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NCT01469013 · OUTCOME

Mean Change in Simplified Disease Activity Index (SDAI) Responses up to 12 Weeks (Part A)

Oral Baricitinib (LY3009104)Treatment in Japanese Participants With Active Rheumatoid Arthritis on Background Methotrexate Therapy · Source last updated 2019-09-20

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

Measure
MEAN
Unit
units on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline up to 12 weeks

What was measured

The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, patient and physician global assessment of disease activity and CRP. The equation used to calculate the SDAI:SDAI=SJC28+TJC28+PtGADA-VAS+PhGA-VAS+CRP where PtGADA-VAS=PtGADA-VAS / 10 and PhGA-VAS=PhGA-VAS / 10, with lower values indicating fewer symptoms.

Analysis population: All participants who received any amount of study drug in Part A and had SDAI data at analysis time points. The last non-missing post-baseline value in Part A was used.

Groups in this outcome

1 mg Baricitinib (LY3009104)

Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.

2 mg Baricitinib (LY3009104)

Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.

4 mg Baricitinib (LY3009104)

Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.

8 mg Baricitinib (LY3009104)

Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.

Placebo

Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 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
1 mg Baricitinib (LY3009104)24
2 mg Baricitinib (LY3009104)24
4 mg Baricitinib (LY3009104)24
8 mg Baricitinib (LY3009104)24
Placebo49

Reported measurements

Source class 1
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1 mg Baricitinib (LY3009104)-13.118.918Not reportedNot reportedNot reported
2 mg Baricitinib (LY3009104)-16.859.517Not reportedNot reportedNot reported
4 mg Baricitinib (LY3009104)-18.179.202Not reportedNot reportedNot reported
8 mg Baricitinib (LY3009104)-18.028.293Not reportedNot reportedNot reported
Placebo-4.5413.113Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.918
        value
        -13.11
      2. group Id
        OG001
        spread
        9.517
        value
        -16.85
      3. group Id
        OG002
        spread
        9.202
        value
        -18.17
      4. group Id
        OG003
        spread
        8.293
        value
        -18.02
      5. group Id
        OG004
        spread
        13.113
        value
        -4.54
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    2. group Id
      OG001
      value
      24
    3. group Id
      OG002
      value
      24
    4. group Id
      OG003
      value
      24
    5. group Id
      OG004
      value
      49
    units
    Participants
description
The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, patient and physician global assessment of disease activity and CRP. The equation used to calculate the SDAI:SDAI=SJC28+TJC28+PtGADA-VAS+PhGA-VAS+CRP where PtGADA-VAS=PtGADA-VAS / 10 and PhGA-VAS=PhGA-VAS / 10, with lower values indicating fewer symptoms.
dispersion Type
Standard Deviation
groups
  1. description
    Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
    id
    OG000
    title
    1 mg Baricitinib (LY3009104)
  2. description
    Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
    id
    OG001
    title
    2 mg Baricitinib (LY3009104)
  3. description
    Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
    id
    OG002
    title
    4 mg Baricitinib (LY3009104)
  4. description
    Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
    id
    OG003
    title
    8 mg Baricitinib (LY3009104)
  5. description
    Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
    id
    OG004
    title
    Placebo
param Type
MEAN
population Description
All participants who received any amount of study drug in Part A and had SDAI data at analysis time points. The last non-missing post-baseline value in Part A was used.
reporting Status
POSTED
time Frame
Baseline up to 12 weeks
title
Mean Change in Simplified Disease Activity Index (SDAI) Responses up to 12 Weeks (Part A)
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice