TriangleNCT01721044 · OUTCOME
Change From Baseline in Clinical Disease Activity Index 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 CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
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 mLOCF.
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.
Baricitinib 4 mg
Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
| Group | Source count |
|---|---|
| Placebo | 170 |
| Baricitinib 2 mg | 169 |
| Baricitinib 4 mg | 171 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | -12.19 | 16.96 | Not reported | Not reported | Not reported |
| Baricitinib 2 mg | -17.17 | 16.96 | Not reported | Not reported | Not reported |
| Baricitinib 4 mg | -20.30 | 16.29 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.001
- p Value Comment
- a priori p-value significance threshold: 2-sided ≤0.05
- statistical Method
- ANCOVA
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.009
- p Value Comment
- a priori p-value significance threshold: 2-sided ≤0.05
- statistical Method
- ANCOVA
Complete source fields
- analyses
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.001
- p Value Comment
- a priori p-value significance threshold: 2-sided ≤0.05
- statistical Method
- ANCOVA
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.009
- p Value Comment
- a priori p-value significance threshold: 2-sided ≤0.05
- statistical Method
- ANCOVA
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 16.96
- value
- -12.19
- group Id
- OG001
- spread
- 16.96
- value
- -17.17
- group Id
- OG002
- spread
- 16.29
- value
- -20.30
- denoms
- counts
- group Id
- OG000
- value
- 170
- group Id
- OG001
- value
- 169
- group Id
- OG002
- value
- 171
- units
- Participants
- description
- The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
- 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
- description
- Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
- id
- OG002
- title
- Baricitinib 4 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 mLOCF.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 24
- title
- Change From Baseline in Clinical Disease Activity Index Score
- type
- SECONDARY
- unit Of Measure
- Units on a Scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice