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

Uprety Shraddha

Status and phase: Unknown; Phase 3

Conditions: Pemphigus

Treatments: Drug: Rituximab and Cyclophosphamide IV

Study type: Interventional

Funder types: Other

Identifiers

NCT01974518

9187-PG-2012

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Rituximab

Active Comparator group

Description:

Inj Rituximab 1 gram IV given on day 0 and day 15

Treatment:

Drug: Rituximab and Cyclophosphamide IV

Combination of Rituximab and Cyclophosphamide IV

Active Comparator group

Description:

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

Treatment:

Drug: Rituximab and Cyclophosphamide IV