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NCT05059262 · OUTCOME

Change From Baseline in Active Range of Motion (ROM) at Week 25

Study of Vimseltinib for Tenosynovial Giant Cell Tumor · Source last updated 2026-03-20

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

Measure
LEAST_SQUARES_MEAN
Unit
Change in percent
Interval / dispersion
Standard Error
Time frame
Baseline to Week 25 (Cycle 7, Day 1)

What was measured

Presented here is the change from baseline in active ROM to Week 25. Measurement of the affected and contralateral, non-affected joint was assessed by goniometer and measured in degrees. At baseline, the motion with the smallest relative ROM value (worst) was identified, and this motion was used for evaluating the change in relative ROM subsequently. The affected joint measurement was used to derive a relative ROM based on active measurement relative to reference standard value provided by the American Medical Association. Relative ROM is expressed in percent: 100 x (joint ROM measure)/(reference ROM standard).

Analysis population: The ITT Set consisted of participants who were randomized to a study treatment regimen. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure at the specified time point.

Groups in this outcome

Vimseltinib

Participants received 30 mg BIW vimseltinib for 24 weeks.

Placebo

Participants received matching placebo BIW for 24 weeks.

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

Analysis denominator · Participants

GroupSource count
Vimseltinib73
Placebo33

Reported measurements

Source class 1
Values in Change in percent · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Vimseltinib18.46.46Not reportedNot reportedNot reported
Placebo3.87.19Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    4.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    25.3
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0077
    p Value Comment
    Model included treatment+visit+treatment by visit interaction+stratification factor for region (U.S. versus non-U.S.)+joint type (knee, ankle, or other)+the most impaired ROM baseline value.
    param Type
    LS Mean Difference
    param Value
    14.6
    statistical Method
    Mixed model repeated measures
Complete source fields
analyses
  1. ci Lower Limit
    4.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    25.3
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0077
    p Value Comment
    Model included treatment+visit+treatment by visit interaction+stratification factor for region (U.S. versus non-U.S.)+joint type (knee, ankle, or other)+the most impaired ROM baseline value.
    param Type
    LS Mean Difference
    param Value
    14.6
    statistical Method
    Mixed model repeated measures
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.46
        value
        18.4
      2. group Id
        OG001
        spread
        7.19
        value
        3.8
denoms
  1. counts
    1. group Id
      OG000
      value
      73
    2. group Id
      OG001
      value
      33
    units
    Participants
description
Presented here is the change from baseline in active ROM to Week 25. Measurement of the affected and contralateral, non-affected joint was assessed by goniometer and measured in degrees. At baseline, the motion with the smallest relative ROM value (worst) was identified, and this motion was used for evaluating the change in relative ROM subsequently. The affected joint measurement was used to derive a relative ROM based on active measurement relative to reference standard value provided by the American Medical Association. Relative ROM is expressed in percent: 100 x (joint ROM measure)/(reference ROM standard).
dispersion Type
Standard Error
groups
  1. description
    Participants received 30 mg BIW vimseltinib for 24 weeks.
    id
    OG000
    title
    Vimseltinib
  2. description
    Participants received matching placebo BIW for 24 weeks.
    id
    OG001
    title
    Placebo
param Type
LEAST_SQUARES_MEAN
population Description
The ITT Set consisted of participants who were randomized to a study treatment regimen. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure at the specified time point.
reporting Status
POSTED
time Frame
Baseline to Week 25 (Cycle 7, Day 1)
title
Change From Baseline in Active Range of Motion (ROM) at Week 25
type
SECONDARY
unit Of Measure
Change in percent

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

Preserved source evidence · Not medical advice