TriangleNCT02277444 · OUTCOME
Baysesian Area Under Curve at Steady State (AUCss) at Week 52
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- mcg*day/mL
- Interval / dispersion
- Full Range
- Time frame
- Week 52
What was measured
AUCss was defined as area under the plasma concentration-time curve at steady-state (based on steady-state assessment of trough concentrations or via modeling).
Analysis population: The PK analysis set included all treated participants (who received at least 1 infusion) who have sufficient PK samples for analysis.
Groups in this outcome
Golimumab
Participants received 80 milligrams per meter square (mg/m\^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and then every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m\^2 per week for participants with BSA less than \[\<\] 1.67 meter square \[m\^2\], or minimum of 15 mg/week for participants with BSA greater than or equal to \[\>=\] 1.67 m\^2) as at time of study entry. After Week 28, changes in MTX administration were permitted. Participants who completed Week 52 had the option to enter into the long-term extension (LTE) phase. Participants who opted not to enter the LTE completed an additional 8-week safety follow-up visit following the last administration of the study agent. Participants who entered LTE continued to receive 80 mg/m\^2 IV golimumab q8w through Week 244. All participants who completed Week 244 were followed for safety through Week 252. Participants who met the inclusion criteria entered the extended treatment period (ETP) and continued to receive 80 mg/m\^2 IV golimumab q8w from Week 252 to Week 420.
| Group | Source count |
|---|---|
| Golimumab | 127 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Golimumab | 421 | Not reported | 402 | 446 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 402
- upper Limit
- 446
- value
- 421
- denoms
- counts
- group Id
- OG000
- value
- 127
- units
- Participants
- description
- AUCss was defined as area under the plasma concentration-time curve at steady-state (based on steady-state assessment of trough concentrations or via modeling).
- dispersion Type
- Full Range
- groups
- description
- Participants received 80 milligrams per meter square (mg/m\^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and then every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m\^2 per week for participants with BSA less than \[\<\] 1.67 meter square \[m\^2\], or minimum of 15 mg/week for participants with BSA greater than or equal to \[\>=\] 1.67 m\^2) as at time of study entry. After Week 28, changes in MTX administration were permitted. Participants who completed Week 52 had the option to enter into the long-term extension (LTE) phase. Participants who opted not to enter the LTE completed an additional 8-week safety follow-up visit following the last administration of the study agent. Participants who entered LTE continued to receive 80 mg/m\^2 IV golimumab q8w through Week 244. All participants who completed Week 244 were followed for safety through Week 252. Participants who met the inclusion criteria entered the extended treatment period (ETP) and continued to receive 80 mg/m\^2 IV golimumab q8w from Week 252 to Week 420.
- id
- OG000
- title
- Golimumab
- param Type
- MEDIAN
- population Description
- The PK analysis set included all treated participants (who received at least 1 infusion) who have sufficient PK samples for analysis.
- reporting Status
- POSTED
- time Frame
- Week 52
- title
- Baysesian Area Under Curve at Steady State (AUCss) at Week 52
- type
- SECONDARY
- unit Of Measure
- mcg*day/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice