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NCT00282308 · OUTCOME

Serum Level of Anti-tetanus Antibody Measured Immediately Prior to and 4 Weeks After Administration of a Tetanus Toxoid Adsorbed Booster 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
IU/mL
Interval / dispersion
95% Confidence Interval
Time frame
Week 24 to Week 28 for Group A and Day 1 to Week 4 for Group B

What was measured

Anti-tetanus antibody was measured in serum samples immediately prior to and 4 weeks after administration of a tetanus toxoid adsorbed booster vaccine. The tetanus antibody test was an ELISA that used tetanus toxoid as a capturing reagent and alkaline phosphatase-conjugated anti-human IgG (γ) 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)64
Methotrexate (Group B)26

Reported measurements

Pre-vaccination
Values in IU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Rituximab + Methotrexate (Group A)1.2Not reported0.881.69Not reported
Methotrexate (Group B)1.0Not reported0.492.14Not reported
4 weeks post-vaccination
Values in IU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Rituximab + Methotrexate (Group A)4.0Not reported2.725.74Not reported
Methotrexate (Group B)5.2Not reported2.2512.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.88
        upper Limit
        1.69
        value
        1.2
      2. group Id
        OG001
        lower Limit
        0.49
        upper Limit
        2.14
        value
        1.0
    title
    Pre-vaccination
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.72
        upper Limit
        5.74
        value
        4.0
      2. group Id
        OG001
        lower Limit
        2.25
        upper Limit
        12.00
        value
        5.2
    title
    4 weeks post-vaccination
denoms
  1. counts
    1. group Id
      OG000
      value
      64
    2. group Id
      OG001
      value
      26
    units
    Participants
description
Anti-tetanus antibody was measured in serum samples immediately prior to and 4 weeks after administration of a tetanus toxoid adsorbed booster vaccine. The tetanus antibody test was an ELISA that used tetanus toxoid as a capturing reagent and alkaline phosphatase-conjugated anti-human IgG (γ) 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 24 to Week 28 for Group A and Day 1 to Week 4 for Group B
title
Serum Level of Anti-tetanus Antibody Measured Immediately Prior to and 4 Weeks After Administration of a Tetanus Toxoid Adsorbed Booster Vaccine
type
SECONDARY
unit Of Measure
IU/mL

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

Preserved source evidence · Not medical advice