TriangleNCT01469013 · OUTCOME
Percentage of Participants Who Achieved an SDAI 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
The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, PtGADA, PhGA, and CRP. The equation used to calculate the SDAI: SDAI=SJC28+TJC28+PtGADA-VAS+PhGA-VAS+CRP where PtGADA-VAS=PtGADA-VAS / 10 and PhGA-VAS=PhGA-VAS / 10. Definition of remission is SDAI ≤ 3.3. Percentage of participants = (number of responders) / (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) | 39 | Not reported | Not reported | Not reported | Not reported |
| Combined 8 mg Baricitinib (LY3009104) | 39 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 39
- group Id
- OG001
- value
- 39
- denoms
- counts
- group Id
- OG000
- value
- 71
- group Id
- OG001
- value
- 70
- units
- Participants
- description
- The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, PtGADA, PhGA, and CRP. The equation used to calculate the SDAI: SDAI=SJC28+TJC28+PtGADA-VAS+PhGA-VAS+CRP where PtGADA-VAS=PtGADA-VAS / 10 and PhGA-VAS=PhGA-VAS / 10. Definition of remission is SDAI ≤ 3.3. Percentage of participants = (number of responders) / (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 an SDAI 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