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

NCT01974518 | Unknown Phase 3

• 1 other identifier: 9187-PG-2012
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Pemphigus

Keywords

Pemphigus; Rituximab; Rituximab and IV cyclophosphamide combination; B cell re-population characteristics following Rituximab

Outcome Measures

Primary Outcomes (1)

• 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

  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

  upto 9 months

Secondary Outcomes (1)

• Study the characteristics of B cell depletion and repopulation following IV rituximab and combination of IV cyclophosphamide with IV rituximab.

  upto 9 months

Other Outcomes (2)

• To study the difference in relapse rate

  upto 9 months

• to study the total cumulative dose of corticosteroids adminstered and adjuvants required among patients of the 2 treatment groups

  upto 9 months

Study Arms (2)

Rituximab

ACTIVE COMPARATOR

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

Drug: Rituximab and Cyclophosphamide IV

Combination of Rituximab and Cyclophosphamide IV

ACTIVE COMPARATOR

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

Interventions

Rituximab and Cyclophosphamide IV DRUG

Combination of Rituximab and Cyclophosphamide IV; Rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uprety Shraddha: lead
• Post Graduate Institute of Medical Education and Research, Chandigarh: collaborator

Study Sites (2)

PGIMER

Chandigarh, Chandigarh, 160012, India

Location

Post-graduate Institute of Medical Education and Research

Chandigarh, Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Pemphigus

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Shraddha Uprety, MBBS

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: UNKNOWN
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Junior Resident

Study Record Dates

• First Submitted: October 4, 2013
• First Posted: November 1, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 30, 2014

Record last verified: 2014-10

Locations

IN (2)