NCT03112603 · OUTCOME
Percentage of Participants Successfully Tapered Off of All Corticosteroids
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
- Not reported
- Time frame
- up to Day 179
What was measured
All corticosteroid dosages prescribed to the participant and all dose changes during the study were to be recorded for assessment of participants who successfully tapered off of all corticosteroids. Participants who completely tapered off corticosteroids refer to those who permanently discontinued steroids as per the dose administration panel and who did not restart steroids in the same interval. Participants who were tapered off and continued follow-up were also counted as being tapered off with 0 dose in subsequent intervals until they discontinued from the main treatment period or restarted steroid treatment.
Analysis population: FAS. Only participants with available data were analyzed.
Groups in this outcome
Ruxolitinib
Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).
Best Available Therapy
Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.
| Group | Source count |
|---|---|
| Ruxolitinib | 165 |
| Best Available Therapy | 158 |
Reported measurements
Day 1 to ≤ Day 28
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ruxolitinib | 2.5 | Not reported | Not reported | Not reported | Not reported |
| Best Available Therapy | 2.6 | Not reported | Not reported | Not reported | Not reported |
Day 29 to ≤ Day 56
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ruxolitinib | 9.6 | Not reported | Not reported | Not reported | Not reported |
| Best Available Therapy | 5.4 | Not reported | Not reported | Not reported | Not reported |
Day 57 to ≤ Day 84
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ruxolitinib | 14.0 | Not reported | Not reported | Not reported | Not reported |
| Best Available Therapy | 8.5 | Not reported | Not reported | Not reported | Not reported |
Day 85 to ≤ Day 112
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ruxolitinib | 16.3 | Not reported | Not reported | Not reported | Not reported |
| Best Available Therapy | 10.3 | Not reported | Not reported | Not reported | Not reported |
Day 113 to ≤ Day 140
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ruxolitinib | 19.7 | Not reported | Not reported | Not reported | Not reported |
| Best Available Therapy | 12.4 | Not reported | Not reported | Not reported | Not reported |
Day 141 to ≤ Day 168
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ruxolitinib | 24.2 | Not reported | Not reported | Not reported | Not reported |
| Best Available Therapy | 16.8 | Not reported | Not reported | Not reported | Not reported |
Day 169 to ≤ Day 179
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ruxolitinib | 24.1 | Not reported | Not reported | Not reported | Not reported |
| Best Available Therapy | 15.9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2.5
- group Id
- OG001
- value
- 2.6
- title
- Day 1 to ≤ Day 28
- categories
- measurements
- group Id
- OG000
- value
- 9.6
- group Id
- OG001
- value
- 5.4
- title
- Day 29 to ≤ Day 56
- categories
- measurements
- group Id
- OG000
- value
- 14.0
- group Id
- OG001
- value
- 8.5
- title
- Day 57 to ≤ Day 84
- categories
- measurements
- group Id
- OG000
- value
- 16.3
- group Id
- OG001
- value
- 10.3
- title
- Day 85 to ≤ Day 112
- categories
- measurements
- group Id
- OG000
- value
- 19.7
- group Id
- OG001
- value
- 12.4
- title
- Day 113 to ≤ Day 140
- categories
- measurements
- group Id
- OG000
- value
- 24.2
- group Id
- OG001
- value
- 16.8
- title
- Day 141 to ≤ Day 168
- categories
- measurements
- group Id
- OG000
- value
- 24.1
- group Id
- OG001
- value
- 15.9
- title
- Day 169 to ≤ Day 179
- denoms
- counts
- group Id
- OG000
- value
- 165
- group Id
- OG001
- value
- 158
- units
- Participants
- description
- All corticosteroid dosages prescribed to the participant and all dose changes during the study were to be recorded for assessment of participants who successfully tapered off of all corticosteroids. Participants who completely tapered off corticosteroids refer to those who permanently discontinued steroids as per the dose administration panel and who did not restart steroids in the same interval. Participants who were tapered off and continued follow-up were also counted as being tapered off with 0 dose in subsequent intervals until they discontinued from the main treatment period or restarted steroid treatment.
- groups
- description
- Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).
- id
- OG000
- title
- Ruxolitinib
- description
- Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.
- id
- OG001
- title
- Best Available Therapy
- param Type
- NUMBER
- population Description
- FAS. Only participants with available data were analyzed.
- reporting Status
- POSTED
- time Frame
- up to Day 179
- title
- Percentage of Participants Successfully Tapered Off of All Corticosteroids
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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