Comparative Study of Rituximab Versus Combination of Rituximab and Intravenous Cyclophosphamide in Severe Pemphigus
NCT ID: NCT01974518
Last Updated: 2014-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
20 participants
INTERVENTIONAL
2013-11-30
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Rituximab
Inj Rituximab 1 gram IV given on day 0 and day 15
Rituximab and Cyclophosphamide IV
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
Rituximab and Cyclophosphamide IV
Interventions
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Rituximab and Cyclophosphamide IV
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Post Graduate Institute of Medical Education and Research, Chandigarh
OTHER
Uprety Shraddha
UNKNOWN
Responsible Party
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Uprety Shraddha
Junior Resident
Principal Investigators
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Shraddha Uprety, MBBS
Role: PRINCIPAL_INVESTIGATOR
Post Graduate Institute of Medical Education and Research, Chandigarh
Locations
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PGIMER
Chandigarh, Chandigarh, India
Post-graduate Institute of Medical Education and Research
Chandigarh, Chandigarh, India
Countries
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Other Identifiers
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9187-PG-2012
Identifier Type: -
Identifier Source: org_study_id
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