Trial · NCT02118584
Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies
NCT02118584, Phase 3, Terminated, Hoffmann-La Roche; results first posted 2024-10-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies. Trials, record NCT02118584. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02118584
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies
- NCT number
- NCT02118584
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,822 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Ulcerative Colitis
- Interventions
- Etrolizumab
- First posted
- 2014-04-21
- Last updated
- 2024-10-23
- Other registries' IDs
- eudract:2013-004435-72
- Results first posted
- 2024-10-23
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) | Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 weeks | The pMCS is a composite of 3 assessments, each rated from 0 (none) to 3 (severe disease): stool frequency, rectal bleeding, and physician's global assessment. The total score for pMCS ranges from 0 (none) to 9 (severe disease). pMCS clinical remission was defined as pMCS ≤ 2, a rectal bleeding score of 0-1, physician's global assessment of 0-1, stool frequency subscore of 0-1. Percentages have been rounded off. |
| Primary | Part 1: Percentage of Participants With Remission as Determined by the Mayo Clinic Score (MCS) | At OLE Week 108 | The Mayo Clinic scoring system is a composite of 4 assessments for UC disease activity. The 4 component sub-scores are: 1) stool frequency, 2) rectal bleeding, 3) flexible sigmoidoscopy scores, and 4) physician's global assessment, each rated from 0-3, 0 representing no pathology to 3 for severe disease. The minimum Mayo Score is 0 (no pathology) and the maximum is 12 (severe disease). MCS remission was defined as MCS ≤ 2, a rectal bleeding score of 0, physician's global assessment of 0-1, stool frequency subscore of 0-1 and endoscopy score of 0-1. Percentage has been rounded off. |
| Primary | Part 1: Percentage of Participants With Endoscopic Remission | At OLE Week 108 | The Mayo scoring system is a composite of 4 assessments for UC disease activity. The 4 component sub-scores are: 1) stool frequency, 2) rectal bleeding, 3) flexible sigmoidoscopy scores, and 4) physician's global assessment, each rated from 0-3, 0 representing no pathology to 3 for severe disease. The minimum Mayo Score is 0 (no pathology) and the maximum is 12 (severe disease). Endoscopic remission was defined as Mayo Endoscopic subscore = 0. Percentage has been rounded off. |
| Primary | Part 1: Number of Participants With Adverse Events (AEs) and Severity of AEs Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [NCI CTCAE v4.0] | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) | An AE is any untoward medical occurrence in participant administered a pharmaceutical product \& regardless of causal relationship with this treatment. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. AEs were graded as per NCI CTCAE v4.0. Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4=Life-threatening consequences/urgent intervention indicated; Grade 5=Death related to adverse event. |
| Primary | Part 1: Number of Participants With Serious Adverse Events (SAEs) | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigation, whether or not considered related to the medicinal (investigational) product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above. |
| Primary | Part 1: Number of Participants With Infection Related AEs and Severity of Infection-Related AEs Assessed Using NCI CTCAE v4.0 | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) | An AE is any untoward medical occurrence in participant administered a pharmaceutical product \& regardless of causal relationship with this treatment. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. AEs were graded as per NCI CTCAE v4.0. Grade 1= Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4=Life-threatening consequences/urgent intervention indicated; Grade 5=Death related to adverse event. |
| Primary | Part 1: Number of Participants With Serious Infection Related AES | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above. |
| Primary | Part 1: Number of Participants With Injection Site Reactions and Severity of Injection Site Reactions Assessed Using NCI CTCAE v4.0 | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) | AE=untoward medical occurrence in participant administered a pharmaceutical product \& regardless of causal relationship with this treatment. AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. Injection-site reaction=any local reaction occurring at the site of injection following study drug administration. Signs (e.g., erythema, induration/swelling at injection site) and symptoms (e.g., pain, pruritus at injection site). Injection site reactions. were graded as per NCI CTCAE v4.0. Grade 1=Tenderness with or without associated symptoms (e.g., warmth, erythema, itching); Grade 2=Pain; lipodystrophy; edema; phlebitis; Grade 3=Ulceration or necrosis; severe tissue damage; operative intervention indicated; Grade 4=life-threatening consequences or urgent intervention indicated; Grade=5 death related to AE. |
| Primary | Part 1: Number of Participants With AEs Leading to Etrolizumab Discontinuation | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a Etrolizumab, whether or not considered related to the medicinal (investigational) product. Number of participants who discontinued etrolizumab treatment during the OLE period have been reported here. |
| Primary | Part 1: Number of Participants With Malignancies | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Number of participants who developed malignancies during the OLE period have been reported here. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) | Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 weeks | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point. | percentage of participants | NUMBER |
| PRIMARY | Part 1: Percentage of Participants With Remission as Determined by the Mayo Clinic Score (MCS) | At OLE Week 108 | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. Overall number analyzed is the number of participants with data available for analysis. | percentage of participants | NUMBER |
| PRIMARY | Part 1: Percentage of Participants With Endoscopic Remission | At OLE Week 108 | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. Overall number analyzed is the number of participants with data available for analysis. | percentage of participants | NUMBER |
| PRIMARY | Part 1: Number of Participants With Adverse Events (AEs) and Severity of AEs Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [NCI CTCAE v4.0] | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Serious Adverse Events (SAEs) | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Infection Related AEs and Severity of Infection-Related AEs Assessed Using NCI CTCAE v4.0 | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Serious Infection Related AES | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Injection Site Reactions and Severity of Injection Site Reactions Assessed Using NCI CTCAE v4.0 | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With AEs Leading to Etrolizumab Discontinuation | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Malignancies | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group59
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) | Part 1 (OLE): Etrolizumab | Baseline | 32.0 | percentage of participants | |
| Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) | Part 1 (OLE): Etrolizumab | Week 4 | 47.2 | percentage of participants | |
| Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) | Part 1 (OLE): Etrolizumab | Week 8 | 52.2 | percentage of participants | |
| Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) | Part 1 (OLE): Etrolizumab | Week 12 | 55.9 | percentage of participants | |
| Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) | Part 1 (OLE): Etrolizumab | Week 24 | 63.7 | percentage of participants | |
| Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) | Part 1 (OLE): Etrolizumab | Week 36 | 68.3 | percentage of participants | |
| Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) | Part 1 (OLE): Etrolizumab | Week 48 | 73.4 | percentage of participants | |
| Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) | Part 1 (OLE): Etrolizumab | Week 60 | 72.2 | percentage of participants | |
| Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) | Part 1 (OLE): Etrolizumab | Week 72 | 75.4 | percentage of participants | |
| Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) | Part 1 (OLE): Etrolizumab | Week 84 | 76.5 | percentage of participants |
1 to 10 of 59Source ClinicalTrials.gov
See all 59 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1: Open Label Extension Period | STARTED | Part 1 (OLE): Etrolizumab Only | 1,026 | |
| Part 1: Open Label Extension Period | STARTED | Part 1 (OLE) to Part 2 (PML SM) | 747 | |
| Part 1: Open Label Extension Period | STARTED | Part 2 (PML SM) Only | 0 | |
| Part 1: Open Label Extension Period | COMPLETED | Part 1 (OLE): Etrolizumab Only | 9 | |
| Part 1: Open Label Extension Period | COMPLETED | Part 1 (OLE) to Part 2 (PML SM) | 747 | |
| Part 1: Open Label Extension Period | COMPLETED | Part 2 (PML SM) Only | 0 | |
| Part 1: Open Label Extension Period | NOT COMPLETED | Part 1 (OLE): Etrolizumab Only | 1,017 | |
| Part 1: Open Label Extension Period | NOT COMPLETED | Part 1 (OLE) to Part 2 (PML SM) | 0 | |
| Part 1: Open Label Extension Period | NOT COMPLETED | Part 2 (PML SM) Only | 0 | |
| Part 2: PML Safety Monitoring Period | STARTED | Part 1 (OLE): Etrolizumab Only | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events502
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 | Anaemia | Blood and lymphatic system disorders | Part 1 (OLE): Etrolizumab | 128 | 1,773 | 149 |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 (PML SM) | 0 | 796 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Part 1 (OLE): Etrolizumab | 98 | 1,773 | 117 |
| other | Abdominal pain | Gastrointestinal disorders | Part 2 (PML SM) | 0 | 796 | 0 |
| other | Colitis ulcerative | Gastrointestinal disorders | Part 1 (OLE): Etrolizumab | 587 | 1,773 | 882 |
| other | Colitis ulcerative | Gastrointestinal disorders | Part 2 (PML SM) | 2 | 796 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Part 1 (OLE): Etrolizumab | 95 | 1,773 | 114 |
| other | Diarrhoea | Gastrointestinal disorders | Part 2 (PML SM) | 0 | 796 | 0 |
| other | COVID-19 | Infections and infestations | Part 1 (OLE): Etrolizumab | 165 | 1,773 | 178 |
| other | COVID-19 | Infections and infestations | Part 2 (PML SM) | 0 | 796 | 0 |
1 to 10 of 502Source ClinicalTrials.gov
See all 502 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1 (OLE): Etrolizumab | 9 | 1,773 |
| Total, all-cause mortality | Part 2 (PML SM) | 1 | 796 |
| Total, other adverse events | Part 1 (OLE): Etrolizumab | 1,052 | 1,773 |
| Total, other adverse events | Part 2 (PML SM) | 2 | 796 |
| Total, serious adverse events | Part 1 (OLE): Etrolizumab | 373 | 1,773 |
| Total, serious adverse events | Part 2 (PML SM) | 2 | 796 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32445184 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Part 1 (OLE): Etrolizumab vs Part 2 (PML SM): deaths from any cause | Trial comparisons |
| Part 1 (OLE): Etrolizumab vs Part 2 (PML SM): serious adverse events | Trial comparisons |
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.
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GET https://conductscience.org/api/trials/v1/NCT02118584/results?page=2