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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Postgraduate Institute of Medical Education and Research
Sponsor:
Collaborator:
Postgraduate Institute of Medical Education and Research
Information provided by (Responsible Party):
Uprety Shraddha, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01974518
First received: October 4, 2013
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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
Pemphigus
Drug: Rituximab and Cyclophosphamide IV
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • to study the total cumulative dose of corticosteroids adminstered and adjuvants required among patients of the 2 treatment groups [ Time Frame: upto 9 months ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01974518

Contacts
Contact: Sunil Dogra, MBBS/MD/DNB 91-9855005941 sundogra@hotmail.com
Contact: Sanjeev Handa, MBBS/MD

Locations
India
Post-graduate Institute of Medical Education and Research Not yet recruiting
Chandigarh, India, 160012
Contact: Sunil Dogra, MBBS/MD/DNB    91-9855005941    sundogra@hotmail.com   
Principal Investigator: Shraddha Uprety, MBBS         
PGIMER Recruiting
Chandigarh, India, 160012
Contact: Shraddha Uprety, MBBS    8727045588    maitreeye@gmail.com.com   
Contact: h         
Sub-Investigator: Haridaran Anand Shanmugham, MBBS         
Sponsors and Collaborators
Uprety Shraddha
Postgraduate Institute of Medical Education and Research
Investigators
Principal Investigator: Shraddha Uprety, MBBS PGIMER
  More Information

No publications provided

Responsible Party: Uprety Shraddha, Junior Resident, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01974518     History of Changes
Other Study ID Numbers: 9187-PG-2012
Study First Received: October 4, 2013
Last Updated: November 21, 2013
Health Authority: India: Indian Council of Medical Research

Keywords provided by 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:
Pemphigus
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Cyclophosphamide
Rituximab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on July 22, 2014