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
- 试验地点
- 22
- 主要终点
- Incidences of adverse events occurring during the study
研究概览
简要总结
This is a prospective, multi-centre, open label, phase IV study to evaluate safety and efficacy profile of InfimabTM in 100 patients with moderate to severe Crohn’s disease.
InfimabTM is a similar biological to innovator product developed by Reliance Life Sciences Pvt. Ltd. A phase III study conducted in patients with active rheumatoid arthritis on a stable dose of methotrexate demonstrated the comparable efficacy and safety profile of InfimabTM and the Innovator product.
InfimabTM has been approved by DCGI for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis and ulcerative colitis.
This is prospective, multi-centre, open label, phase IVstudy has been designed to evaluate the safety and efficacy of InfimabTMin adultpatients with moderately to severely active Crohn’s disease who have had aninadequate response to conventional therapy. As per the clinical evidencegathered patientswho do not respond by Week 14 are unlikely to respond with continued dosing andconsideration should be given to discontinue infliximab in these patients.Hence, the efficacy endpoints will be assessed at Week 14.
Study Population: Male or female patientsaged between 18to 65 years (both inclusive) with moderate to severe Crohn’s disease (CDAI scoreof at least 220).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
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 syndrome 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.
- •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 months.
- •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.
结局指标
主要结局
Incidences of adverse events occurring during the study
时间窗: Incidences of adverse events occurring during the study till week 14
次要结局
- Change in Crohns disease activity index (CDAI) from base line to week 14(week 14)
- Clinical Response rate at week 14(week 14)
- Remission rate at week 14(week 14)