Comparative Study of Rituximab Versus Combination of Rituximab and Intravenous Cyclophosphamide in Severe Pemphigus

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01974518
• Date of registration: 04/10/2013
• Prospective Registration: Yes
• Primary sponsor: Uprety Shraddha
• Public title: Comparative Study of Rituximab Versus Combination of Rituximab and Intravenous Cyclophosphamide in Severe Pemphigus
• Scientific title: A PILOT STUDY TO ASSESS THE EFFICACY OF RITUXIMAB VERSUS COMBINATION OF RITUXIMAB AND INTRAVENOUS CYCLOPHOSPHAMIDE IN THE TREATMENT OF REFRACTORY PEMPHIGUS
• Date of first enrolment: November 2013
• Target sample size: 20
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01974518
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: Shraddha Uprety, MBBS
• Affiliation: PGIMER

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Pemphigus

Intervention(s)

Drug: Rituximab and Cyclophosphamide IV

Primary Outcome(s)

Study the clinical efficacy of IV rituximab vs IV rituximab and IV cyclophosphamide combination for treatment of refractory pemphigus in terms of early and late end points as defined by the international pemphigus committee [Time Frame: upto 9 months]

Secondary Outcome(s)

Study the characteristics of B cell depletion and repopulation following IV rituximab and combination of IV cyclophosphamide with IV rituximab. [Time Frame: upto 9 months]

Secondary ID(s)

9187-PG-2012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Postgraduate Institute of Medical Education and Research