Trial · NCT02403323
Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
NCT02403323, Phase 3, Terminated, Hoffmann-La Roche; results first posted 2024-12-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144. Trials, record NCT02403323. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02403323
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
- NCT number
- NCT02403323
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 790 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Crohn Disease
- Interventions
- Etrolizumab
- First posted
- 2015-03-31
- Last updated
- 2024-12-02
- Other registries' IDs
- eudract:2014-003855-76
- Results first posted
- 2024-12-02
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Number of Participants With Crohn's Disease Activity Index (CDAI) Remission at 12-week Intervals | Day 1 and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240 and 252 of OLE | CDAI is a score obtained from composite of eight assessments: number of liquid or soft stools, abdominal pain, general well-being, presence of complications, taking lomotil (diphenoxylate/atropine) or other opiates for diarrhea, presence of an abdominal mass, hematocrit, and percentage deviation from standard weight. A decrease in CDAI over time indicates improvement in disease activity. CDAI scores range from 0 to 600. A higher score indicates worse outcome. A total score of less than 150 corresponds to remission. |
| Primary | Part 1: Number of Participants With Clinical Remission at 12-week Intervals | Day 1 and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240 and 252 of OLE | Clinical remission was defined as a liquid/soft stool frequency (SF) mean daily score ≤3 and an abdominal pain (AP) mean daily score ≤1 with no worsening in either subscore compared to baseline, where the average was taken over 7 days prior to visit. Abdominal pain severity was assessed using the abdominal pain questionnaire which is an 11-point numeric rating scale with score ranging from 0 (no pain) to 10 (worse pain). Liquid/soft stool frequency was reported using the bristol stool form scale which classifies stools into seven groups based on its consistency i.e., type 1- separate hard lumps, type 2- sausage-shaped but lumpy, type 3- like a sausage but with cracks on the surface, type 4- like a sausage or snake, smooth and soft, type 5- soft blobs with clear-cut edges, type 6- fluffy pieces with ragged edges and type 7- entirely liquid with no solid pieces. |
| Primary | Part 1: Number of Participants With Improvement in Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 108 | At OLE Week 108 | SES-CD is an endoscopic score composite of 4 variables (ulcers size, percentage of ulcerated surface, inflamed surface, and presence of narrowing) in up to 5 ileocolonic segments (ileum right, colon, transverse colon, left colon, rectum) and scored on a scale of 0-3, with total score from 0-60. Higher score indicates higher ulcer surface/size in the 4 variables. Endoscopic improvement was defined as ≥50% reduction in SES-CD score compared to baseline. |
| Primary | Part 1: Number of Participants With Adverse Event (AE) and Severity of AEs as 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 6.3 years) | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. 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 AE. Multiple occurrences of AEs in the same category at the worst (highest) NCIC-CTCAE grade for an individual are counted only once. |
| 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 6.3 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 6.3 years) | AE=untoward medical occurrence in participant administered a pharmaceutical product \& regardless of causal relationship with this treatment. AEs were graded 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. If a participant experienced multiple occurrences of AEs at different grades, they were counted in each grade where they had at least one AE of that grade. |
| Primary | Part 1: Incidence Rate of Infection-related Adverse Event | From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years) | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a 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. AE rate (per 100 participant years) = \[Total number of AEs (in OLE only) / Total number of participant years at risk (in OLE only)\]\*100. Total participant-years at risk is the sum over all participants of the time intervals (in years) from the first dose of study treatment in Part 1 (OLE) until the participant completes/withdraws from the study (including the 12-week safety follow-up, if applicable). |
| 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 6.3 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 Injection Site Reactions and Severity of Injection Site Reactions Assessed Using NCI CTCAE v4.0 | From Day 1 up to end of safety 12-week follow-up in OLE (approximately 6.3 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 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 Adverse Events Leading to Etrolizumab Discontinuation | From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years) | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a 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 discontinued etrolizumab treatment during the OLE period have been reported here. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Number of Participants With Crohn's Disease Activity Index (CDAI) Remission at 12-week Intervals | Day 1 and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240 and 252 of OLE | OLE population included all participants who received at least one dose of study drug in Study GA29145 Part 1 (OLE). Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Clinical Remission at 12-week Intervals | Day 1 and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240 and 252 of OLE | OLE population included all participants who received at least one dose of study drug in Study GA29145 Part 1 (OLE). Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Improvement in Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 108 | At OLE Week 108 | OLE population included all participants who received at least one dose of study drug in Study GA29145 Part 1 (OLE). Overall number analyzed is the number of participants with data available for analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Adverse Event (AE) and Severity of AEs as 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 6.3 years) | OLE population included all participants who received at least one dose of study drug in study GA29145 Part 1 (OLE). | 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 6.3 years) | OLE popuation included all participants who received at least one dose of study drug in study GA29145 Part 1 (OLE). | 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 6.3 years) | OLE population included all participants who received at least one dose of study drug in study GA29145 Part 1 (OLE). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Incidence Rate of Infection-related Adverse Event | From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years) | OLE population included all participants who received at least one dose of study drug in study GA29145 Part 1 (OLE). | event per 100 participant-years | NUMBER |
| 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 6.3 years) | OLE popuation included all participants who received at least one dose of study drug in study GA29145 Part 1 (OLE). | 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 safety 12-week follow-up in OLE (approximately 6.3 years) | OLE population included all participants who received at least one dose of study drug in study GA29145 Part 1 (OLE). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Adverse Events Leading to Etrolizumab Discontinuation | From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years) | OLE population included all participants who received at least one dose of study drug in study GA29145 Part 1 (OLE). | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Number of Participants With Crohn's Disease Activity Index (CDAI) Remission at 12-week Intervals | Part 1 (OLE): Etrolizumab | Day 1 | 230 | Participants | |
| Part 1: Number of Participants With Crohn's Disease Activity Index (CDAI) Remission at 12-week Intervals | Part 1 (OLE): Etrolizumab | Week 12 | 166 | Participants | |
| Part 1: Number of Participants With Crohn's Disease Activity Index (CDAI) Remission at 12-week Intervals | Part 1 (OLE): Etrolizumab | Week 24 | 165 | Participants | |
| Part 1: Number of Participants With Crohn's Disease Activity Index (CDAI) Remission at 12-week Intervals | Part 1 (OLE): Etrolizumab | Week 36 | 161 | Participants | |
| Part 1: Number of Participants With Crohn's Disease Activity Index (CDAI) Remission at 12-week Intervals | Part 1 (OLE): Etrolizumab | Week 48 | 113 | Participants | |
| Part 1: Number of Participants With Crohn's Disease Activity Index (CDAI) Remission at 12-week Intervals | Part 1 (OLE): Etrolizumab | Week 60 | 137 | Participants | |
| Part 1: Number of Participants With Crohn's Disease Activity Index (CDAI) Remission at 12-week Intervals | Part 1 (OLE): Etrolizumab | Week 72 | 124 | Participants | |
| Part 1: Number of Participants With Crohn's Disease Activity Index (CDAI) Remission at 12-week Intervals | Part 1 (OLE): Etrolizumab | Week 84 | 119 | Participants | |
| Part 1: Number of Participants With Crohn's Disease Activity Index (CDAI) Remission at 12-week Intervals | Part 1 (OLE): Etrolizumab | Week 96 | 88 | Participants | |
| Part 1: Number of Participants With Crohn's Disease Activity Index (CDAI) Remission at 12-week Intervals | Part 1 (OLE): Etrolizumab | Week 108 | 96 | Participants |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 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 | 431 | |
| Part 1: Open Label Extension Period | STARTED | Part 1 (OLE) to Part 2 (PML SM) | 320 | |
| 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 | 5 | |
| Part 1: Open Label Extension Period | COMPLETED | Part 1 (OLE) to Part 2 (PML SM) | 320 | |
| 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 | 426 | |
| 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 events374
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 | 42 | 751 | 52 |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 (PML SM) | 0 | 359 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Part 1 (OLE): Etrolizumab | 82 | 751 | 109 |
| other | Abdominal pain | Gastrointestinal disorders | Part 2 (PML SM) | 1 | 359 | 2 |
| other | Crohn's disease | Gastrointestinal disorders | Part 1 (OLE): Etrolizumab | 174 | 751 | 229 |
| other | Crohn's disease | Gastrointestinal disorders | Part 2 (PML SM) | 1 | 359 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Part 1 (OLE): Etrolizumab | 53 | 751 | 68 |
| other | Diarrhoea | Gastrointestinal disorders | Part 2 (PML SM) | 0 | 359 | 0 |
| other | Nausea | Gastrointestinal disorders | Part 1 (OLE): Etrolizumab | 52 | 751 | 63 |
| other | Nausea | Gastrointestinal disorders | Part 2 (PML SM) | 0 | 359 | 0 |
1 to 10 of 374Source ClinicalTrials.gov
See all 374 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 | 3 | 751 |
| Total, all-cause mortality | Part 2 (PML SM) | 1 | 359 |
| Total, other adverse events | Part 1 (OLE): Etrolizumab | 453 | 751 |
| Total, other adverse events | Part 2 (PML SM) | 2 | 359 |
| Total, serious adverse events | Part 1 (OLE): Etrolizumab | 206 | 751 |
| Total, serious adverse events | Part 2 (PML SM) | 1 | 359 |
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.
GET https://conductscience.org/api/trials/v1/NCT02403323
GET https://conductscience.org/api/trials/v1/NCT02403323/results?page=2