TriangleNCT02181673 · OUTCOME
Change From Baseline in Leeds Enthesitis Index (LEI) at Week 14 in Participants With Enthesitis at Baseline
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
Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
Analysis population: Population included all randomized participants with Enthesitis at Baseline. 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 | 173 |
| Golimumab | 182 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | -0.8 | 1.98 | Not reported | Not reported | Not reported |
| Golimumab | -1.8 | 1.75 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.98
- value
- -0.8
- group Id
- OG001
- spread
- 1.75
- value
- -1.8
- denoms
- counts
- group Id
- OG000
- value
- 173
- group Id
- OG001
- value
- 182
- units
- Participants
- description
- Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
- 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
- Population included all randomized participants with Enthesitis at Baseline. 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 Leeds Enthesitis Index (LEI) at Week 14 in Participants With Enthesitis at Baseline
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice