TriangleNCT01469013 · OUTCOME
Mean Change From Baseline to Week 12 in Disease Activity Score (DAS) Based on the 28 Diarthrodial Joint Count and CRP Level (DAS28-CRP)
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, 12 weeks
What was measured
DAS modified included the DAS28 that consisted of a composite score of the following variables: tender joint count out of 28 (TJC28), swollen joint count out of 28 (SJC28), CRP \[milligrams per liter (mg/L)\], and PtGADA on a 0 to 100 millimeter (mm) VAS (0mm=no arthritis activity to 100 mm= extremely active arthritis). DAS28 calculated as: DAS28-CRP = 0.56(square root of TJC28)+0.28(square root of SJC28)+0.36\[ln(CRP +1)\]+0.014(VAS)+0.96. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Analysis population: All randomized participants who received any study drug in Part A and had DAS28-CRP evaluated 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 | 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) | -1.52 | 0.970 | Not reported | Not reported | Not reported |
| 2 mg Baricitinib (LY3009104) | -2.02 | 1.072 | Not reported | Not reported | Not reported |
| 4 mg Baricitinib (LY3009104) | -2.09 | 1.105 | Not reported | Not reported | Not reported |
| 8 mg Baricitinib (LY3009104) | -1.96 | 0.947 | Not reported | Not reported | Not reported |
| Placebo | -0.60 | 1.204 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.970
- value
- -1.52
- group Id
- OG001
- spread
- 1.072
- value
- -2.02
- group Id
- OG002
- spread
- 1.105
- value
- -2.09
- group Id
- OG003
- spread
- 0.947
- value
- -1.96
- group Id
- OG004
- spread
- 1.204
- value
- -0.60
- 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
- DAS modified included the DAS28 that consisted of a composite score of the following variables: tender joint count out of 28 (TJC28), swollen joint count out of 28 (SJC28), CRP \[milligrams per liter (mg/L)\], and PtGADA on a 0 to 100 millimeter (mm) VAS (0mm=no arthritis activity to 100 mm= extremely active arthritis). DAS28 calculated as: DAS28-CRP = 0.56(square root of TJC28)+0.28(square root of SJC28)+0.36\[ln(CRP +1)\]+0.014(VAS)+0.96. A decrease in DAS28-CRP indicated an improvement in participant's condition.
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- All randomized participants who received any study drug in Part A and had DAS28-CRP evaluated at analysis time points. The last non-missing post-baseline value in Part A was used.
- reporting Status
- POSTED
- time Frame
- Baseline, 12 weeks
- title
- Mean Change From Baseline to Week 12 in Disease Activity Score (DAS) Based on the 28 Diarthrodial Joint Count and CRP Level (DAS28-CRP)
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice