EUCTR2008-004564-40-CZ进行中（未招募）不适用
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK0 个研究点目标入组 200 人开始时间: 2009年1月23日最近更新:
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
- 200
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. Subject must be at least 18 years of age.
- •2. Males and females with clinical diagnosis of ulcerative colitis =3 months prior to entry into the study.
- •3. Subjects with active moderate to severe ulcerative colitis as defined by Mayo score of =6
- •4. Subjects with endoscopic sub-score of =2 on the Mayo score determined within 7 days of baseline.
- •5. If subjects are currently receiving the following treatment for ulcerative colitis, they are eligible, providing they are on stable dose for the required period of time:
- •Oral 5-ASA or sulfasalazine stable dose for at least 2 weeks prior to baseline and during the study treatment period.
- •Oral corticosteroids (prednisolone =30 mg/day or less or equivalent) stable dose for at least 2 weeks prior to baseline.
- •6. Subjects with no evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined by the following:
- •A negative Mantoux Purified Protein Derivative (PPD) skin test result (=5 mm of induration) or negative QuantiFERON TB Gold (QFT Gold test) performed within the 3 months prior to screening (in subjects with a history of Bacille Calmette Guérin (BCG) vaccination, QFT Gold test or T-Spot test is strongly recommended).
- •A chest radiograph (taken within the 3 months prior to screening) without changes suggestive of active TB infection.
- •No history of either untreated or inadequately treated latent or active TB infection.
- •7. Subjects willing to use double contraception during the study treatment period and until completion of follow-up procedures:
- •If the subject is a sexually active woman of childbearing potential, she and her male partner are required to simultaneously use 2 effective contraceptive methods. Female subjects who wish to use non-hormonal contraception must have done so for at least 14 days prior to the first dose of study medication.
- •Non-vasectomized males with female partners of child bearing potential must be willing to use a condom in addition to having their female partner use another form of contraception.
- •8. Subjects receiving non prohibited concomitant medications for any reason, must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half lives (whichever is longer) prior to first study dose.
- •9. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •10. Evidence of a signed and dated informed consent document(s) indicating that the subject has been informed of all pertinent aspects of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn’s disease.
- •2. Subjects with ulcerative colitis, which is confined to a proctitis (distal 15 cm or less).
- •3. Treatment naïve subjects diagnosed with ulcerative colitis (without previous exposure to treatment).
- •4. Subjects displaying clinical signs of ischemic colitis, fulminant colitis or toxic megacolon.
- •5. Subject who have had surgery as a treatment for ulcerative colitis or likely to require surgery during the study period.
- •6. Subjects who have an evidence of pathogenic bowel infection.
- •7. Subjects receiving the following therapy:
- •Azathioprine/6-mercaptopurine, methotrexate within 7 days prior to baseline.
- •Cyclosporine, mycophenolate, tacrolimus within 4 weeks prior to baseline.
- •Interferon therapy within 8 weeks prior to baseline.
- •Anti-TNFa therapy within 8 weeks prior to baseline.
- •Intravenous corticosteroids or rectally administered formulation of corticosteroids or 5-ASA within 2 weeks prior to baseline.
- •8. Subjects with evidence of hematopoietic disorders:
- •Hemoglobin levels <9.0 g/dL or hematocrit <30% at screening visit or within the 3 months prior to baseline.
- •An absolute white blood cell (WBC) count of less than 3000 per cubic mm or ANC of less than 1200 per cubic mm at screening visit or within the 3 months prior to baseline.
- •Thrombocytopenia, as defined by a platelet count less than 100,000 per cubic mm at screening visit or within the 3 months prior to baseline.
- •9. Subjects with evidence of total bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 2 times the upper limit of normal at screening visit.
- •10. Subjects with eGFR =40 ml/min based on Cockcroft-Gault calculation.
- •11. Subjects with current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease.
- •12. Subjects with clinically significant infections currently or within 6 months of baseline (eg those requiring hospitalization or parenteral antimicrobial therapy or opportunistic infections), or those with a history of more than one episode of herpes zoster, a history (single episode) of disseminated zoster, a history of any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the study or any infection requiring antimicrobial therapy within 2 weeks of screening.
- •13. Subjects who may have current immunization with any live virus vaccine or history of immunization with any live virus vaccine within 8 weeks of baseline.
- •14. Subjects who may have, during the 8 weeks of treatment and for 8 weeks following completion of study treatment, routine household contact with individuals who have received:
- •a. FluMist® (intranasal influenza vaccine) within 1 week of such contact;
- •b. attenuated rotavirus vaccine within 10 days of such contact;
- •c. varicella or attenuated typhoid fever vaccine within 4 weeks of such contact; or
- •d. oral polio vaccine within 6 weeks of such contact.
- •15. Subjects with a first-degree relative with a hereditary immunodeficiency.
- •16. History of any lymphoproliferative disorder (such as EBV-related lymphoproliferative disorder, as reported in some subjects on other immunosuppressive drugs), history of lymphoma, leukemia, myeloproliferative disorders, multiple myeloma, or signs and symptoms suggestive of current lymphatic disease.
- •17. Any prior treatment with lymphocyte
研究者
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