NCT01721057 · OUTCOME
Percentage of Participants Achieving American College of Rheumatology European League Against Rheumatism (ACR/EULAR) Remission - Boolean Remission
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 12
What was measured
The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.
Analysis population: mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.
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 | 228 |
| Baricitinib 2 mg | 229 |
| Baricitinib 4 mg | 227 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 0.4 | Not reported | Not reported | Not reported | Not reported |
| Baricitinib 2 mg | 7.0 | Not reported | Not reported | Not reported | Not reported |
| Baricitinib 4 mg | 6.6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.4
- group Id
- OG001
- value
- 7.0
- group Id
- OG002
- value
- 6.6
- denoms
- counts
- group Id
- OG000
- value
- 228
- group Id
- OG001
- value
- 229
- group Id
- OG002
- value
- 227
- units
- Participants
- description
- The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.
- 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
- NUMBER
- population Description
- mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.
- reporting Status
- POSTED
- time Frame
- Week 12
- title
- Percentage of Participants Achieving American College of Rheumatology European League Against Rheumatism (ACR/EULAR) Remission - Boolean Remission
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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