The post marketing clinical research on drug Infliximab in patients with moderate to severe Crohn’s disease
- Conditions
- Health Condition 1: K509- Crohns disease, unspecifiedHealth Condition 2: null- Patients with moderate to severe Crohn’s disease
- Registration Number
- CTRI/2018/03/012298
- Lead Sponsor
- Reliance Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
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.
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.
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
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidences of adverse events occurring during the studyTimepoint: Incidences of adverse events occurring during the study till week 14
- Secondary Outcome Measures
Name Time Method Change in Crohns disease activity index (CDAI) from base line to week 14Timepoint: week 14;Clinical Response rate at week 14Timepoint: week 14;Remission rate at week 14Timepoint: week 14