TriangleNCT01721044 · OUTCOME
Change From Baseline in the DAS28 - hsCRP - Placebo Versus Baricitinib 2 mg
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 12
What was measured
DAS28 consisted of composite score of following variables: TJC28, SJC28, hsCRP (mg/mL), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-CRP=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural log(CRP+1)+0.014\*Patient's Global VAS+0.96. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Analysis population: mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.
Groups in this outcome
Placebo
Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
Baricitinib 2 mg
Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
| Group | Source count |
|---|---|
| Placebo | 176 |
| Baricitinib 2 mg | 174 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | -0.85 | 1.19 | Not reported | Not reported | Not reported |
| Baricitinib 2 mg | -1.53 | 1.34 | Not reported | Not reported | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.001
- statistical Method
- ANCOVA
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.001
- statistical Method
- ANCOVA
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.19
- value
- -0.85
- group Id
- OG001
- spread
- 1.34
- value
- -1.53
- denoms
- counts
- group Id
- OG000
- value
- 176
- group Id
- OG001
- value
- 174
- units
- Participants
- description
- DAS28 consisted of composite score of following variables: TJC28, SJC28, hsCRP (mg/mL), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-CRP=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural log(CRP+1)+0.014\*Patient's Global VAS+0.96. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
- dispersion Type
- Standard Deviation
- groups
- description
- Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
- id
- OG000
- title
- Placebo
- description
- Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
- id
- OG001
- title
- Baricitinib 2 mg
- param Type
- MEAN
- population Description
- mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 12
- title
- Change From Baseline in the DAS28 - hsCRP - Placebo Versus Baricitinib 2 mg
- type
- SECONDARY
- unit Of Measure
- Units on a Scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice