TriangleNCT01721057 · OUTCOME
Change From Baseline in Measures of Clinical Disease Activity Index (CDAI) 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: 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 modified last observation carried forward (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 continued 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 | -14.29 | 16.04 | Not reported | Not reported | Not reported |
| Baricitinib 2 mg | -20.99 | 14.48 | Not reported | Not reported | Not reported |
| Baricitinib 4 mg | -23.18 | 13.47 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 16.04
- value
- -14.29
- group Id
- OG001
- spread
- 14.48
- value
- -20.99
- group Id
- OG002
- spread
- 13.47
- value
- -23.18
- denoms
- counts
- group Id
- OG000
- value
- 218
- group Id
- OG001
- value
- 224
- group Id
- OG002
- value
- 219
- 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 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 continued 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 modified last observation carried forward (mLOCF) .
- reporting Status
- POSTED
- time Frame
- Baseline, Week 24
- title
- Change From Baseline in Measures of Clinical Disease Activity Index (CDAI) Score
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice