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

Pemphigus Clinical Trial

Official title:

A PILOT STUDY TO ASSESS THE EFFICACY OF RITUXIMAB VERSUS COMBINATION OF RITUXIMAB AND INTRAVENOUS CYCLOPHOSPHAMIDE IN THE TREATMENT OF REFRACTORY PEMPHIGUS

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01974518
• Other study ID #: 9187-PG-2012
• Status: Active, not recruiting
• Phase: Phase 3
• First received: October 4, 2013
• Last updated: October 29, 2014
• Start date: November 2013
• Est. completion date: June 2015

Study information

• Verified date: October 2014
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effectiveness of rituximab alone vs combination of rituximab and cyclophosphamide in the treatment of pemphigus not responding adequately to routine medications.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pemphigus

Intervention

Drug:
• Rituximab and Cyclophosphamide IV

Locations

Country	Name	City	State
India	PGIMER	Chandigarh
India	Post-graduate Institute of Medical Education and Research	Chandigarh

Sponsors (2)

Lead Sponsor	Collaborator
Uprety Shraddha	Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To study the difference in relapse rate		upto 9 months	No
Other	to study the total cumulative dose of corticosteroids adminstered and adjuvants required among patients of the 2 treatment groups		upto 9 months	No
Primary	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	Primary outcome measures being; Time taken for control of disease activity; Time taken for achievement of partial remission; Time taken for achievement of complete remission	upto 9 months	No
Secondary	Study the characteristics of B cell depletion and repopulation following IV rituximab and combination of IV cyclophosphamide with IV rituximab.	Flowcytometric analysis of CD19+ve27-ve naïve B cells count, CD19+ve27+ve memory B cells count and CD24highCD38high transitional cell count will be performed at baseline, 3rd month, 6th month and 9th month.	upto 9 months	No