TriangleNCT01721057 · OUTCOME
Change From Baseline in Measures of Simplified Disease Activity Index (SDAI) Score
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, Week 24
What was measured
The 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), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). A negative change from baseline indicates an improvement.
Analysis population: mITT population: all randomized participants who received at least 1 dose of the study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.
Groups in this outcome
Placebo
Placebo administered orally once daily through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
Baricitinib 2 mg
Baricitinib 2 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.
Baricitinib 4 mg
Baricitinib 4 mg administered orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study.
| Group | Source count |
|---|---|
| Placebo | 218 |
| Baricitinib 2 mg | 224 |
| Baricitinib 4 mg | 219 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | -14.55 | 16.37 | Not reported | Not reported | Not reported |
| Baricitinib 2 mg | -21.87 | 14.99 | Not reported | Not reported | Not reported |
| Baricitinib 4 mg | -23.78 | 13.94 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 16.37
- value
- -14.55
- group Id
- OG001
- spread
- 14.99
- value
- -21.87
- group Id
- OG002
- spread
- 13.94
- value
- -23.78
- denoms
- counts
- group Id
- OG000
- value
- 218
- group Id
- OG001
- value
- 224
- group Id
- OG002
- value
- 219
- units
- Participants
- description
- The 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), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). A negative change from baseline indicates an improvement.
- dispersion Type
- Standard Deviation
- groups
- description
- Placebo administered orally once daily 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 administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.
- id
- OG001
- title
- Baricitinib 2 mg
- description
- Baricitinib 4 mg administered orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study.
- id
- OG002
- title
- Baricitinib 4 mg
- param Type
- MEAN
- population Description
- mITT population: all randomized participants who received at least 1 dose of the study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 24
- title
- Change From Baseline in Measures of Simplified Disease Activity Index (SDAI) Score
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice