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

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ClinicalTrials.gov Identifier: NCT01974518
Recruitment Status : Unknown
Verified October 2014 by Uprety Shraddha, Postgraduate Institute of Medical Education and Research.
Recruitment status was:  Active, not recruiting
First Posted : November 1, 2013
Last Update Posted : October 30, 2014
Sponsor:
Collaborator:
Postgraduate Institute of Medical Education and Research
Information provided by (Responsible Party):
Uprety Shraddha, Postgraduate Institute of Medical Education and Research

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pemphigus Drug: Rituximab and Cyclophosphamide IV Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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 Start Date : November 2013
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pemphigus

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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:
  1. To study the difference in relapse rate [ Time Frame: upto 9 months ]
  2. to study the total cumulative dose of corticosteroids adminstered and adjuvants required among patients of the 2 treatment groups [ Time Frame: upto 9 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01974518


Locations
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India
PGIMER
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
Investigators
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Principal Investigator: Shraddha Uprety, MBBS Postgraduate Institute of Medical Education and Research
More Information
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Responsible Party: Uprety Shraddha, Junior Resident, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01974518    
Other Study ID Numbers: 9187-PG-2012
First Posted: November 1, 2013    Key Record Dates
Last Update Posted: October 30, 2014
Last Verified: October 2014
Keywords provided by Uprety Shraddha, Postgraduate Institute of Medical Education and Research:
Pemphigus
Rituximab
Rituximab and IV cyclophosphamide combination
B cell re-population characteristics following Rituximab
Additional relevant MeSH terms:
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Pemphigus
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Cyclophosphamide
Rituximab
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological