CTRI/2018/03/012298
Completed
Phase 4
A prospective, multi-centre, open label, phase IV studyto evaluate safety and efficacy profile of InfimabTM inpatients with moderate to severe Crohn’s disease
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: K509- Crohns disease, unspecifiedHealth Condition 2: null- Patients with moderate to severe Crohn’s disease
- Sponsor
- Reliance Life Sciences Pvt Ltd
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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