TriangleNCT02181673 · OUTCOME
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 14
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline and Week 14
What was measured
The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Analysis population: The full analysis set (FAS) included all participants who were randomized. Here "N" (number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure.
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 | 222 |
| Golimumab | 233 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | -0.12 | 0.466 | Not reported | Not reported | Not reported |
| Golimumab | -0.60 | 0.530 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.466
- value
- -0.12
- group Id
- OG001
- spread
- 0.530
- value
- -0.60
- denoms
- counts
- group Id
- OG000
- value
- 222
- group Id
- OG001
- value
- 233
- units
- Participants
- description
- The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- The full analysis set (FAS) included all participants who were randomized. Here "N" (number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Baseline and Week 14
- title
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 14
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice