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A CLINICAL TRIAL TO COMPARE THE EFFECT OF LOW DOSE WITH CONVENTIONAL DOSE OF RITUXIMAB USED IN PATIENTS OF SEVERE PEMPHIGUS

COMPARATIVE STUDY TO ASSESS THE EFFICACY AND COST EFFICIENCY OF IMMUNOLOGICALLY- TARGETED LOW DOSE RITUXIMAB PROTOCOL WITH THE CONVENTIONAL RHEUMATOID ARTHRITIS PROTOCOL IN SIGNIFICANT PEMPHIGUS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/10/015943
Enrollment
20
Registered
2018-10-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L100- Pemphigus vulgaris Health Condition 2: L100- Pemphigus vulgaris

Interventions

Intervention1: RITUXIMAB: Group A will receive conventional dose Rituximab (1000 mg, 2 doses, 2 weeks apart) according to rheumatoid arthritis protocol. Control Intervention1: RITUXIMAB: Group B will

Sponsors

DEPARTMENT OF DERMATOLOGY
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: PATIENTS OF PEMPHIGUS VULGARIS OR PEMPHIGUS FOLIACEOUS IN THE ABOVE MENTIONED AGE GROUP WITH SIGNIFICANT CLINICAL DISEASE WITH PDAI( PEMPHIGUS DISEASE ACTIVITY INDEX) SCORE >15 AND WHO ARE WILLING FOR MONTHLY FOLLOW UP VISITS FOR 12 MONTHS.

Exclusion criteria

Exclusion criteria: PATIENTS WITH ACTIVE OR LATENT INFECTIONS LIKE HEPATITIS, TB OR SEPSIS.PREGNANT AND LACTATING FEMALES, PATIENTS WITH KNOWN CARDIAC ABNORMALITIES OR ARRHYTHMIA, SEVERELY DECREASED BONE MARROW FUNCTIONS, KNOWN HYPERSENSITIVITY TO MURINE PROTEINS OR ORAL CORTICOSTEROIDS. PATIENTS WHO HAVE RECEIVED RITUXIMAB IN PRECEDING 12 MONTHS OR DEXAMETHASONE PULSE THERAPY IN PRECEDING 3 MONTHS WILL ALSO BE EXCLUDED.

Design outcomes

Primary

MeasureTime frame
COMPLETE REMISSION ON MINIMAL THERAPY AND COMPLETE REMISSION OFF THERAPY.Timepoint: COMPLETE REMISSION ON MINIMAL THERAPY AND COMPLETE REMISSION OFF THERAPY.

Secondary

MeasureTime frame
IMMUNOLOGICAL RE POPULATION OF B LYMPHOCYTES OR CLINICAL RELAPSE OF THE DISEASETimepoint: MONTHLY VISITS FOR 12 MONTHS

Countries

India

Contacts

Public ContactNAMRATA

PGIMER

handa_sanjeev@yahoo.com9815924777

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026