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NCT00282308 · OUTCOME

Percentage of Patients With a Positive Immune Response to Each of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine

A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate · Source last updated 2017-08-10

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

Measure
NUMBER
Unit
Percentage of patients
Interval / dispersion
Not reported
Time frame
Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group B

What was measured

The immune response to each of the 12 anti-pneumococcal antibody serotypes was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The pneumococcal antibody assay was a fluoroimmunoassay that used a Luminex Multiplex platform. Purified capsular polysaccharides isolated from 12 serotypes of S. pneumonia were covalently attached to microbeads and used as a capturing reagent. Phycoerythrin conjugated anti-human IgG was used for detection. A positive immune response against a serotype was defined as a 2-fold increase or an increase of \> 1 μg/mL from pre-vaccination levels.

Analysis population: Immune response per-protocol population: Group A - All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B - All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.

Groups in this outcome

Rituximab + Methotrexate (Group A)

Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.

Methotrexate (Group B)

Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.

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 + Methotrexate (Group A)63
Methotrexate (Group B)28

Reported measurements

Serotype 1-146 (1)
Values in Percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab + Methotrexate (Group A)12.7Not reportedNot reportedNot reportedNot reported
Methotrexate (Group B)42.9Not reportedNot reportedNot reportedNot reported
Serotype 3-146 (3)
Values in Percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab + Methotrexate (Group A)9.5Not reportedNot reportedNot reportedNot reported
Methotrexate (Group B)28.6Not reportedNot reportedNot reportedNot reported
Serotype 4-146 (4)
Values in Percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab + Methotrexate (Group A)12.7Not reportedNot reportedNot reportedNot reported
Methotrexate (Group B)60.7Not reportedNot reportedNot reportedNot reported
Serotype 6/26-146 (6B)
Values in Percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab + Methotrexate (Group A)38.1Not reportedNot reportedNot reportedNot reported
Methotrexate (Group B)60.7Not reportedNot reportedNot reportedNot reported
Serotype 8-146 (8)
Values in Percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab + Methotrexate (Group A)33.3Not reportedNot reportedNot reportedNot reported
Methotrexate (Group B)57.1Not reportedNot reportedNot reportedNot reported
Serotype 9-146 (9N)
Values in Percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab + Methotrexate (Group A)22.2Not reportedNot reportedNot reportedNot reported
Methotrexate (Group B)60.7Not reportedNot reportedNot reportedNot reported
Serotype 12-146 (12F)
Values in Percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab + Methotrexate (Group A)11.1Not reportedNot reportedNot reportedNot reported
Methotrexate (Group B)50.0Not reportedNot reportedNot reportedNot reported
Serotype 14-146 (14)
Values in Percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab + Methotrexate (Group A)30.2Not reportedNot reportedNot reportedNot reported
Methotrexate (Group B)60.7Not reportedNot reportedNot reportedNot reported
Serotype 19-146 (19F)
Values in Percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab + Methotrexate (Group A)25.4Not reportedNot reportedNot reportedNot reported
Methotrexate (Group B)53.6Not reportedNot reportedNot reportedNot reported
Serotype 23-146 (23F)
Values in Percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab + Methotrexate (Group A)20.6Not reportedNot reportedNot reportedNot reported
Methotrexate (Group B)35.7Not reportedNot reportedNot reportedNot reported
Serotype 51-146 (7F)
Values in Percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab + Methotrexate (Group A)25.4Not reportedNot reportedNot reportedNot reported
Methotrexate (Group B)60.7Not reportedNot reportedNot reportedNot reported
Serotype 56-146 (18C)
Values in Percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab + Methotrexate (Group A)20.6Not reportedNot reportedNot reportedNot reported
Methotrexate (Group B)57.1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        12.7
      2. group Id
        OG001
        value
        42.9
    title
    Serotype 1-146 (1)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        9.5
      2. group Id
        OG001
        value
        28.6
    title
    Serotype 3-146 (3)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        12.7
      2. group Id
        OG001
        value
        60.7
    title
    Serotype 4-146 (4)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        38.1
      2. group Id
        OG001
        value
        60.7
    title
    Serotype 6/26-146 (6B)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        33.3
      2. group Id
        OG001
        value
        57.1
    title
    Serotype 8-146 (8)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        22.2
      2. group Id
        OG001
        value
        60.7
    title
    Serotype 9-146 (9N)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        11.1
      2. group Id
        OG001
        value
        50.0
    title
    Serotype 12-146 (12F)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        30.2
      2. group Id
        OG001
        value
        60.7
    title
    Serotype 14-146 (14)
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        25.4
      2. group Id
        OG001
        value
        53.6
    title
    Serotype 19-146 (19F)
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        20.6
      2. group Id
        OG001
        value
        35.7
    title
    Serotype 23-146 (23F)
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        25.4
      2. group Id
        OG001
        value
        60.7
    title
    Serotype 51-146 (7F)
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        20.6
      2. group Id
        OG001
        value
        57.1
    title
    Serotype 56-146 (18C)
denoms
  1. counts
    1. group Id
      OG000
      value
      63
    2. group Id
      OG001
      value
      28
    units
    Participants
description
The immune response to each of the 12 anti-pneumococcal antibody serotypes was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The pneumococcal antibody assay was a fluoroimmunoassay that used a Luminex Multiplex platform. Purified capsular polysaccharides isolated from 12 serotypes of S. pneumonia were covalently attached to microbeads and used as a capturing reagent. Phycoerythrin conjugated anti-human IgG was used for detection. A positive immune response against a serotype was defined as a 2-fold increase or an increase of \> 1 μg/mL from pre-vaccination levels.
groups
  1. description
    Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
    id
    OG000
    title
    Rituximab + Methotrexate (Group A)
  2. description
    Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
    id
    OG001
    title
    Methotrexate (Group B)
param Type
NUMBER
population Description
Immune response per-protocol population: Group A - All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B - All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.
reporting Status
POSTED
time Frame
Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group B
title
Percentage of Patients With a Positive Immune Response to Each of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine
type
SECONDARY
unit Of Measure
Percentage of patients

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Preserved source evidence · Not medical advice