TriangleNCT02552212 · OUTCOME
Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 52
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of subjects
- Interval / dispersion
- Not reported
- Time frame
- Week 52
What was measured
The ASAS40 response was defined as relative improvements of at least 40% and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS), where 0 is "not active" and 10 is "very active" in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain.
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) | 15.8 | Not reported | Not reported | Not reported | Not reported |
| CZP 200 mg Q2W (FAS) | 56.6 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 4.286
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 12.636
- group Description
- Odds ratio: CZP/Placebo and p-value were calculated using logistic regression with factors for treatment, region MRI/CRP classification.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.001
- param Type
- Odds Ratio (OR)
- param Value
- 7.359
- statistical Method
- Regression, Logistic
Complete source fields
- analyses
- ci Lower Limit
- 4.286
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 12.636
- group Description
- Odds ratio: CZP/Placebo and p-value were calculated using logistic regression with factors for treatment, region MRI/CRP classification.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.001
- param Type
- Odds Ratio (OR)
- param Value
- 7.359
- statistical Method
- Regression, Logistic
- classes
- categories
- measurements
- group Id
- OG000
- value
- 15.8
- group Id
- OG001
- value
- 56.6
- denoms
- counts
- group Id
- OG000
- value
- 158
- group Id
- OG001
- value
- 159
- units
- Participants
- description
- The ASAS40 response was defined as relative improvements of at least 40% and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS), where 0 is "not active" and 10 is "very active" in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain.
- 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
- NUMBER
- 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
- Week 52
- title
- Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 52
- type
- SECONDARY
- unit Of Measure
- percentage of subjects
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice