Clinical trial NCT01974518: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pemphigus
Keywords: Pemphigus
Rituximab
Rituximab and IV cyclophosphamide combination
B cell re-population characteristics following Rituximab
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
Collaborators: name: Post Graduate Institute of Medical Education and Research, Chandigarh
First posted: 2013-11-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
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
timeFrame: upto 9 months
Secondary outcomes:
measure: Study the characteristics of B cell depletion and repopulation following IV rituximab and combination of IV cyclophosphamide with IV rituximab.
timeFrame: upto 9 months
Other outcomes:
measure: To study the difference in relapse rate
timeFrame: upto 9 months
measure: to study the total cumulative dose of corticosteroids adminstered and adjuvants required among patients of the 2 treatment groups
timeFrame: upto 9 months
Locations:
city: Chandigarh
country: India
facility: PGIMER
city: Chandigarh
country: India
facility: Post-graduate Institute of Medical Education and Research
Study officials:
affiliation: PGIMER
name: Shraddha Uprety, MBBS
role: PRINCIPAL_INVESTIGATOR
References: