Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue
Conditions
Interventions
None listed
Sponsors
Reliance Life Sciences Pv Ltd
Eligibility
Inclusion criteria
Inclusion criteria: The patient inclusion will be sole decision of the Dermatologists according to his routine practice. Minimum inclusion criteria clinically required can be as follows which will be at solediscretion of the Dermatologists. Adults (18 through 70 years of age) with clinically-documented diagnosis of moderate to severe Pemphigus vulgaris
Exclusion criteria
Exclusion criteria: Pregnant women, nursing mothers or a planned pregnancy within 18 months,Allergy to rituximab and any of the excipients of RituxiRelTM RN (rituximab), Active TB. Also excluded are patients who have evidence of latent TB [evidence of tuberculosisbased on chest X rays, QuantiFERON®-TB Gold test and other TB tests performed during screening]. Also excluded are patients with opportunistic infections including, but not limited to,evidence of active cytomegalovirus, active pneumocystis carinii, aspergillosis, or typical mycobacterial infection, etc., within the previous 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All adverse events (AEs) will be recorded and reported during all the follow up visits. All serious ADRs, including infections and malignancy,also occurrence of immediate or late infections, especially tuberculosis, Hepatitis, pneumonia, Pneumocystis jiroveci pneumonia, cytomegalovirus infection, and sepsis and to specific important ADRs that included malignant neoplasm, demyelination, congestive heart failure, injection site reaction, and lupus.Timepoint: All adverse events (AEs) will be recorded and reported during all the follow up visits at 1 month for one year followed by every 3 months for the 2nd year. | — |
Secondary
| Measure | Time frame |
|---|---|
| All adverse events (AEs) will be recorded and reported during all the follow up visits. All serious ADRs, including infections and malignancy,also occurrence of immediate or late infections, especially tuberculosis, Hepatitis, pneumonia, Pneumocystis jiroveci pneumonia, cytomegalovirus infection, and sepsis and to specific important ADRs that included malignant neoplasm, demyelination, congestive heart failure, injection site reaction, and lupus.Timepoint: Every month follow up of safety parameters upto 1 year and then every 3 months upto 2nd year all safety parameters identified by physician will be recorded | — |
Countries
India
Contacts
Public ContactDr Manoj Naik
Reliance Life Sciences Pvt Ltd
Outcome results
None listed