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

Primary Purpose

Pemphigus

Status

Unknown status

Phase

Phase 3

Locations

India

Study Type

Interventional

Intervention

Rituximab and Cyclophosphamide IV

About this trial

This is an interventional treatment trial for Pemphigus focused on measuring Pemphigus, Rituximab, Rituximab and IV cyclophosphamide combination, B cell re-population characteristics following Rituximab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

PGIMER
Post-graduate Institute of Medical Education and Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Rituximab

Combination of Rituximab and Cyclophosphamide IV

Arm Description

Inj Rituximab 1 gram IV given on day 0 and day 15

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01974518

First Posted

October 4, 2013

Last Updated

October 29, 2014

Sponsor

Uprety Shraddha

Collaborators

Postgraduate Institute of Medical Education and Research

1. Study Identification

Unique Protocol Identification Number

NCT01974518

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Unknown status

Study Start Date

November 2013 (undefined)

Primary Completion Date

June 2015 (Anticipated)

Study Completion Date

June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Uprety Shraddha

Collaborators

Postgraduate Institute of Medical Education and Research

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pemphigus

Keywords

Pemphigus, Rituximab, Rituximab and IV cyclophosphamide combination, B cell re-population characteristics following Rituximab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Rituximab

Arm Type

Active Comparator

Arm Description

Inj Rituximab 1 gram IV given on day 0 and day 15

Arm Title

Combination of Rituximab and Cyclophosphamide IV

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Rituximab and Cyclophosphamide IV

Primary Outcome Measure Information:

Title

Description

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

Time Frame

upto 9 months

Secondary Outcome Measure Information:

Title

Study the characteristics of B cell depletion and repopulation following IV rituximab and combination of IV cyclophosphamide with IV rituximab.

Description

Time Frame

upto 9 months

Other Pre-specified Outcome Measures:

Title

To study the difference in relapse rate

Time Frame

upto 9 months

Title

to study the total cumulative dose of corticosteroids adminstered and adjuvants required among patients of the 2 treatment groups

Time Frame

upto 9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shraddha Uprety, MBBS

Organizational Affiliation

Postgraduate Institute of Medical Education and Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

PGIMER

City

Chandigarh

ZIP/Postal Code

160012

Country

India

Facility Name

Post-graduate Institute of Medical Education and Research

City

Chandigarh

ZIP/Postal Code

160012

Country

India

12. IPD Sharing Statement

Learn more about this trial

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

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