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NCT03112603 · OUTCOME

Percentage of Participants With a ≥ 50% Reduction in Daily Corticosteroid Dose

A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3) · Source last updated 2025-08-12

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
from Day 15 up to Day 182

What was measured

All corticosteroid dosages prescribed to the participant and all dose changes during the study were to be recorded for assessment of participants with a ≥ 50% reduction in daily corticosteroid dose.

Analysis population: Safety Set: all participants who received at least one dose of study treatment. Participants were to have been analyzed according to the study treatment received, where treatment received was defined as the randomized treatment if the participant took at least one dose of that treatment or the first treatment received if the randomized treatment was never received. Six participants in the BAT arm discontinued before receiving the first dose. Only participants with available data were analyzed.

Groups in this outcome

Ruxolitinib

Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).

Best Available Therapy

Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.

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

Analysis denominator · Participants

GroupSource count
Ruxolitinib165
Best Available Therapy158

Reported measurements

Day 15 to ≤ Day 28

Analysis denominator · Participants

GroupSource count
Ruxolitinib158
Best Available Therapy152
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib12.7Not reportedNot reportedNot reportedNot reported
Best Available Therapy13.2Not reportedNot reportedNot reportedNot reported
Day 29 to ≤ Day 42

Analysis denominator · Participants

GroupSource count
Ruxolitinib157
Best Available Therapy148
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib35.0Not reportedNot reportedNot reportedNot reported
Best Available Therapy33.1Not reportedNot reportedNot reportedNot reported
Day 43 to ≤ Day 56

Analysis denominator · Participants

GroupSource count
Ruxolitinib153
Best Available Therapy146
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib48.4Not reportedNot reportedNot reportedNot reported
Best Available Therapy41.1Not reportedNot reportedNot reportedNot reported
Day 57 to ≤ Day 70

Analysis denominator · Participants

GroupSource count
Ruxolitinib150
Best Available Therapy142
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib58.7Not reportedNot reportedNot reportedNot reported
Best Available Therapy47.9Not reportedNot reportedNot reportedNot reported
Day 71 to ≤ Day 84

Analysis denominator · Participants

GroupSource count
Ruxolitinib146
Best Available Therapy138
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib62.3Not reportedNot reportedNot reportedNot reported
Best Available Therapy51.4Not reportedNot reportedNot reportedNot reported
Day 85 to ≤ Day 98

Analysis denominator · Participants

GroupSource count
Ruxolitinib141
Best Available Therapy137
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib69.5Not reportedNot reportedNot reportedNot reported
Best Available Therapy54.0Not reportedNot reportedNot reportedNot reported
Day 99 to ≤ Day 112

Analysis denominator · Participants

GroupSource count
Ruxolitinib132
Best Available Therapy134
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib71.2Not reportedNot reportedNot reportedNot reported
Best Available Therapy60.4Not reportedNot reportedNot reportedNot reported
Day 113 to ≤ Day 126

Analysis denominator · Participants

GroupSource count
Ruxolitinib127
Best Available Therapy130
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib73.2Not reportedNot reportedNot reportedNot reported
Best Available Therapy66.2Not reportedNot reportedNot reportedNot reported
Day 127 to ≤ Day 140

Analysis denominator · Participants

GroupSource count
Ruxolitinib125
Best Available Therapy123
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib72.8Not reportedNot reportedNot reportedNot reported
Best Available Therapy68.3Not reportedNot reportedNot reportedNot reported
Day 141 to ≤ Day 154

Analysis denominator · Participants

GroupSource count
Ruxolitinib120
Best Available Therapy120
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib70.0Not reportedNot reportedNot reportedNot reported
Best Available Therapy68.3Not reportedNot reportedNot reportedNot reported
Day 155 to ≤ Day 168

Analysis denominator · Participants

GroupSource count
Ruxolitinib118
Best Available Therapy116
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib74.6Not reportedNot reportedNot reportedNot reported
Best Available Therapy71.6Not reportedNot reportedNot reportedNot reported
Day 169 to ≤ Day 182

Analysis denominator · Participants

GroupSource count
Ruxolitinib116
Best Available Therapy89
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib81.9Not reportedNot reportedNot reportedNot reported
Best Available Therapy88.8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        12.7
      2. group Id
        OG001
        value
        13.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        158
      2. group Id
        OG001
        value
        152
      units
      Participants
    title
    Day 15 to ≤ Day 28
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        35.0
      2. group Id
        OG001
        value
        33.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        157
      2. group Id
        OG001
        value
        148
      units
      Participants
    title
    Day 29 to ≤ Day 42
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        48.4
      2. group Id
        OG001
        value
        41.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        153
      2. group Id
        OG001
        value
        146
      units
      Participants
    title
    Day 43 to ≤ Day 56
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        58.7
      2. group Id
        OG001
        value
        47.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        150
      2. group Id
        OG001
        value
        142
      units
      Participants
    title
    Day 57 to ≤ Day 70
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        62.3
      2. group Id
        OG001
        value
        51.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        146
      2. group Id
        OG001
        value
        138
      units
      Participants
    title
    Day 71 to ≤ Day 84
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        69.5
      2. group Id
        OG001
        value
        54.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        141
      2. group Id
        OG001
        value
        137
      units
      Participants
    title
    Day 85 to ≤ Day 98
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        71.2
      2. group Id
        OG001
        value
        60.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        132
      2. group Id
        OG001
        value
        134
      units
      Participants
    title
    Day 99 to ≤ Day 112
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        73.2
      2. group Id
        OG001
        value
        66.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        127
      2. group Id
        OG001
        value
        130
      units
      Participants
    title
    Day 113 to ≤ Day 126
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        72.8
      2. group Id
        OG001
        value
        68.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        125
      2. group Id
        OG001
        value
        123
      units
      Participants
    title
    Day 127 to ≤ Day 140
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        70.0
      2. group Id
        OG001
        value
        68.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        120
      2. group Id
        OG001
        value
        120
      units
      Participants
    title
    Day 141 to ≤ Day 154
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        74.6
      2. group Id
        OG001
        value
        71.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        118
      2. group Id
        OG001
        value
        116
      units
      Participants
    title
    Day 155 to ≤ Day 168
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        81.9
      2. group Id
        OG001
        value
        88.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        116
      2. group Id
        OG001
        value
        89
      units
      Participants
    title
    Day 169 to ≤ Day 182
denoms
  1. counts
    1. group Id
      OG000
      value
      165
    2. group Id
      OG001
      value
      158
    units
    Participants
description
All corticosteroid dosages prescribed to the participant and all dose changes during the study were to be recorded for assessment of participants with a ≥ 50% reduction in daily corticosteroid dose.
groups
  1. description
    Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).
    id
    OG000
    title
    Ruxolitinib
  2. description
    Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.
    id
    OG001
    title
    Best Available Therapy
param Type
NUMBER
population Description
Safety Set: all participants who received at least one dose of study treatment. Participants were to have been analyzed according to the study treatment received, where treatment received was defined as the randomized treatment if the participant took at least one dose of that treatment or the first treatment received if the randomized treatment was never received. Six participants in the BAT arm discontinued before receiving the first dose. Only participants with available data were analyzed.
reporting Status
POSTED
time Frame
from Day 15 up to Day 182
title
Percentage of Participants With a ≥ 50% Reduction in Daily Corticosteroid Dose
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice