NCT01469013 · OUTCOME
Percentage of Participants Who Achieved a DAS28 Remission at 64 Weeks (Part B)
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
DAS modified included the DAS28 that consisted of a composite score of the following variables: TJC28, SJC28, CRP (mg/L), and PtGADA-VAS on a 0 to 100 mm VAS: 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). DAS28 calculated as: DAS28-CRP = 0.56(sqrt of TJC28)+0.28(sqrt of SJC28)+0.36\[ln(CRP +1)\]+0.014(VAS)+0.96. For remission, DAS28 is \<2.6. Percentage of participants = (number of participants with DAS 28 remission) / (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 | 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) | 66 | Not reported | Not reported | Not reported | Not reported |
| Combined 8 mg Baricitinib (LY3009104) | 66 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 66
- group Id
- OG001
- value
- 66
- denoms
- counts
- group Id
- OG000
- value
- 71
- group Id
- OG001
- value
- 70
- units
- Participants
- description
- DAS modified included the DAS28 that consisted of a composite score of the following variables: TJC28, SJC28, CRP (mg/L), and PtGADA-VAS on a 0 to 100 mm VAS: 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). DAS28 calculated as: DAS28-CRP = 0.56(sqrt of TJC28)+0.28(sqrt of SJC28)+0.36\[ln(CRP +1)\]+0.014(VAS)+0.96. For remission, DAS28 is \<2.6. Percentage of participants = (number of participants with DAS 28 remission) / (number of participants treated) \* 100.
- 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
- 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 a DAS28 Remission 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
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