Trial · NCT01408576
Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus
NCT01408576, Phase 3, Completed, UCB Pharma; results first posted 2018-10-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus. Trials, record NCT01408576. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01408576
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus
- NCT number
- NCT01408576
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,250 participants, actual
- Lead sponsor
- UCB Pharma
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Epratuzumab, Epratuzumab
- First posted
- 2011-08-03
- Last updated
- 2018-10-03
- Other registries' IDs
- eudract:2010-020859-30
- Results first posted
- 2018-10-03
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks) | During the treatment period (through Week 96) | A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. |
| Primary | Percentage of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks) | During the treatment period (through Week 96) | A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. |
| Primary | Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks) | During the treatment period (through Week 96) | A SAE is a treatment-emergent adverse event (TEAE) that the investigator classifies as serious. This includes: * Death * Life-threatening * Significant or persistent disability/incapacity * Congenital anomaly/birth defect (including that occurring in a fetus) * Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious * Initial inpatient hospitalization or prolongation of hospitalization |
| Primary | Percentage of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks) | During the treatment period (through Week 96) | A SAE is a treatment-emergent adverse event (TEAE) that the investigator classifies as serious. This includes: * Death * Life-threatening * Significant or persistent disability/incapacity * Congenital anomaly/birth defect (including that occurring in a fetus) * Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious * Initial inpatient hospitalization or prolongation of hospitalization |
| Secondary | Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index | At Week 48 | Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials. |
| Secondary | Percentage of Subjects Meeting Treatment Response Criteria According to a Combined Response Index | Week 48 | Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials. |
| Secondary | Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index | Week 96 | Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials. |
| Secondary | The Percent of Subjects Meeting Treatment Response Criteria According to a Combined Response Index | Week 96 | Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks) | During the treatment period (through Week 96) | Safety Set (SS) which consisted of all subjects who had received at least 1 partial dose of study medication during SL0012. A partial dose of study medication was defined as any infusion during which the subject received more than (\>) 0mL of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks) | During the treatment period (through Week 96) | Safety Set (SS) which consisted of all subjects who had received at least 1 partial dose of study medication during SL0012. A partial dose of study medication was defined as any infusion during which the subject received \>0mL of study medication. | percentage of participants | NUMBER |
| PRIMARY | Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks) | During the treatment period (through Week 96) | Safety Set (SS) which consisted of all subjects who had received at least 1 partial dose of study medication during SL0012. A partial dose of study medication was defined as any infusion during which the subject received \>0mL of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks) | During the treatment period (through Week 96) | Safety Set (SS) which consisted of all subjects who had received at least 1 partial dose of study medication during SL0012. A partial dose of study medication was defined as any infusion during which the subject received \>0mL of study medication. | percentage of participants | NUMBER |
| SECONDARY | Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index | At Week 48 | The Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365) or SL0010 (NCT01261793) prior to enrollment in SL0012. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects Meeting Treatment Response Criteria According to a Combined Response Index | Week 48 | The Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365) or SL0010 (NCT01261793) prior to enrollment in SL0012. | percentage of participants | NUMBER |
| SECONDARY | Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index | Week 96 | The Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365) or SL0010 (NCT01261793) prior to enrollment in SL0012, and with available results at the Week 96 time-point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Percent of Subjects Meeting Treatment Response Criteria According to a Combined Response Index | Week 96 | The Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365) or SL0010 (NCT01261793) prior to enrollment in SL0012, and with available results at the Week 96 time-point. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks) | Enrollment Cohort 1 Epratuzumab 600 mg Per Week (ES) | 26 | Participants | ||
| Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks) | Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES) | 45 | Participants | ||
| Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks) | Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES) | 25 | Participants | ||
| Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks) | All Epratuzumab 600 mg Per Week | 51 | Participants | ||
| Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks) | All Subjects | 96 | Participants | ||
| Percentage of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks) | Enrollment Cohort 1 Epratuzumab 600 mg Per Week | 10.7 | percentage of participants | ||
| Percentage of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks) | Enrollment Cohort 2 Epratuzumab 1200 mg Q2W | 9.1 | percentage of participants | ||
| Percentage of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks) | Enrollment Cohort 2 Epratuzumab 600 mg Per Week | 4.9 | percentage of participants | ||
| Percentage of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks) | All Epratuzumab 600 mg Per Week | 6.8 | percentage of participants | ||
| Percentage of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks) | All Subjects | 7.7 | percentage of participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Enrollment Cohort 1 Epratuzumab 600 mg Per Week (ES) | 244 | |
| Overall Study | STARTED | Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES) | 498 | |
| Overall Study | STARTED | Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES) | 508 | |
| Overall Study | COMPLETED | Enrollment Cohort 1 Epratuzumab 600 mg Per Week (ES) | 56 | |
| Overall Study | COMPLETED | Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES) | 0 | |
| Overall Study | COMPLETED | Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES) | 0 | |
| Overall Study | NOT COMPLETED | Enrollment Cohort 1 Epratuzumab 600 mg Per Week (ES) | 188 | |
| Overall Study | NOT COMPLETED | Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES) | 498 | |
| Overall Study | NOT COMPLETED | Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES) | 508 |
Source ClinicalTrials.gov
Adverse events1,660
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 | Enrollment Cohort 1 Epratuzumab 600 mg Per Week | 39 | 244 | 80 |
| other | Nausea | Gastrointestinal disorders | Enrollment Cohort 2 Epratuzumab 1200 mg Q2W | 59 | 497 | 86 |
| other | Nausea | Gastrointestinal disorders | Enrollment Cohort 2 Epratuzumab 600 mg Per Week | 62 | 507 | 79 |
| other | Nausea | Gastrointestinal disorders | All Epratuzumab 600 mg Per Week | 101 | 751 | 159 |
| other | Nausea | Gastrointestinal disorders | All Subjects | 160 | 1,248 | 245 |
| other | Diarrhoea | Gastrointestinal disorders | Enrollment Cohort 1 Epratuzumab 600 mg Per Week | 27 | 244 | 41 |
| other | Diarrhoea | Gastrointestinal disorders | Enrollment Cohort 2 Epratuzumab 1200 mg Q2W | 47 | 497 | 58 |
| other | Diarrhoea | Gastrointestinal disorders | Enrollment Cohort 2 Epratuzumab 600 mg Per Week | 34 | 507 | 47 |
| other | Diarrhoea | Gastrointestinal disorders | All Epratuzumab 600 mg Per Week | 61 | 751 | 88 |
| other | Diarrhoea | Gastrointestinal disorders | All Subjects | 108 | 1,248 | 146 |
1 to 10 of 1,660Source ClinicalTrials.gov
See all 1,660 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Enrollment Cohort 1 Epratuzumab 600 mg Per Week | 4 | 244 |
| Total, all-cause mortality | Enrollment Cohort 2 Epratuzumab 1200 mg Q2W | 4 | 497 |
| Total, all-cause mortality | Enrollment Cohort 2 Epratuzumab 600 mg Per Week | 1 | 507 |
| Total, all-cause mortality | All Epratuzumab 600 mg Per Week | 5 | 751 |
| Total, all-cause mortality | All Subjects | 9 | 1,248 |
| Total, other adverse events | Enrollment Cohort 1 Epratuzumab 600 mg Per Week | 177 | 244 |
| Total, other adverse events | Enrollment Cohort 2 Epratuzumab 1200 mg Q2W | 296 | 497 |
| Total, other adverse events | Enrollment Cohort 2 Epratuzumab 600 mg Per Week | 306 | 507 |
| Total, other adverse events | All Epratuzumab 600 mg Per Week | 483 | 751 |
| Total, other adverse events | All Subjects | 779 | 1,248 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01408576
GET https://conductscience.org/api/trials/v1/NCT01408576/results?page=2