Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT01974518
Eligibility Criteria:
Inclusion Criteria:
* Patients with the diagnosis of pemphigus based on clinical, histopathological and immunological features the following:
* Refractory disease defined as continuing extension of old lesions, development of new lesion, or failure of established lesions to begin to heal despite 3 weeks of therapy on 1.5 mg/kg/day of prednisolone or its equivalent with or without the concurrent use of cyclophosphamide 2mg/kg/day for 12 weeks or azathioprine 2.5 mg/kg/day for 12 weeks. Patients who fail to respond to 6 DCP/DP are also considered as refractory disease.
Exclusion Criteria:
* Infections- Hepatitis B, Hepatitis C, HIV, active tuberculosis or sepsis.
* Abnormal liver function tests and renal function tests
* Known cardiac arrhythmia or conduction abnormality
* Systolic ejection fraction \<40%
* Pregnancy and breast feeding
* Severely decreased bone marrow functions.
* Known history of bladder cancer or hemorrhagic cystitis
* Known allergy to cyclophosphamide
* Patients of reproductive age group who haven't completed their family
* Known hypersensitivity to murine proteins.
* Patients who do not consent for the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01974518
Study Brief:
Protocol Section:
NCT01974518