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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2014 by Uprety Shraddha, Postgraduate Institute of Medical Education and Research.
Recruitment status was:  Active, not recruiting
Postgraduate Institute of Medical Education and Research
Information provided by (Responsible Party):
Uprety Shraddha, Postgraduate Institute of Medical Education and Research Identifier:
First received: October 4, 2013
Last updated: October 29, 2014
Last verified: October 2014
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.

Condition Intervention Phase
Drug: Rituximab and Cyclophosphamide IV
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Uprety Shraddha, Postgraduate Institute of Medical Education and Research:

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 [ 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

Secondary Outcome Measures:
  • 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.

Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: November 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rituximab
Inj Rituximab 1 gram IV given on day 0 and day 15
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
Drug: Rituximab and Cyclophosphamide IV


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01974518

Chandigarh, India, 160012
Post-graduate Institute of Medical Education and Research
Chandigarh, India, 160012
Sponsors and Collaborators
Uprety Shraddha
Postgraduate Institute of Medical Education and Research
Principal Investigator: Shraddha Uprety, MBBS Postgraduate Institute of Medical Education and Research
  More Information

Responsible Party: Uprety Shraddha, Junior Resident, Postgraduate Institute of Medical Education and Research Identifier: NCT01974518     History of Changes
Other Study ID Numbers: 9187-PG-2012
Study First Received: October 4, 2013
Last Updated: October 29, 2014

Keywords provided by Uprety Shraddha, Postgraduate Institute of Medical Education and Research:
Rituximab and IV cyclophosphamide combination
B cell re-population characteristics following Rituximab

Additional relevant MeSH terms:
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists processed this record on May 25, 2017