TriangleNCT04221477 · OUTCOME
Change in Systematic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Error
- Time frame
- At Week 76
What was measured
The SLEDAI-2K is a 24-item instrument that evaluates clinical symptoms and laboratory markers across nine organ systems and was used to capture changes in lupus-related disease activity. SLE manifestations are assessed by the clinician if present within the last 30 days and added to determine the total SLEDAI-2K score, which ranges from 0 to 105. Higher scores indicate increased disease activity. The analysis was performed using ANCOVA. Death was considered as an intercurrent event which was handled under composite strategy by imputing data after death with 105, the highest possible score. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Adjusted mean has been reported.
Analysis population: Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups.
Groups in this outcome
Obinutuzumab
Participants received obinutuzumab, 1000 mg as an IV infusion on Day 1 and Weeks 2, 24, 26, and either Weeks 50 and 52 or Week 52 only, along with MMF and SOC therapy. Placebo was administered at Week 50 for participants not treated with obinutuzumab. Participants with adequate response at Week 76 continued to receive obinutuzumab at Week 80 and Q6M thereafter. The dose of MMF can be adjusted at the investigator's discretion beginning at Week 80.
Placebo
Participants received Obinutuzumab matching placebo as an IV infusion on Day 1 and Weeks 2, 24, 26, 50, and 52. Participants also received SOC therapy and MMF. Participants with adequate response at Week 76 continued to receive placebo at Week 80 and Q6M thereafter.
| Group | Source count |
|---|---|
| Obinutuzumab | 135 |
| Placebo | 136 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Obinutuzumab | -5.63 | 1.456 | Not reported | Not reported | Not reported |
| Placebo | -5.51 | 1.432 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -3.11
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.87
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.9384
- p Value Comment
- Not type I error controlled.
- param Type
- Difference in Adjusted Means
- param Value
- -0.12
- statistical Method
- ANCOVA
Complete source fields
- analyses
- ci Lower Limit
- -3.11
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.87
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.9384
- p Value Comment
- Not type I error controlled.
- param Type
- Difference in Adjusted Means
- param Value
- -0.12
- statistical Method
- ANCOVA
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.456
- value
- -5.63
- group Id
- OG001
- spread
- 1.432
- value
- -5.51
- denoms
- counts
- group Id
- OG000
- value
- 135
- group Id
- OG001
- value
- 136
- units
- Participants
- description
- The SLEDAI-2K is a 24-item instrument that evaluates clinical symptoms and laboratory markers across nine organ systems and was used to capture changes in lupus-related disease activity. SLE manifestations are assessed by the clinician if present within the last 30 days and added to determine the total SLEDAI-2K score, which ranges from 0 to 105. Higher scores indicate increased disease activity. The analysis was performed using ANCOVA. Death was considered as an intercurrent event which was handled under composite strategy by imputing data after death with 105, the highest possible score. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Adjusted mean has been reported.
- dispersion Type
- Standard Error
- groups
- description
- Participants received obinutuzumab, 1000 mg as an IV infusion on Day 1 and Weeks 2, 24, 26, and either Weeks 50 and 52 or Week 52 only, along with MMF and SOC therapy. Placebo was administered at Week 50 for participants not treated with obinutuzumab. Participants with adequate response at Week 76 continued to receive obinutuzumab at Week 80 and Q6M thereafter. The dose of MMF can be adjusted at the investigator's discretion beginning at Week 80.
- id
- OG000
- title
- Obinutuzumab
- description
- Participants received Obinutuzumab matching placebo as an IV infusion on Day 1 and Weeks 2, 24, 26, 50, and 52. Participants also received SOC therapy and MMF. Participants with adequate response at Week 76 continued to receive placebo at Week 80 and Q6M thereafter.
- id
- OG001
- title
- Placebo
- param Type
- MEAN
- population Description
- Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups.
- reporting Status
- POSTED
- time Frame
- At Week 76
- title
- Change in Systematic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
- type
- SECONDARY
- unit Of Measure
- score on a scale
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Preserved source evidence · Not medical advice