TriangleNCT02552212 · OUTCOME
Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- scores on a scale
- Interval / dispersion
- Standard Error
- Time frame
- From Baseline to Week 12
What was measured
The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 (not active) to 10 (very active), with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Analysis population: The FAS consisted of all subjects in the RS who have received at least 1 dose of study medication.
Groups in this outcome
Placebo (FAS)
Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).
CZP 200 mg Q2W (FAS)
Certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards. Subjects formed the FAS.
| Group | Source count |
|---|---|
| Placebo (FAS) | 158 |
| CZP 200 mg Q2W (FAS) | 159 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo (FAS) | -0.91 | 0.22 | Not reported | Not reported | Not reported |
| CZP 200 mg Q2W (FAS) | -2.73 | 0.21 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -2.250
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -1.388
- group Description
- From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.001
- param Type
- Difference
- param Value
- -1.819
- statistical Method
- ANCOVA
Complete source fields
- analyses
- ci Lower Limit
- -2.250
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -1.388
- group Description
- From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.001
- param Type
- Difference
- param Value
- -1.819
- statistical Method
- ANCOVA
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.22
- value
- -0.91
- group Id
- OG001
- spread
- 0.21
- value
- -2.73
- denoms
- counts
- group Id
- OG000
- value
- 158
- group Id
- OG001
- value
- 159
- units
- Participants
- description
- The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 (not active) to 10 (very active), with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
- dispersion Type
- Standard Error
- groups
- description
- Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).
- id
- OG000
- title
- Placebo (FAS)
- description
- Certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards. Subjects formed the FAS.
- id
- OG001
- title
- CZP 200 mg Q2W (FAS)
- param Type
- LEAST_SQUARES_MEAN
- population Description
- The FAS consisted of all subjects in the RS who have received at least 1 dose of study medication.
- reporting Status
- POSTED
- time Frame
- From Baseline to Week 12
- title
- Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
- type
- SECONDARY
- unit Of Measure
- scores on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice