TriangleNCT01721044 · OUTCOME
Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- nanomoles/Liter (nmol/L)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose.
Analysis population: All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data. Participants who initially received 2 mg with renal impairment were randomized to 4mg (N=11). Participants starting on 4mg (N=177) and participants rescued to 4mg (N=33) are included in the PK baricitinib 4 mg arm.
Groups in this outcome
Baricitinib 2 mg
Baricitinib 2 mg administered PO QD through Week 24 (N=185). Participants who were randomized to 4mg (N=11) but actually received 2 mg due to moderate renal impairment were included in the 2-mg group. Participants continued to take background cDMARD therapy throughout study.
Baricitinib 4 mg
Baricitinib 4 mg administered PO QD through Week 24 (n=177). Participants rescued to 4mg (N=33) are included in the PK baricitinib 4 mg arm. Participants continued to take background cDMARD therapy throughout study.
| Group | Source count |
|---|---|
| Baricitinib 2 mg | 185 |
| Baricitinib 4 mg | 210 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Baricitinib 2 mg | 65.6 | 21.4 | Not reported | Not reported | Not reported |
| Baricitinib 4 mg | 130 | 19.3 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 21.4
- value
- 65.6
- group Id
- OG001
- spread
- 19.3
- value
- 130
- denoms
- counts
- group Id
- OG000
- value
- 185
- group Id
- OG001
- value
- 210
- units
- Participants
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Baricitinib 2 mg administered PO QD through Week 24 (N=185). Participants who were randomized to 4mg (N=11) but actually received 2 mg due to moderate renal impairment were included in the 2-mg group. Participants continued to take background cDMARD therapy throughout study.
- id
- OG000
- title
- Baricitinib 2 mg
- description
- Baricitinib 4 mg administered PO QD through Week 24 (n=177). Participants rescued to 4mg (N=33) are included in the PK baricitinib 4 mg arm. Participants continued to take background cDMARD therapy throughout study.
- id
- OG001
- title
- Baricitinib 4 mg
- param Type
- GEOMETRIC_MEAN
- population Description
- All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data. Participants who initially received 2 mg with renal impairment were randomized to 4mg (N=11). Participants starting on 4mg (N=177) and participants rescued to 4mg (N=33) are included in the PK baricitinib 4 mg arm.
- reporting Status
- POSTED
- time Frame
- Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose.
- title
- Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib
- type
- SECONDARY
- unit Of Measure
- nanomoles/Liter (nmol/L)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice