TriangleNCT03112603 · OUTCOME
Efficacy of Ruxolitinib Versus Investigator's Choice Best Available Therapy (BAT) in Participants With Moderate or Severe Steroid Refractory Chronic Graft Versus Host Disease (SR-cGvHD) Assessed by Overall Response Rate (ORR) at the Cycle 7 Day 1 Visit
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
- Cycle 7 Day 1 (each cycle was comprised of 4 weeks)
What was measured
ORR was defined as the percentage of participants in each arm demonstrating a complete response (CR) or partial response (PR) based on chronic GvHD (cGvHD) disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response. Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies.
Analysis population: Full Analysis Set (FAS): all participants to whom study treatment was assigned by randomization. Data reported are from the start of the study to Cycle 7 Day 1 (data cutoff of 08 May 2020).
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 | 164 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ruxolitinib | 49.7 | Not reported | 41.8 | 57.6 | Not reported |
| Best Available Therapy | 25.6 | Not reported | 19.1 | 33.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.86
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.80
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.0001
- param Type
- Odds Ratio (OR)
- param Value
- 2.99
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 1.86
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.80
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.0001
- param Type
- Odds Ratio (OR)
- param Value
- 2.99
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 41.8
- upper Limit
- 57.6
- value
- 49.7
- group Id
- OG001
- lower Limit
- 19.1
- upper Limit
- 33.0
- value
- 25.6
- denoms
- counts
- group Id
- OG000
- value
- 165
- group Id
- OG001
- value
- 164
- units
- Participants
- description
- ORR was defined as the percentage of participants in each arm demonstrating a complete response (CR) or partial response (PR) based on chronic GvHD (cGvHD) disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response. Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies.
- dispersion Type
- 95% Confidence Interval
- 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
- Full Analysis Set (FAS): all participants to whom study treatment was assigned by randomization. Data reported are from the start of the study to Cycle 7 Day 1 (data cutoff of 08 May 2020).
- reporting Status
- POSTED
- time Frame
- Cycle 7 Day 1 (each cycle was comprised of 4 weeks)
- title
- Efficacy of Ruxolitinib Versus Investigator's Choice Best Available Therapy (BAT) in Participants With Moderate or Severe Steroid Refractory Chronic Graft Versus Host Disease (SR-cGvHD) Assessed by Overall Response Rate (ORR) at the Cycle 7 Day 1 Visit
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice