TriangleNCT01721057 · OUTCOME
Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) ≤3.3
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
- Week 12
What was measured
SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Participant's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.
Analysis population: mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.
Groups in this outcome
Placebo
Placebo administered orally (PO) once daily (QD) through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
Baricitinib 2 mg
Baricitinib 2 mg PO QD through week 24. Participants will continued to take background cDMARD therapy throughout study.
Baricitinib 4 mg
Baricitinib 4 mg PO QD through week 24. Participants continued to take background cDMARD therapy throughout study.
| Group | Source count |
|---|---|
| Placebo | 228 |
| Baricitinib 2 mg | 229 |
| Baricitinib 4 mg | 227 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 0.9 | Not reported | Not reported | Not reported | Not reported |
| Baricitinib 2 mg | 9.2 | Not reported | Not reported | Not reported | Not reported |
| Baricitinib 4 mg | 8.8 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.9
- group Id
- OG001
- value
- 9.2
- group Id
- OG002
- value
- 8.8
- denoms
- counts
- group Id
- OG000
- value
- 228
- group Id
- OG001
- value
- 229
- group Id
- OG002
- value
- 227
- units
- Participants
- description
- SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Participant's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.
- groups
- description
- Placebo administered orally (PO) once daily (QD) through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
- id
- OG000
- title
- Placebo
- description
- Baricitinib 2 mg PO QD through week 24. Participants will continued to take background cDMARD therapy throughout study.
- id
- OG001
- title
- Baricitinib 2 mg
- description
- Baricitinib 4 mg PO QD through week 24. Participants continued to take background cDMARD therapy throughout study.
- id
- OG002
- title
- Baricitinib 4 mg
- param Type
- NUMBER
- population Description
- mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.
- reporting Status
- POSTED
- time Frame
- Week 12
- title
- Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) ≤3.3
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice