TriangleNCT01721044 · OUTCOME
Percentage of Participants Achieving ACR20 Response
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 24
What was measured
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.
Analysis population: Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug. Participants will be 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 NRI.
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 | 176 |
| Baricitinib 2 mg | 174 |
| Baricitinib 4 mg | 177 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 27.3 | Not reported | Not reported | Not reported | Not reported |
| Baricitinib 2 mg | 44.8 | Not reported | Not reported | Not reported | Not reported |
| Baricitinib 4 mg | 46.3 | Not reported | 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 Comment
- If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
- statistical Method
- Regression, Logistic
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG001
- 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 Comment
- If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
- statistical Method
- Regression, Logistic
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 Comment
- If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
- statistical Method
- Regression, Logistic
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG001
- 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 Comment
- If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
- statistical Method
- Regression, Logistic
- classes
- categories
- measurements
- group Id
- OG000
- value
- 27.3
- group Id
- OG001
- value
- 44.8
- group Id
- OG002
- value
- 46.3
- denoms
- counts
- group Id
- OG000
- value
- 176
- group Id
- OG001
- value
- 174
- group Id
- OG002
- value
- 177
- units
- Participants
- description
- ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.
- 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
- NUMBER
- population Description
- Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug. Participants will be 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 NRI.
- reporting Status
- POSTED
- time Frame
- Week 24
- title
- Percentage of Participants Achieving ACR20 Response
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice