CTRI/2018/03/012298已完成4 期
A prospective, multi-centre, open label, phase IV studyto evaluate safety and efficacy profile of InfimabTM inpatients with moderate to severe Crohn’s disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •Patients aged between 18 to 65 yrs Both inclusive
- •Patient with confirmed diagnosis of Crohns disease since at least 6 months and eligible to be administered infliximab as per prescribing information of Infliximab innovator.
- •Patients with moderate to sever active Crohns Disease defined as Crohns disease activity index (CDAI) score of at least 220
- •Women with Childbearing potential must agree to use adequate contraception.
- •Patient will to provide written informed consent.
排除标准
- •Patients with hypersensitivity to infliximab or any of its components
- •Pregnant or lactating females
- •Presence of serious or active infection due to bacteria, fungi, viruses or other
- •opportunistic pathogens
- •History of serious infection, which caused hospitalization within 6 months prior to
- •randomization or other severe or chronic infection (such as sepsis, abscess or
- •opportunistic infections, invasive fungal infection such as histoplasmosis, or a history
- •of recurrent herpes zoster or other chronic or recurrent infection) or a past diagnosis
- •without sufficient documentation of complete resolution following treatment.
- •Infection requiring parenteral antibiotic treatment within 4 weeks of randomization.
- •Patients with history of any malignancy including lymphomas or presence of any
- •premalignant lesions
- •Patients with heart failure (New York Heart Association class III or IV)
- •Patients with known hematological disorders, demyelinating disease or lupus-like
- •Patients with clinically significant liver disease
- •Known cases of HIV, Hepatitis B or Hepatitis C infection
- •Active TB. Also excluded are subjects who have evidence of latent TB [evidence of
- •tuberculosis based on chest X rays, tuberculin skin (Mantoux) test or other
- •tuberculosis test performed during screening] without adequate therapy for TB
- •completed prior to first infusion of Study Medication. Also excluded are subjects with
- •evidence of an old or latent TB infection without documented adequate therapy, if
- •they will not be treated with antitubercular therapy during the study. Subjects with a
- •current close contact with an individual with active TB will also be excluded.
- •Additionally, subjects who have completed treatment for active TB within the previous
- •2 years are explicitly excluded from the study. Subjects with a household member
- •who has a history of active pulmonary TB, which has been treated, should have had
- •a thorough evaluation for TB prior to study enrolment as recommended by a local
- •infectious disease specialist or published local guidelines of TB control agencies.
- •Also excluded are subjects with opportunistic infections including, but not limited to,
- •evidence of active cytomegalovirus, active pneumocystis carinii, aspergillosis, or
- •atypical mycobacterial infection, etc., within the previous 6 months.
- •12. Patients with any condition that might make it difficult for patients to participate in the
- •study or that might affect interpretation of results of the study, at the discretion of
- •Investigator.
- •Participation in any clinical study of an investigational product within previous 3
- •Current signs or symptoms of significant, progressive or uncontrolled renal, hepatic,
- •hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral
- •disease that renders the patient incapable of participating in the study.
研究者
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