TriangleNCT00889863 · OUTCOME
Part I: Percentage of Patients on Steroids at Study Start Who Reached a Steroid Dose ≤0.2 mg/kg at End of Part Ic
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 28 Weeks
Analysis population: Participants from the Full Analysis set who were taking oral steroids at the start of the study.
Groups in this outcome
Canakinumab
In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a \>0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
| Group | Source count |
|---|---|
| Canakinumab | 128 |
Reported measurements
steroid free
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab | 32.8 | Not reported | 24.8 | 41.7 | Not reported |
>0 and ≤ 0.2 mg/kg/day
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab | 18.8 | Not reported | 12.4 | 26.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 24.8
- upper Limit
- 41.7
- value
- 32.8
- title
- steroid free
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.4
- upper Limit
- 26.6
- value
- 18.8
- title
- >0 and ≤ 0.2 mg/kg/day
- denoms
- counts
- group Id
- OG000
- value
- 128
- units
- Participants
- dispersion Type
- 95% Confidence Interval
- groups
- description
- In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a \>0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
- id
- OG000
- title
- Canakinumab
- param Type
- NUMBER
- population Description
- Participants from the Full Analysis set who were taking oral steroids at the start of the study.
- reporting Status
- POSTED
- time Frame
- 28 Weeks
- title
- Part I: Percentage of Patients on Steroids at Study Start Who Reached a Steroid Dose ≤0.2 mg/kg at End of Part Ic
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice