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NCT01469013 · OUTCOME

Percentage of Participants Who Achieved an SDAI Remission at 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
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Baseline up to 12 weeks

What was measured

The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, PtGADA, PhGA 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. Definition of remission is SDAI ≤ 3.3. Percentage of participants = (number of responders) / (number of participants treated) \* 100

Analysis population: All participants who received any amount of study drug in Part A.

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 percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1 mg Baricitinib (LY3009104)4Not reportedNot reportedNot reportedNot reported
2 mg Baricitinib (LY3009104)29Not reportedNot reportedNot reportedNot reported
4 mg Baricitinib (LY3009104)17Not reportedNot reportedNot reportedNot reported
8 mg Baricitinib (LY3009104)17Not reportedNot reportedNot reportedNot reported
Placebo8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        29
      3. group Id
        OG002
        value
        17
      4. group Id
        OG003
        value
        17
      5. group Id
        OG004
        value
        8
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, PtGADA, PhGA 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. Definition of remission is SDAI ≤ 3.3. Percentage of participants = (number of responders) / (number of participants treated) \* 100
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
NUMBER
population Description
All participants who received any amount of study drug in Part A.
reporting Status
POSTED
time Frame
Baseline up to 12 weeks
title
Percentage of Participants Who Achieved an SDAI Remission at 12 Weeks (Part A)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice