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NCT02093026 · OUTCOME

Percentage of Participants Who Discontinued Treatment Due to Insufficient Response

Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA) · Source last updated 2017-03-13

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
First, second, third, fourth, fifth, sixth, and seventh course of rituximab (up to a median of approximately 2, 62, 124, 186, 248, 310, and 372 weeks, respectively)

Analysis population: Safety Population. Number analyzed = participants who were evaluable for specified category.

Groups in this outcome

Rituximab

Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid \>=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.

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

Analysis denominator · Participants

GroupSource count
Rituximab465

Reported measurements

First course

Analysis denominator · Participants

GroupSource count
Rituximab465
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab1.1Not reportedNot reportedNot reportedNot reported
Second course

Analysis denominator · Participants

GroupSource count
Rituximab427
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab2.3Not reportedNot reportedNot reportedNot reported
Third course

Analysis denominator · Participants

GroupSource count
Rituximab350
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab2.0Not reportedNot reportedNot reportedNot reported
Fourth course

Analysis denominator · Participants

GroupSource count
Rituximab296
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab2.0Not reportedNot reportedNot reportedNot reported
Fifth course

Analysis denominator · Participants

GroupSource count
Rituximab243
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab0.8Not reportedNot reportedNot reportedNot reported
Sixth course

Analysis denominator · Participants

GroupSource count
Rituximab198
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab0.0Not reportedNot reportedNot reportedNot reported
Seventh course

Analysis denominator · Participants

GroupSource count
Rituximab156
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab0.6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        465
      units
      Participants
    title
    First course
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        427
      units
      Participants
    title
    Second course
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        350
      units
      Participants
    title
    Third course
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        296
      units
      Participants
    title
    Fourth course
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        243
      units
      Participants
    title
    Fifth course
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        198
      units
      Participants
    title
    Sixth course
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        156
      units
      Participants
    title
    Seventh course
denoms
  1. counts
    1. group Id
      OG000
      value
      465
    units
    Participants
groups
  1. description
    Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid \>=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
    id
    OG000
    title
    Rituximab
param Type
NUMBER
population Description
Safety Population. Number analyzed = participants who were evaluable for specified category.
reporting Status
POSTED
time Frame
First, second, third, fourth, fifth, sixth, and seventh course of rituximab (up to a median of approximately 2, 62, 124, 186, 248, 310, and 372 weeks, respectively)
title
Percentage of Participants Who Discontinued Treatment Due to Insufficient Response
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice