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

October 4, 2013
November 21, 2013
November 2013
June 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01974518 on ClinicalTrials.gov Archive Site
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.
Same as current
  • 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 ]
Same as current
 
Comparative Study of Rituximab Versus Combination of Rituximab and Intravenous Cyclophosphamide in Severe Pemphigus
A PILOT STUDY TO ASSESS THE EFFICACY OF RITUXIMAB VERSUS COMBINATION OF RITUXIMAB AND INTRAVENOUS CYCLOPHOSPHAMIDE IN THE TREATMENT OF REFRACTORY PEMPHIGUS

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Pemphigus
Drug: Rituximab and Cyclophosphamide IV
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
June 2015
June 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Sunil Dogra, MBBS/MD/DNB 91-9855005941 sundogra@hotmail.com
Contact: Sanjeev Handa, MBBS/MD
India
 
NCT01974518
9187-PG-2012
No
Uprety Shraddha, Postgraduate Institute of Medical Education and Research
Uprety Shraddha
Postgraduate Institute of Medical Education and Research
Principal Investigator: Shraddha Uprety, MBBS PGIMER
Postgraduate Institute of Medical Education and Research
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP