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

Phase 3

• Conditions: Pemphigus
• Interventions: Drug: Rituximab and Cyclophosphamide IV

• Registration Number: NCT01974518
• Lead Sponsor: Uprety Shraddha

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-04
• Study First Submitted QC: 2013-10-27
• Study Start: 2013-11
• Study First Posted: 2013-11-01
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-29
• Last Update Posted: 2014-10-30
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination of Rituximab and Cyclophosphamide IV	Rituximab and Cyclophosphamide IV	IV Rituximab 1gram on day 0 and 15 750 mg IV cyclophosphamide in 250 ml of NS over 2-3 hr on day 1 and day 16
Rituximab	Rituximab and Cyclophosphamide IV	Inj Rituximab 1 gram IV given on day 0 and day 15

Primary Outcome Measures

Name	Time	Method
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	upto 9 months	Primary outcome measures being; 1. Time taken for control of disease activity; 2. Time taken for achievement of partial remission; 3. Time taken for achievement of complete remission

Secondary Outcome Measures

Name	Time	Method
Study the characteristics of B cell depletion and repopulation following IV rituximab and combination of IV cyclophosphamide with IV rituximab.	upto 9 months	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.

Trial Locations

Locations (2)

PGIMER; 🇮🇳 Chandigarh, India

Post-graduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, India