TriangleNCT01469013 · OUTCOME
Percentage of Participants Who Achieved an ACR70 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
ACR70 responders were participants with at least 70% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, or PhGA-VAS. Missing values were imputed using NRI, where non-responders were participants who discontinued the study prior to the completion of Part A. Percentage of participants achieving ACR70 response=(number of ACR70 responders / number of participants treated) \* 100.
Analysis population: All participants who received any 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) | 13 | Not reported | Not reported | Not reported | Not reported |
| 2 mg Baricitinib (LY3009104) | 29 | Not reported | Not reported | Not reported | Not reported |
| 4 mg Baricitinib (LY3009104) | 29 | Not reported | Not reported | Not reported | Not reported |
| 8 mg Baricitinib (LY3009104) | 21 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG001
- OG002
- OG003
- OG004
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.009
- statistical Method
- Cochran-Armitage trend test
Complete source fields
- analyses
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG001
- OG002
- OG003
- OG004
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.009
- statistical Method
- Cochran-Armitage trend test
- classes
- categories
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 29
- group Id
- OG002
- value
- 29
- group Id
- OG003
- value
- 21
- group Id
- OG004
- value
- 0
- 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
- ACR70 responders were participants with at least 70% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, or PhGA-VAS. Missing values were imputed using NRI, where non-responders were participants who discontinued the study prior to the completion of Part A. Percentage of participants achieving ACR70 response=(number of ACR70 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 study drug in Part A.
- reporting Status
- POSTED
- time Frame
- Baseline up to 12 weeks
- title
- Percentage of Participants Who Achieved an ACR70 Response at 12 Weeks (Part A)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice