TriangleNCT01469013 · OUTCOME
Mean Change From Baseline to Week 64 in 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, 64 weeks
What was measured
DAS modified included the 28 diarthroidal joint count (DAS28) that consisted of a composite score of the following variables: TJC28, SJC28, CRP (mg/L), and PtGADA on a 0 to 100 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 B and had DAS28-CRP evaluated at analysis time points. The last non-missing post-baseline value in Part B was used.
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 | Source count |
|---|---|
| Combined 4 mg Baricitinib (LY3009104) | 71 |
| Combined 8 mg Baricitinib (LY3009104) | 70 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combined 4 mg Baricitinib (LY3009104) | -2.44 | 1.152 | Not reported | Not reported | Not reported |
| Combined 8 mg Baricitinib (LY3009104) | -2.48 | 1.109 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.152
- value
- -2.44
- group Id
- OG001
- spread
- 1.109
- value
- -2.48
- denoms
- counts
- group Id
- OG000
- value
- 71
- group Id
- OG001
- value
- 70
- units
- Participants
- description
- DAS modified included the 28 diarthroidal joint count (DAS28) that consisted of a composite score of the following variables: TJC28, SJC28, CRP (mg/L), and PtGADA on a 0 to 100 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 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)
- 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
- MEAN
- population Description
- All randomized participants who received any study drug in Part B and had DAS28-CRP evaluated at analysis time points. The last non-missing post-baseline value in Part B was used.
- reporting Status
- POSTED
- time Frame
- Baseline, 64 weeks
- title
- Mean Change From Baseline to Week 64 in 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