TriangleNCT02186873 · OUTCOME
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Units on Scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline and Week 16
What was measured
BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: tragus to wall distance, lumbar flexion, cervical rotation, lumbar side flexion, and intermalleolar distance. Each measure was scored 0-2 (0=normal mobility/mild disease involvement, 1=moderate disease involvement, 2=severe disease involvement) to give a final total BASMI score ranging from 0 to 10. The higher the BASMI score, the more severe was the participant's limitation of movement due to their AS.
Analysis population: FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Groups in this outcome
Group 1: Placebo Then Golimumab
Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
Group 2: Golimumab
Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
| Group | Source count |
|---|---|
| Group 1: Placebo Then Golimumab | 96 |
| Group 2: Golimumab | 100 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 1: Placebo Then Golimumab | -0.15 | 0.737 | Not reported | Not reported | Not reported |
| Group 2: Golimumab | -0.73 | 0.910 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.737
- value
- -0.15
- group Id
- OG001
- spread
- 0.910
- value
- -0.73
- denoms
- counts
- group Id
- OG000
- value
- 96
- group Id
- OG001
- value
- 100
- units
- Participants
- description
- BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: tragus to wall distance, lumbar flexion, cervical rotation, lumbar side flexion, and intermalleolar distance. Each measure was scored 0-2 (0=normal mobility/mild disease involvement, 1=moderate disease involvement, 2=severe disease involvement) to give a final total BASMI score ranging from 0 to 10. The higher the BASMI score, the more severe was the participant's limitation of movement due to their AS.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
- id
- OG000
- title
- Group 1: Placebo Then Golimumab
- description
- Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
- id
- OG001
- title
- Group 2: Golimumab
- param Type
- MEAN
- population Description
- FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Baseline and Week 16
- title
- Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16
- type
- SECONDARY
- unit Of Measure
- Units on Scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice