Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01469013 · OUTCOME

Percentage of Participants Who Achieved an EULAR28 Response at 64 Weeks (Part B)

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 64 weeks

What was measured

EULAR Responder Index based on 28 joint counts categorizes clinical response based on improvement from baseline in DAS28-CRP. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. High disease activity: DAS28-CRP \>5.1, low disease activity: DAS28-CRP \<3.2, and remission: DAS28-CRP \<2.6. Participants are categorized as EULAR responders or non-responders based on improvement of DAS28-CRP scores from baseline. EULAR DAS28-CRP Responder Index defines a good (absolute: ≤3.2 and \>1.2 improvement from baseline), moderate (absolute: \>3.2 and ≤5.1 and \>0.6 and ≤1.2 improvement from baseline), or no response (absolute: \>5.1 and ≤0.6 improvement from baseline). Percentage of participants calculated as = (number of good +moderate responders) / (number of participants treated) \* 100.

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

Groups in this outcome

Combined 4 mg Baricitinib (LY3009104)

Participants on background methotrexate therapy who were administered 1 mg, 2 mg, 4 mg baricitinib (LY3009104) capsule or identical placebo capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.

Combined 8 mg Baricitinib (LY3009104)

Participants on background methotrexate therapy who were administered 1 mg, 2 mg, 8 mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.

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

Analysis denominator · Participants

GroupSource count
Combined 4 mg Baricitinib (LY3009104)71
Combined 8 mg Baricitinib (LY3009104)70

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combined 4 mg Baricitinib (LY3009104)94Not reportedNot reportedNot reportedNot reported
Combined 8 mg Baricitinib (LY3009104)94Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        94
      2. group Id
        OG001
        value
        94
denoms
  1. counts
    1. group Id
      OG000
      value
      71
    2. group Id
      OG001
      value
      70
    units
    Participants
description
EULAR Responder Index based on 28 joint counts categorizes clinical response based on improvement from baseline in DAS28-CRP. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. High disease activity: DAS28-CRP \>5.1, low disease activity: DAS28-CRP \<3.2, and remission: DAS28-CRP \<2.6. Participants are categorized as EULAR responders or non-responders based on improvement of DAS28-CRP scores from baseline. EULAR DAS28-CRP Responder Index defines a good (absolute: ≤3.2 and \>1.2 improvement from baseline), moderate (absolute: \>3.2 and ≤5.1 and \>0.6 and ≤1.2 improvement from baseline), or no response (absolute: \>5.1 and ≤0.6 improvement from baseline). Percentage of participants calculated as = (number of good +moderate responders) / (number of participants treated) \* 100.
groups
  1. description
    Participants on background methotrexate therapy who were administered 1 mg, 2 mg, 4 mg baricitinib (LY3009104) capsule or identical placebo capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
    id
    OG000
    title
    Combined 4 mg Baricitinib (LY3009104)
  2. description
    Participants on background methotrexate therapy who were administered 1 mg, 2 mg, 8 mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
    id
    OG001
    title
    Combined 8 mg Baricitinib (LY3009104)
param Type
NUMBER
population Description
All participants who received any amount of study drug in Part B.
reporting Status
POSTED
time Frame
Baseline up to 64 weeks
title
Percentage of Participants Who Achieved an EULAR28 Response at 64 Weeks (Part B)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice