
  • •6) Oral corticosteroid treatment must have been reduced to the equivalent of =< 30 mg prednisone or =< 9 mg budesonide daily at a stable dose for at least 2 weeks prior to entry into the Induction Period
  • •7) Oral aminosalicylates should be at a stable dose for at least 2 weeks prior to entry into the Induction Period
  • •8) Azathioprine, 6-mercaptopurine and methotrexate should be at a stable dose for at least 8 weeks prior to entry into the Induction Period
  • •9) Men and women, ages >= 18
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years)

排除标准

  • •1)WOCBP unwilling or unable to use an acceptable method to avoid pregnancy for entire study period & for up to 10 weeks after study
  • •2)WOCBP using a prohibited contraceptive method
  • •3)pregnant or breastfeeding women
  • •4)Women with positive pregnancy test on enrollment or prior to study drug administration
  • •5)Diagnosis of Ulcerative or Indeterminate Colitis
  • •6)CD isolated to stomach, duodenum, jejunum, or perianal region without colonic or ileal involvement
  • •7)Suspected or diagnosed intra-abdominal or perianal abscess at screening
  • •8)Known strictures or stenosis (without inflammatory component) leading to symptoms or obstruction
  • •9)Current evidence of fulminant colitis, toxic megacolon or bowel perforation
  • •10)Current stoma or current need for colostomy or ileostomy. Use of seton for perianal disease
  • •11)Previous total proctocolectomy or subtotal colectomy with ileorectal anastomosis
  • •12)Surgical bowel resection <6 months before screening
  • •13)Extensive small bowel resection or known short bowel syndrome
  • •14)Primary sclerosing cholangitis
  • •15)Currently receiving total parenteral nutrition
  • •16)Past/current evidence of definite low grade or high grade colonic dysplasia
  • •17)Subjects who are scheduled or anticipate the need for surgery aside from
  • •dermatologic procedures
  • •18)History of clinically significant drug or alcohol abuse
  • •19)Concomitant illness, likely to require systemic glucocorticosteroid therapy during study (e.g. moderate to severe asthma)
  • •20)Current symptoms of severe, progressive, or uncontrolled renal, hepatic,
  • •hematological, pulmonary, cardiac, neurological, ophthalmologic or cerebral disease
  • •Concomitant medical conditions that might place subject at unacceptable risk for participation in study
  • •21)Subjects with a history or current evidence of malignancies; specifically subjects with
  • •a)history of cancer within last 5 years (other than NMSC cancers cured by local resection) or
  • •b)evidence of malignancies (including that detected by screening procedures), or
  • •c)signs of possible malignancies detected by screening procedures for which the
  • •workup to exclude malignancy has not been completed.
  • •The following subjects may be enrolled; those with
  • •a)existing NMSC cancers which have been entirely removed prior to enrollment, or
  • •b)carcinoma in situ treated with definitive surgical intervention
  • •c)no evidence of malignancy upon completion of evaluation prompted by suspicious screening procedure.
  • •22)Subjects at risk for tuberculosis
  • •23)Subjects with any serious bacterial infection within last 3 months, unless treated & resolved with antibiotics, or any chronic bacterial infection
  • •24)Female subjects who have had breast cancer screening that is suspicious for
  • •malignancy, & in whom the possibility of malignancy cannot be reasonably
  • •excluded following additional clinical, laboratory or other diagnostic evaluations (Protocol Section 7.3.2.4)
  • •25)Subjects with evidence of active or latent bacterial or viral infections at the time of potential enrollment, including subjects with evidence of HIV, Hepatitis B or Hepatitis C infection detected during screening
  • •26)Subjects with herpes zoster or cytomegalovirus that resolved <2 months before signing ICF
  • •27)Subject who have received any live vaccines within 3 months of the anticipated first dose of study medication or who will have need of a live vaccine at any time following entry in Induction Period (IP)
  • •28)Subject with a clinically significant abnormal chest x-ray at screening
  • •29)Positive stool culture for enteric patho

研究者

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