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

• ClinicalTrials.gov Identifier: NCT01974518
• Recruitment Status: Unknown
• First Posted: November 1, 2013
• Last Update Posted: October 30, 2014
• Sponsor: Uprety Shraddha
• Collaborator: Postgraduate Institute of Medical Education and Research
• Information provided by (Responsible Party): Uprety Shraddha, Postgraduate Institute of Medical Education and Research

Tracking Information

• First Submitted Date: October 4, 2013
• First Posted Date: November 1, 2013
• Last Update Posted Date: October 30, 2014
• Study Start Date: November 2013
• Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 27, 2013)

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 ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 27, 2013)

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 ]

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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: October 27, 2013)

• To study the difference in relapse rate [ Time Frame: upto 9 months ]
• to study the total cumulative dose of corticosteroids adminstered and adjuvants required among patients of the 2 treatment groups [ Time Frame: upto 9 months ]

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Treatment
• Condition: Pemphigus
• Intervention: Drug: Rituximab and Cyclophosphamide IV

Study Arms

• Active Comparator: Rituximab
  Inj Rituximab 1 gram IV given on day 0 and day 15
  Intervention: Drug: Rituximab and Cyclophosphamide IV
• Active Comparator: Combination of 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
  Intervention: Drug: Rituximab and Cyclophosphamide IV

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 27, 2013): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2015
• Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT01974518
• Other Study ID Numbers: 9187-PG-2012
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Uprety Shraddha, Postgraduate Institute of Medical Education and Research
• Original Responsible Party: Same as current
• Current Study Sponsor: Uprety Shraddha
• Original Study Sponsor: Same as current
• Collaborators: Postgraduate Institute of Medical Education and Research

Investigators

• Principal Investigator: Shraddha Uprety, MBBS; Postgraduate Institute of Medical Education and Research

• PRS Account: Postgraduate Institute of Medical Education and Research
• Verification Date: October 2014