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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
Sponsored by
Uprety Shraddha
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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

First Posted
October 4, 2013
Last Updated
October 29, 2014
Sponsor
Uprety Shraddha
Collaborators
Postgraduate Institute of Medical Education and Research
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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
No

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
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
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
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.
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
No
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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