TriangleNCT01469013 · OUTCOME
Percentage of Participants Who Achieved an European League Against Rheumatism Rating of 28-Joint Arthritic Condition (EULAR28) Response at 12 Weeks (Part A)
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
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 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 | Source count |
|---|---|
| 1 mg Baricitinib (LY3009104) | 24 |
| 2 mg Baricitinib (LY3009104) | 24 |
| 4 mg Baricitinib (LY3009104) | 24 |
| 8 mg Baricitinib (LY3009104) | 24 |
| Placebo | 49 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 1 mg Baricitinib (LY3009104) | 83 | Not reported | Not reported | Not reported | Not reported |
| 2 mg Baricitinib (LY3009104) | 88 | Not reported | Not reported | Not reported | Not reported |
| 4 mg Baricitinib (LY3009104) | 92 | Not reported | Not reported | Not reported | Not reported |
| 8 mg Baricitinib (LY3009104) | 92 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 47 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 83
- group Id
- OG001
- value
- 88
- group Id
- OG002
- value
- 92
- group Id
- OG003
- value
- 92
- group Id
- OG004
- value
- 47
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 24
- group Id
- OG003
- value
- 24
- group Id
- OG004
- value
- 49
- 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
- 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)
- 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)
- 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)
- 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)
- 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 European League Against Rheumatism Rating of 28-Joint Arthritic Condition (EULAR28) Response at 12 Weeks (Part A)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice