Trial · NCT03283085
A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
NCT03283085, Phase 3, Completed, Shire; results first posted 2024-06-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA). Trials, record NCT03283085. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03283085
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
- NCT number
- NCT03283085
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 557 participants, actual
- Lead sponsor
- Shire
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Interventions
- 25 mg Ontamalimab, 75 mg Ontamalimab
- First posted
- 2017-09-14
- Last updated
- 2024-06-21
- Other registries' IDs
- eudract:2017-000574-11
- Results first posted
- 2024-06-21
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From first dose of study drug up to end of study [EOS] (up to 5.79 years) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs (TEAEs) were defined as AEs with start dates or worsening dates at the time of or following the first exposure to investigational product. |
| Primary | Number of Participants With Serious Infections | From first dose of study drug up to EOS (up to 5.79 years) | Serious infections were defined as any infections that were life-threatening or those requiring hospitalization or intravenous antibiotics based on the investigator's assessment. |
| Primary | Number of Participants With Notable Changes in Clinical Laboratory Parameters Over Time | From first dose of study drug up to EOS (up to 5.79 years) | Clinical laboratory assessments included hematology, serum chemistry and urinalysis. Any notable changes in the clinical laboratory value over time based on the investigator interpretation were reported. |
| Primary | Number of Participants With Discernible Changes in Electrocardiogram (ECG) Over Time | From first dose of study drug up to EOS (up to 5.79 years) | ECG included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals parameters measurement. Any discernible changes in the ECG value over time based on investigator interpretation were reported. |
| Primary | Number of Participants With Discernible Changes in Vital Signs Over Time | From first dose of study drug up to EOS (up to 5.79 years) | Vital sign assessments included blood pressure, pulse, respiratory rate, and temperature. Any discernible changes in vital signs over time per investigator interpretation were reported. |
| Secondary | Number of Participants With Ulcerative Colitis With Treatment Response Over Time | Up to 5.79 years | Treatment response over time was defined as clinical composite score that has decreased by greater than or equal to (≥2) points and ≥30 percentage (%), with an accompanying decrease in the sub score for rectal bleeding (RB) ≥1 point or a subscore for RB ≤ 1, and/or composite score that has decreased by ≥30% and ≥3 points compared to the baseline value for induction studies. The clinical composite score is a measure consisting of sub scores RB (0-3) plus stool frequency (0-3) with higher scores indicating more severe disease. With the implementation of amendment 4 of the protocol the study became a single arm study with all participants receiving the 75 mg dose of ontamalimab. Hence, only those UC participants who were receiving the 75 mg dose of ontamalimab every 4 weeks and participating in amendment 4 of the protocol were analyzed in this outcome measure. |
| Secondary | Number of Participants With Crohn's Disease With Treatment Response Over Time | Up to 5.79 years | Treatment response over time=Crohn's Disease Activity Index(CDAI)score that has decreased ≥100 points and/or simple endoscopic score for Crohn's disease(SES-CD)that has decreased by ≥25%,both compared to baseline value for induction studies.SES-CD is simple scoring system with 4 endoscopic variables measured in same 5 ileocolonic segments as CD index of severity. Overall values on SES-CD range from 0-56,higher values=more severe disease.4 endoscopic variables are scored from 0-3 in each bowel segment:ileum,right/transverse/left colon,rectum. Presence \& size of ulcers(none=0;diameter 0.1-0.5centimeter(cm)=1;0.5-2cm=2;\>2cm=3);extent of ulcerated surface(none=0;\<10%=1;10%-30%=2; \>30%= 3);extent of affected surface(none=0;\<50%=1;50%-75%=2;\>75%=3);Presence \& type of narrowing (none=0;single can be passed=1;multiple can be passed=2;cannot be passed=3). |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From first dose of study drug up to end of study [EOS] (up to 5.79 years) | The Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious Infections | From first dose of study drug up to EOS (up to 5.79 years) | The Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Notable Changes in Clinical Laboratory Parameters Over Time | From first dose of study drug up to EOS (up to 5.79 years) | The Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Discernible Changes in Electrocardiogram (ECG) Over Time | From first dose of study drug up to EOS (up to 5.79 years) | The Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Discernible Changes in Vital Signs Over Time | From first dose of study drug up to EOS (up to 5.79 years) | The Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Ulcerative Colitis With Treatment Response Over Time | Up to 5.79 years | Full Analysis Set (FAS) included all participants in the randomized set who received at least 1 dose of IP in the SHP647-304 study. Overall number analyzed is the number of UC participants with data available for analyses. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Crohn's Disease With Treatment Response Over Time | Up to 5.79 years | FAS included all participants in randomized set who received at least 1 dose of IP in the SHP647-304 study. With implementation of protocol amendment 4 this became a single arm study with all participants receiving 75 mg ontamalimab. Hence, only those CD participants who were receiving ontamalimab 75mg Q4W and participating in amendment 4 of the protocol were analyzed. Overall number analyzed is the number of CD participants with data available for analyses. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | UC: Ontamalimab 25 mg | 67 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | UC: Ontamalimab 25 mg Then 75 mg | 122 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | UC: Ontamalimab 75 mg | 203 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | CD: Ontamalimab 25 mg | 4 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | CD: Ontamalimab 25 mg Then 75 mg | 8 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | CD: Ontamalimab 75 mg | 17 | Participants | ||
| Number of Participants With Serious Infections | UC: Ontamalimab 25 mg | 5 | Participants | ||
| Number of Participants With Serious Infections | UC: Ontamalimab 25 mg Then 75 mg | 4 | Participants | ||
| Number of Participants With Serious Infections | UC: Ontamalimab 75 mg | 17 | Participants | ||
| Number of Participants With Serious Infections | CD: Ontamalimab 25 mg | 0 | Participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | UC: Ontamalimab 25 mg | 89 | |
| Overall Study | STARTED | UC: Ontamalimab 25 mg Then 75 mg | 159 | |
| Overall Study | STARTED | UC: Ontamalimab 75 mg | 268 | |
| Overall Study | STARTED | CD: Ontamalimab 25 mg | 5 | |
| Overall Study | STARTED | CD: Ontamalimab 25 mg Then 75 mg | 10 | |
| Overall Study | STARTED | CD: Ontamalimab 75 mg | 26 | |
| Overall Study | COMPLETED | UC: Ontamalimab 25 mg | 0 | |
| Overall Study | COMPLETED | UC: Ontamalimab 25 mg Then 75 mg | 117 | |
| Overall Study | COMPLETED | UC: Ontamalimab 75 mg | 129 | |
| Overall Study | COMPLETED | CD: Ontamalimab 25 mg | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events744
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 | Abdominal pain | Gastrointestinal disorders | UC: Ontamalimab 25 mg | 2 | 89 | |
| other | Abdominal pain | Gastrointestinal disorders | UC: Ontamalimab 25mg Then 75 mg | 11 | 159 | |
| other | Abdominal pain | Gastrointestinal disorders | UC: Ontamalimab 75mg | 8 | 268 | |
| other | Abdominal pain | Gastrointestinal disorders | CD: Ontamalimab 25 mg | 0 | 5 | |
| other | Abdominal pain | Gastrointestinal disorders | CD: Ontamalimab 25 mg Then 75 mg | 0 | 10 | |
| other | Abdominal pain | Gastrointestinal disorders | CD: Ontamalimab 75 mg | 2 | 26 | |
| other | Anaemia | Blood and lymphatic system disorders | UC: Ontamalimab 25 mg | 7 | 89 | |
| other | Anaemia | Blood and lymphatic system disorders | UC: Ontamalimab 25mg Then 75 mg | 14 | 159 | |
| other | Anaemia | Blood and lymphatic system disorders | UC: Ontamalimab 75mg | 16 | 268 | |
| other | Anaemia | Blood and lymphatic system disorders | CD: Ontamalimab 25 mg | 0 | 5 |
1 to 10 of 744Source ClinicalTrials.gov
See all 744 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | UC: Ontamalimab 25 mg | 0 | 89 |
| Total, all-cause mortality | UC: Ontamalimab 25mg Then 75 mg | 0 | 159 |
| Total, all-cause mortality | UC: Ontamalimab 75mg | 3 | 268 |
| Total, all-cause mortality | CD: Ontamalimab 25 mg | 1 | 5 |
| Total, all-cause mortality | CD: Ontamalimab 25 mg Then 75 mg | 0 | 10 |
| Total, all-cause mortality | CD: Ontamalimab 75 mg | 0 | 26 |
| Total, other adverse events | UC: Ontamalimab 25 mg | 47 | 89 |
| Total, other adverse events | UC: Ontamalimab 25mg Then 75 mg | 109 | 159 |
| Total, other adverse events | UC: Ontamalimab 75mg | 155 | 268 |
| Total, other adverse events | CD: Ontamalimab 25 mg | 3 | 5 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CD: Ontamalimab 25 mg Then 75 mg vs CD: Ontamalimab 75 mg: Number of Participants With Crohn's Disease With Treatment Response Over Time | Trial comparisons |
| UC: Ontamalimab 25 mg Then 75 mg vs UC: Ontamalimab 75 mg: Number of Participants With Ulcerative Colitis With Treatment Response Over Time | 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/NCT03283085
GET https://conductscience.org/api/trials/v1/NCT03283085/results?page=2