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NCT02383589 · OUTCOME

Percentage of Participants With Anti-Drug Antibodies (ADA)

A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV) · Source last updated 2020-11-10

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
Not reported
Time frame
Baseline up to 52 Weeks (up to CCOD of 28 November 2018)

What was measured

Participants with treatment-induced and treatment-enhanced anti-drug antibodies. The clinical relevance of anti-rituximab antibody formation in RITUXAN treated pemphigus vulgaris (PV) participants is unclear.

Analysis population: The safety population (all participants who were randomized and received any part of an infusion of study drug), only participants for whom data were collected are included in the analysis.

Groups in this outcome

Rituximab (RTX)

Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Rituximab (RTX)67

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab (RTX)31.7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        31.7
denoms
  1. counts
    1. group Id
      OG000
      value
      67
    units
    Participants
description
Participants with treatment-induced and treatment-enhanced anti-drug antibodies. The clinical relevance of anti-rituximab antibody formation in RITUXAN treated pemphigus vulgaris (PV) participants is unclear.
groups
  1. description
    Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.
    id
    OG000
    title
    Rituximab (RTX)
param Type
NUMBER
population Description
The safety population (all participants who were randomized and received any part of an infusion of study drug), only participants for whom data were collected are included in the analysis.
reporting Status
POSTED
time Frame
Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
title
Percentage of Participants With Anti-Drug Antibodies (ADA)
type
SECONDARY
unit Of Measure
Percentage of Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice