Trial · NCT01261793
Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)
NCT01261793, Phase 3, Completed, UCB Pharma; results first posted 2018-06-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE). Trials, record NCT01261793. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01261793
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)
- NCT number
- NCT01261793
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 791 participants, actual
- Lead sponsor
- UCB Pharma
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Placebo, Epratuzumab, Epratuzumab
- First posted
- 2010-12-16
- Last updated
- 2020-12-04
- Other registries' IDs
- eudract:2010-018565-26
- Results first posted
- 2018-06-29
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index | At Week 48 | Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes. |
| Secondary | The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index | At Week 24 | Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes. |
| Secondary | The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index | At Week 12 | Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes. |
| Secondary | The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index | At Week 36 | Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes. |
| Secondary | Change From Baseline in Daily Corticosteroid Dose at Week 24 | At Week 24 | Participants were grouped into 4 categories: Dose decreased by \>50%, Dose decreased \>0% to ≤50%, No change in dose and Dose increased or missing data. |
| Secondary | Change From Baseline in Daily Corticosteroid Dose at Week 48 | At Week 48 | Participants were grouped into 4 categories: Dose decreased by \>50%, Dose decreased \>0% to ≤50%, No change in dose and Dose increased or missing data. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index | At Week 48 | The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug. | Percentage of responders | NUMBER |
| SECONDARY | The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index | At Week 24 | The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug. | Percentage of responders | NUMBER |
| SECONDARY | The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index | At Week 12 | The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug. | Percentage of responders | NUMBER |
| SECONDARY | The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index | At Week 36 | The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug. | Percentage of responders | NUMBER |
| SECONDARY | Change From Baseline in Daily Corticosteroid Dose at Week 24 | At Week 24 | The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug. | Percentage of subjects | NUMBER |
| SECONDARY | Change From Baseline in Daily Corticosteroid Dose at Week 48 | At Week 48 | The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index | Placebo Weekly (FAS) | 33.5 | Percentage of responders | ||
| The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index | Epratuzumab 1200 mg Every Other Week (FAS) | 34.1 | Percentage of responders | ||
| The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index | Epratuzumab 600 mg Weekly (FAS) | 35.2 | Percentage of responders | ||
| The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index | Placebo Weekly (FAS) | 32.3 | Percentage of responders | ||
| The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index | Epratuzumab 1200 mg Every Other Week (FAS) | 33.0 | Percentage of responders | ||
| The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index | Epratuzumab 600 mg Weekly (FAS) | 43.6 | Percentage of responders | ||
| The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index | Placebo Weekly (FAS) | 30.0 | Percentage of responders | ||
| The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index | Epratuzumab 1200 mg Every Other Week (FAS) | 32.2 | Percentage of responders | ||
| The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index | Epratuzumab 600 mg Weekly (FAS) | 40.9 | Percentage of responders | ||
| The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index | Placebo Weekly (FAS) | 32.7 | Percentage of responders |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Weekly (RS) | 263 | |
| Overall Study | STARTED | Epratuzumab 1200 mg Every Other Week (RS) | 262 | |
| Overall Study | STARTED | Epratuzumab 600 mg Weekly (RS) | 266 | |
| Overall Study | COMPLETED | Placebo Weekly (RS) | 178 | |
| Overall Study | COMPLETED | Epratuzumab 1200 mg Every Other Week (RS) | 171 | |
| Overall Study | COMPLETED | Epratuzumab 600 mg Weekly (RS) | 184 | |
| Overall Study | NOT COMPLETED | Placebo Weekly (RS) | 85 | |
| Overall Study | NOT COMPLETED | Epratuzumab 1200 mg Every Other Week (RS) | 91 | |
| Overall Study | NOT COMPLETED | Epratuzumab 600 mg Weekly (RS) | 82 |
Source ClinicalTrials.gov
Adverse events540
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Placebo Weekly (SS) | 36 | 263 | 51 |
| other | Nausea | Gastrointestinal disorders | Epratuzumab 1200 mg Every Other Week (SS) | 32 | 261 | 41 |
| other | Nausea | Gastrointestinal disorders | Epratuzumab 600 mg Weekly (SS) | 25 | 264 | 38 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Weekly (SS) | 19 | 263 | 24 |
| other | Diarrhoea | Gastrointestinal disorders | Epratuzumab 1200 mg Every Other Week (SS) | 15 | 261 | 15 |
| other | Diarrhoea | Gastrointestinal disorders | Epratuzumab 600 mg Weekly (SS) | 25 | 264 | 41 |
| other | Vomiting | Gastrointestinal disorders | Placebo Weekly (SS) | 16 | 263 | 18 |
| other | Vomiting | Gastrointestinal disorders | Epratuzumab 1200 mg Every Other Week (SS) | 12 | 261 | 14 |
| other | Vomiting | Gastrointestinal disorders | Epratuzumab 600 mg Weekly (SS) | 16 | 264 | 23 |
| other | Fatigue | General disorders | Placebo Weekly (SS) | 14 | 263 | 17 |
1 to 10 of 540Source ClinicalTrials.gov
See all 540 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Weekly (SS) | 3 | 263 |
| Total, all-cause mortality | Epratuzumab 1200 mg Every Other Week (SS) | 1 | 261 |
| Total, all-cause mortality | Epratuzumab 600 mg Weekly (SS) | 0 | 264 |
| Total, other adverse events | Placebo Weekly (SS) | 151 | 263 |
| Total, other adverse events | Epratuzumab 1200 mg Every Other Week (SS) | 145 | 261 |
| Total, other adverse events | Epratuzumab 600 mg Weekly (SS) | 158 | 264 |
| Total, serious adverse events | Placebo Weekly (SS) | 45 | 263 |
| Total, serious adverse events | Epratuzumab 1200 mg Every Other Week (SS) | 45 | 261 |
| Total, serious adverse events | Epratuzumab 600 mg Weekly (SS) | 50 | 264 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01261793
GET https://conductscience.org/api/trials/v1/NCT01261793/results?page=2