Health Condition 1: K509- Crohns disease, unspecified Health Condition 2: null- Patients with moderate to severe Crohn’s disease
Conditions
Interventions
Intervention1: Infliximab: Infimab™ 5 mg/kg will be administered as intravenous infusion over a period of not less than 2 hours in all eligible patients
Control Intervention1: NA: NA As it is a single
Sponsors
Reliance Life Sciences Pvt Ltd
Eligibility
Inclusion 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
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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidences of adverse events occurring during the studyTimepoint: Incidences of adverse events occurring during the study till week 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactMr. Ganesh Bagul
Reliance Life Sciences Pvt. Ltd. (RLS)
Outcome results
None listed