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NCT00422383 · OUTCOME

Percentage of Participants With Positive Human Anti-Chimeric Antibody (HACA) Titers

A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA) · Source last updated 2015-05-04

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
BL, Weeks 24 and 48

What was measured

A participant was defined as being HACA positive if the HACA serum level was ≥ 5 relative units (RU) per mL and the physician comment read that participant was "immunodepletable with rituximab".

Analysis population: SAP, n=number of participants assessed for the given parameter at the specified timepoint.

Groups in this outcome

Rituximab Low Dose + Methotrexate

Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.

Rituximab Escalated Dose + Methotrexate

Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.

Rituximab High Dose + Methotrexate

Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.

Rituximab/Placebo + Methotrexate

Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.

Rituximab Decreased Dose + Methotrexate

Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.

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 Low Dose + Methotrexate131
Rituximab Escalated Dose + Methotrexate115
Rituximab High Dose + Methotrexate91
Rituximab/Placebo + Methotrexate6
Rituximab Decreased Dose + Methotrexate25

Reported measurements

BL (n=131,115,91,6,25)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab Low Dose + Methotrexate0.0Not reportedNot reportedNot reportedNot reported
Rituximab Escalated Dose + Methotrexate0.9Not reportedNot reportedNot reportedNot reported
Rituximab High Dose + Methotrexate0.0Not reportedNot reportedNot reportedNot reported
Rituximab/Placebo + Methotrexate0.0Not reportedNot reportedNot reportedNot reported
Rituximab Decreased Dose + Methotrexate0.0Not reportedNot reportedNot reportedNot reported
Wk 24 (n=118,109,86,4,24)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab Low Dose + Methotrexate5.1Not reportedNot reportedNot reportedNot reported
Rituximab Escalated Dose + Methotrexate7.3Not reportedNot reportedNot reportedNot reported
Rituximab High Dose + Methotrexate2.3Not reportedNot reportedNot reportedNot reported
Rituximab/Placebo + Methotrexate0.0Not reportedNot reportedNot reportedNot reported
Rituximab Decreased Dose + Methotrexate0.0Not reportedNot reportedNot reportedNot reported
Wk 48 (n=115,104,87,4,22)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab Low Dose + Methotrexate4.3Not reportedNot reportedNot reportedNot reported
Rituximab Escalated Dose + Methotrexate1.0Not reportedNot reportedNot reportedNot reported
Rituximab High Dose + Methotrexate2.3Not reportedNot reportedNot reportedNot reported
Rituximab/Placebo + Methotrexate25.0Not reportedNot reportedNot reportedNot reported
Rituximab Decreased Dose + Methotrexate0.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
      2. group Id
        OG001
        value
        0.9
      3. group Id
        OG002
        value
        0.0
      4. group Id
        OG003
        value
        0.0
      5. group Id
        OG004
        value
        0.0
    title
    BL (n=131,115,91,6,25)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5.1
      2. group Id
        OG001
        value
        7.3
      3. group Id
        OG002
        value
        2.3
      4. group Id
        OG003
        value
        0.0
      5. group Id
        OG004
        value
        0.0
    title
    Wk 24 (n=118,109,86,4,24)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4.3
      2. group Id
        OG001
        value
        1.0
      3. group Id
        OG002
        value
        2.3
      4. group Id
        OG003
        value
        25.0
      5. group Id
        OG004
        value
        0.0
    title
    Wk 48 (n=115,104,87,4,22)
denoms
  1. counts
    1. group Id
      OG000
      value
      131
    2. group Id
      OG001
      value
      115
    3. group Id
      OG002
      value
      91
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      25
    units
    Participants
description
A participant was defined as being HACA positive if the HACA serum level was ≥ 5 relative units (RU) per mL and the physician comment read that participant was "immunodepletable with rituximab".
groups
  1. description
    Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
    id
    OG000
    title
    Rituximab Low Dose + Methotrexate
  2. description
    Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
    id
    OG001
    title
    Rituximab Escalated Dose + Methotrexate
  3. description
    Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
    id
    OG002
    title
    Rituximab High Dose + Methotrexate
  4. description
    Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
    id
    OG003
    title
    Rituximab/Placebo + Methotrexate
  5. description
    Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
    id
    OG004
    title
    Rituximab Decreased Dose + Methotrexate
param Type
NUMBER
population Description
SAP, n=number of participants assessed for the given parameter at the specified timepoint.
reporting Status
POSTED
time Frame
BL, Weeks 24 and 48
title
Percentage of Participants With Positive Human Anti-Chimeric Antibody (HACA) Titers
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice