Trial · NCT03107793
Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab
NCT03107793, Phase 3, Completed, Janssen-Cilag Ltd.; results first posted 2021-05-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab. Trials, record NCT03107793. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03107793
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab
- NCT number
- NCT03107793
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 500 participants, actual
- Lead sponsor
- Janssen-Cilag Ltd.
- Conditions
- Crohn Disease
- Interventions
- Ustekinumab
- First posted
- 2017-04-11
- Last updated
- 2025-04-29
- Other registries' IDs
- eudract:2016-002918-43
- Results first posted
- 2021-05-19
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Endoscopic Response at Week 48 | Week 48 | Endoscopic response defined as showing a reduction from baseline in simple endoscopic score for Crohn's disease (SES-CD) of greater than or equal to (\>=) 50 percent (%). SES-CD is a validated instrument reflecting an endoscopist global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. Total SES-CD is sum of 4 variables for all 5 bowel segments. Scores range from 0-60 with higher scores indicating more severe disease. Randomized participants who stopped treatment before reaching Week 48 due to any reason, or participants without endoscopic data at Week 48 were analyzed as nonresponders. |
| Secondary | Percentage of Participants With Endoscopic Response at Week 48 (Premature Drop-outs Excluded) | Week 48 | Endoscopic response defined as showing a reduction from baseline in SES-CD (a validated instrument reflecting an endoscopist's global appraisal of mucosal lesions) score of \>=50%. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. Total SES-CD is calculated as sum of 4 variables for 5 bowel segments. Scores ranges 0-60. Higher scores indicates more severe disease. Randomized participants who stopped treatment before reaching Week 48 due to reasons other than lack/loss of efficacy were excluded from analysis. |
| Secondary | Percentage of Participants With Endoscopic Response at Week 48 (Last Observation Carried Forward [LOCF]) | Week 48 (LOCF) | Endoscopic response defined as a reduction from baseline in SES-CD score of \>= 50%. SES-CD is a validated instrument reflecting an endoscopist global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. The total SES-CD was calculated as the sum of the 4 variables for the 5 bowel segments. Scores range from 0 to 60, with higher scores indicating more severe disease. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. |
| Secondary | Percentage of Participants With Clinical Response at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) | Weeks 16, 48, and Endpoint (Week 48 [LOCF]) | Clinical response defined as a \>=100-point reduction from the baseline in Crohn's Disease Activity Index (CDAI) score, or a CDAI score of \<150. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. Participants with missing data were considered as non-responder. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study). |
| Secondary | Percentage of Participants With Clinical Remission at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) | Weeks 16, 48, and Endpoint (Week 48 [LOCF]) | Clinical Remission defined as a CDAI score of \<150 points. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. Participants with missing data were considered as non-remitter. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study). |
| Secondary | Percentage of Participants With Endoscopic Remission at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) | Weeks 16, 48, and Endpoint (Week 48 [LOCF]) | Percentage of participants with Endoscopic remission defined as SES-CD score \<=2 at Weeks 16, 48, and Endpoint (Week 48 \[LOCF\]) were reported. SES-CD is a validated instrument reflecting an endoscopist global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. Total SES-CD is sum of 4 variables for all 5 bowel segments. Scores range from 0-60 with higher scores indicating more severe disease. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study). |
| Secondary | Percentage of Participants With Mucosal Healing at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) | Weeks 16, 48, and Endpoint (Week 48 [LOCF]) | Mucosal healing is defined as the complete absence of mucosal ulcerations in any ileocolonic segment. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. Total SES-CD is sum of 4 variables for all 5 bowel segments. Scores range from 0-60 with higher scores indicating more severe disease. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (i.e. first 48 weeks of the study). |
| Secondary | Percentage of Participants With Corticosteroid-free Clinical Remission at Week 48 and Endpoint (Week 48 [LOCF]) | Week 48 and Endpoint (Week 48 [LOCF]) | Corticosteroid-free Clinical Remission at Week 48 and Endpoint (Week 48 \[LOCF\]) is defined as a CDAI score \<150 and not taking any corticosteroids for at least 30 days prior to Week 48 and Endpoint assessment. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. Participants with missing data were analyzed as non-remitter. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study). |
| Secondary | Percentage of Participants With Corticosteroid-free Endoscopic Response at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) | Weeks 16, 48, and Endpoint (Week 48 [LOCF]) | Corticosteroid-free endoscopic response defined as a reduction from baseline in SES-CD score of \>=50% and not taking any corticosteroids for at least 30 days prior to Weeks 16, 48 and endpoint (Week 48 \[LOCF\]). SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. Total score is sum of 4 variables. Scores range 0-60. Higher scores means severe disease. Participants with missing data were analyzed as No SES-CD Improvement. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint defined as last available postbaseline result within main analysis period (i.e., first 48 weeks). |
| Secondary | Change From Baseline in Serum C-reactive Protein (CRP) | Baseline, Weeks 16, 48 and Endpoint (Week 48 [LOCF] | Change from baseline in serum CRP were reported. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study). |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Endoscopic Response at Week 48 | Week 48 | Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Endoscopic Response at Week 48 (Premature Drop-outs Excluded) | Week 48 | FRAS included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. Here, 'N' (Number of participants analyzed) included participants who were evaluable for this outcome measure. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Endoscopic Response at Week 48 (Last Observation Carried Forward [LOCF]) | Week 48 (LOCF) | FRAS included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) | Weeks 16, 48, and Endpoint (Week 48 [LOCF]) | FRAS included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Remission at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) | Weeks 16, 48, and Endpoint (Week 48 [LOCF]) | FRAS included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Endoscopic Remission at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) | Weeks 16, 48, and Endpoint (Week 48 [LOCF]) | FRAS included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. Here, 'n' (number analyzed) refers participants analyzed at specified timepoints. Data was not collected for routine care arm at Week 16 as per planned analysis. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Mucosal Healing at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) | Weeks 16, 48, and Endpoint (Week 48 [LOCF]) | FRAS included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. Here, 'n' (number analyzed) is defined as number of participants who were analyzed at specified timepoints. Data was not collected for routine care arm at Week 16 as per planned analysis. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Corticosteroid-free Clinical Remission at Week 48 and Endpoint (Week 48 [LOCF]) | Week 48 and Endpoint (Week 48 [LOCF]) | FRAS included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Corticosteroid-free Endoscopic Response at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) | Weeks 16, 48, and Endpoint (Week 48 [LOCF]) | FRAS included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. Here, 'n' (number analyzed) included participants analyzed at specified timepoints. Data was not collected for routine care arm at Week 16 as per planned analysis. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in Serum C-reactive Protein (CRP) | Baseline, Weeks 16, 48 and Endpoint (Week 48 [LOCF] | FRAS included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. Here, 'N' (Number analyzed) included participants who were evaluable for this outcome measure. | Milligrams per liter (mg/L) | MEAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group171
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Endoscopic Response at Week 48 | Maintenance Period: Treat to Target | 37.9 | 95% Confidence Interval 31.4 | Percentage of Participants | |
| Percentage of Participants With Endoscopic Response at Week 48 | Maintenance Period: Routine Care | 29.9 | 95% Confidence Interval 23.9 | Percentage of Participants | |
| Percentage of Participants With Endoscopic Response at Week 48 (Premature Drop-outs Excluded) | Maintenance Period: Treat to Target | 43.0 | 95% Confidence Interval 35.9 | Percentage of Participants | |
| Percentage of Participants With Endoscopic Response at Week 48 (Premature Drop-outs Excluded) | Maintenance Period: Routine Care | 32.3 | 95% Confidence Interval 25.9 | Percentage of Participants | |
| Percentage of Participants With Endoscopic Response at Week 48 (Last Observation Carried Forward [LOCF]) | Maintenance Period: Treat to Target | 40.2 | 95% Confidence Interval 33.6 | Percentage of Participants | |
| Percentage of Participants With Endoscopic Response at Week 48 (Last Observation Carried Forward [LOCF]) | Maintenance Period: Routine Care | 30.8 | 95% Confidence Interval 24.8 | Percentage of Participants | |
| Percentage of Participants With Clinical Response at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) | Maintenance Period: Treat to Target | Week 16 | 84.5 | 95% Confidence Interval 80.0 to 89.8 | Percentage of Participants |
| Percentage of Participants With Clinical Response at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) | Maintenance Period: Routine Care | Week 16 | 89.6 | 95% Confidence Interval 84.8 to 93.3 | Percentage of Participants |
| Percentage of Participants With Clinical Response at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) | Maintenance Period: Treat to Target | Week 48 | 68.0 | 95% Confidence Interval 61.4 to 74.2 | Percentage of Participants |
| Percentage of Participants With Clinical Response at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) | Maintenance Period: Routine Care | Week 48 | 77.8 | 95% Confidence Interval 71.8 to 83.1 | Percentage of Participants |
1 to 10 of 171Source ClinicalTrials.gov
See all 171 results by groupParticipant flow55
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Period (16 Weeks) | STARTED | Induction Period: Ustekinumab (6 Milligrams [mg]/Kilogram [kg]) | 498 | |
| Induction Period (16 Weeks) | STARTED | Maintenance Period: Treat to Target | 0 | |
| Induction Period (16 Weeks) | STARTED | Maintenance Period: Routine Care | 0 | |
| Induction Period (16 Weeks) | STARTED | Extension Period: Treat to Target | 0 | |
| Induction Period (16 Weeks) | STARTED | Extension Period: Routine Care | 0 | |
| Induction Period (16 Weeks) | Participants Who Entered the Maintenance Period | Induction Period: Ustekinumab (6 Milligrams [mg]/Kilogram [kg]) | 0 | |
| Induction Period (16 Weeks) | Participants Who Entered the Maintenance Period | Maintenance Period: Treat to Target | 219 | |
| Induction Period (16 Weeks) | Participants Who Entered the Maintenance Period | Maintenance Period: Routine Care | 221 | |
| Induction Period (16 Weeks) | Participants Who Entered the Maintenance Period | Extension Period: Treat to Target | 0 | |
| Induction Period (16 Weeks) | Participants Who Entered the Maintenance Period | Extension Period: Routine Care | 0 |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 participant flowAdverse events760
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 | Induction Period | 14 | 498 | 14 |
| other | Anaemia | Blood and lymphatic system disorders | Maintenance Period: Treat to Target | 8 | 219 | 10 |
| other | Anaemia | Blood and lymphatic system disorders | Maintenance Period: Routine Care | 11 | 221 | 13 |
| other | Anaemia | Blood and lymphatic system disorders | Extension Period: Treat to Target | 8 | 147 | 10 |
| other | Anaemia | Blood and lymphatic system disorders | Extension Period: Routine Care | 8 | 176 | 10 |
| other | Vertigo | Ear and labyrinth disorders | Induction Period | 3 | 498 | 3 |
| other | Vertigo | Ear and labyrinth disorders | Maintenance Period: Treat to Target | 3 | 219 | 3 |
| other | Vertigo | Ear and labyrinth disorders | Maintenance Period: Routine Care | 2 | 221 | 2 |
| other | Vertigo | Ear and labyrinth disorders | Extension Period: Treat to Target | 3 | 147 | 3 |
| other | Vertigo | Ear and labyrinth disorders | Extension Period: Routine Care | 0 | 176 | 0 |
1 to 10 of 760Source ClinicalTrials.gov
See all 760 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Induction Period | 0 | 498 |
| Total, all-cause mortality | Maintenance Period: Treat to Target | 2 | 219 |
| Total, all-cause mortality | Maintenance Period: Routine Care | 0 | 221 |
| Total, all-cause mortality | Extension Period: Treat to Target | 0 | 147 |
| Total, all-cause mortality | Extension Period: Routine Care | 1 | 176 |
| Total, other adverse events | Induction Period | 238 | 498 |
| Total, other adverse events | Maintenance Period: Treat to Target | 158 | 219 |
| Total, other adverse events | Maintenance Period: Routine Care | 150 | 221 |
| Total, other adverse events | Extension Period: Treat to Target | 125 | 147 |
| Total, other adverse events | Extension Period: Routine Care | 135 | 176 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers4
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Maintenance Period: Treat to Target vs Maintenance Period: Routine Care: Number of Participants With Adverse Events (AEs) That Occurred in Participants Administered With Ustekinumab up to Week 48 |
Source 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/NCT03107793
GET https://conductscience.org/api/trials/v1/NCT03107793/registered?page=2