TriangleNCT02181673 · OUTCOME
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24
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
The ACR 50 response is defined as greater than or equal to (\>=) 50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and \>=50% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 centimeter \[cm\] scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).
Analysis population: The full analysis set (FAS) included all participants who were randomized.
Groups in this outcome
Placebo
Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
Golimumab
Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
| Group | Source count |
|---|---|
| Placebo | 239 |
| Golimumab | 241 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 6.3 | Not reported | Not reported | Not reported | Not reported |
| Golimumab | 53.5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6.3
- group Id
- OG001
- value
- 53.5
- denoms
- counts
- group Id
- OG000
- value
- 239
- group Id
- OG001
- value
- 241
- units
- Participants
- description
- The ACR 50 response is defined as greater than or equal to (\>=) 50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and \>=50% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 centimeter \[cm\] scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).
- groups
- description
- Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
- id
- OG000
- title
- Placebo
- description
- Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants received a placebo infusion to maintain the blind.
- id
- OG001
- title
- Golimumab
- param Type
- NUMBER
- population Description
- The full analysis set (FAS) included all participants who were randomized.
- reporting Status
- POSTED
- time Frame
- Week 24
- title
- Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice