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NCT00282308 · OUTCOME

Serum Level of Anti-pneumococcal Antibody Measured Immediately Prior to and 4 Weeks After Administration of a 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
GEOMETRIC_MEAN
Unit
µg/mL
Interval / dispersion
95% Confidence Interval
Time frame
Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group B

What was measured

Anti-pneumococcal antibody was measured immediately prior to and 4 weeks after administration of a 23-valent pneumococcal polysaccharide vaccine. 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.

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

Pre-vaccination
Values in µg/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Rituximab + Methotrexate (Group A)0.8Not reported0.641.06Not reported
Methotrexate (Group B)1.0Not reported0.681.47Not reported
4 weeks post-vaccination
Values in µg/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Rituximab + Methotrexate (Group A)1.0Not reported0.761.37Not reported
Methotrexate (Group B)2.3Not reported1.393.89Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.64
        upper Limit
        1.06
        value
        0.8
      2. group Id
        OG001
        lower Limit
        0.68
        upper Limit
        1.47
        value
        1.0
    title
    Pre-vaccination
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.76
        upper Limit
        1.37
        value
        1.0
      2. group Id
        OG001
        lower Limit
        1.39
        upper Limit
        3.89
        value
        2.3
    title
    4 weeks post-vaccination
denoms
  1. counts
    1. group Id
      OG000
      value
      63
    2. group Id
      OG001
      value
      28
    units
    Participants
description
Anti-pneumococcal antibody was measured immediately prior to and 4 weeks after administration of a 23-valent pneumococcal polysaccharide vaccine. 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.
dispersion Type
95% Confidence Interval
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
GEOMETRIC_MEAN
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
Serum Level of Anti-pneumococcal Antibody Measured Immediately Prior to and 4 Weeks After Administration of a 23-valent Pneumococcal Polysaccharide Vaccine
type
SECONDARY
unit Of Measure
µg/mL

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

Preserved source evidence · Not medical advice