NCT02550652 · OUTCOME
Change From Baseline of Participant's Global Assessment of Disease Activity Visual Analog Scale (VAS) Score
A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN) · Source last updated 2024-08-27
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline (Day 1), Weeks 4, 12, 24, 36, 52
What was measured
Each VAS had a range from 0-100 with higher scores indicating greater symptom impact on global health status.
Analysis population: Modified intent-to-treat population will include all randomized participants who have received any amount of study drug. Participants who received an incorrect therapy were reported under the treatment arm to which they were randomized.
Groups in this outcome
OBINUTUZUMAB 1000MG and MMF
Participants received obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose was up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, could use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants could receive 1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants received 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
PLACEBO and MMF
Participants received placebo matching to obinutuzumab IV infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose was up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, could use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants could receive 1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants received 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| OBINUTUZUMAB 1000MG and MMF | 63 |
|---|
| PLACEBO and MMF | 62 |
|---|
Reported measurements
Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| OBINUTUZUMAB 1000MG and MMF | 58 |
|---|
| PLACEBO and MMF | 60 |
|---|
Values in score on scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| OBINUTUZUMAB 1000MG and MMF | 41.3 | 25.59 | Not reported | Not reported | Not reported |
|---|
| PLACEBO and MMF | 39.4 | 24.76 | Not reported | Not reported | Not reported |
|---|
Week 4
Analysis denominator · Participants
| Group | Source count |
|---|
| OBINUTUZUMAB 1000MG and MMF | 55 |
|---|
| PLACEBO and MMF | 57 |
|---|
Values in score on scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| OBINUTUZUMAB 1000MG and MMF | -14.4 | 18.28 | Not reported | Not reported | Not reported |
|---|
| PLACEBO and MMF | -8.7 | 22.69 | Not reported | Not reported | Not reported |
|---|
Week 12
Analysis denominator · Participants
| Group | Source count |
|---|
| OBINUTUZUMAB 1000MG and MMF | 57 |
|---|
| PLACEBO and MMF | 60 |
|---|
Values in score on scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| OBINUTUZUMAB 1000MG and MMF | -19.9 | 25.07 | Not reported | Not reported | Not reported |
|---|
| PLACEBO and MMF | -11.6 | 25.22 | Not reported | Not reported | Not reported |
|---|
Week 24
Analysis denominator · Participants
| Group | Source count |
|---|
| OBINUTUZUMAB 1000MG and MMF | 54 |
|---|
| PLACEBO and MMF | 56 |
|---|
Values in score on scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| OBINUTUZUMAB 1000MG and MMF | -25.0 | 25.17 | Not reported | Not reported | Not reported |
|---|
| PLACEBO and MMF | -20.8 | 24.74 | Not reported | Not reported | Not reported |
|---|
Week 36
Analysis denominator · Participants
| Group | Source count |
|---|
| OBINUTUZUMAB 1000MG and MMF | 54 |
|---|
| PLACEBO and MMF | 57 |
|---|
Values in score on scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| OBINUTUZUMAB 1000MG and MMF | -24.8 | 25.71 | Not reported | Not reported | Not reported |
|---|
| PLACEBO and MMF | -19.6 | 25.04 | Not reported | Not reported | Not reported |
|---|
Week 52
Analysis denominator · Participants
| Group | Source count |
|---|
| OBINUTUZUMAB 1000MG and MMF | 54 |
|---|
| PLACEBO and MMF | 56 |
|---|
Values in score on scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| OBINUTUZUMAB 1000MG and MMF | -25.4 | 26.49 | Not reported | Not reported | Not reported |
|---|
| PLACEBO and MMF | -23.3 | 25.76 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 25.59
- value
- 41.3
- group Id
- OG001
- spread
- 24.76
- value
- 39.4
- denoms
- counts
- group Id
- OG000
- value
- 58
- group Id
- OG001
- value
- 60
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 18.28
- value
- -14.4
- group Id
- OG001
- spread
- 22.69
- value
- -8.7
- denoms
- counts
- group Id
- OG000
- value
- 55
- group Id
- OG001
- value
- 57
- units
- Participants
- title
- Week 4
- categories
- measurements
- group Id
- OG000
- spread
- 25.07
- value
- -19.9
- group Id
- OG001
- spread
- 25.22
- value
- -11.6
- denoms
- counts
- group Id
- OG000
- value
- 57
- group Id
- OG001
- value
- 60
- units
- Participants
- title
- Week 12
- categories
- measurements
- group Id
- OG000
- spread
- 25.17
- value
- -25.0
- group Id
- OG001
- spread
- 24.74
- value
- -20.8
- denoms
- counts
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 56
- units
- Participants
- title
- Week 24
- categories
- measurements
- group Id
- OG000
- spread
- 25.71
- value
- -24.8
- group Id
- OG001
- spread
- 25.04
- value
- -19.6
- denoms
- counts
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 57
- units
- Participants
- title
- Week 36
- categories
- measurements
- group Id
- OG000
- spread
- 26.49
- value
- -25.4
- group Id
- OG001
- spread
- 25.76
- value
- -23.3
- denoms
- counts
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 56
- units
- Participants
- title
- Week 52
- denoms
- counts
- group Id
- OG000
- value
- 63
- group Id
- OG001
- value
- 62
- units
- Participants
- description
- Each VAS had a range from 0-100 with higher scores indicating greater symptom impact on global health status.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose was up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, could use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants could receive 1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants received 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
- id
- OG000
- title
- OBINUTUZUMAB 1000MG and MMF
- description
- Participants received placebo matching to obinutuzumab IV infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose was up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, could use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants could receive 1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants received 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
- id
- OG001
- title
- PLACEBO and MMF
- param Type
- MEAN
- population Description
- Modified intent-to-treat population will include all randomized participants who have received any amount of study drug. Participants who received an incorrect therapy were reported under the treatment arm to which they were randomized.
- reporting Status
- POSTED
- time Frame
- Baseline (Day 1), Weeks 4, 12, 24, 36, 52
- title
- Change From Baseline of Participant's Global Assessment of Disease Activity Visual Analog Scale (VAS) Score
- type
- SECONDARY
- unit Of Measure
- score on scale
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