Trial · NCT03107793
Outcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| 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 |
| SECONDARY | Change From Baseline in Fecal Calprotectin (FC) | 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 of participants analyzed) included participants who were evaluable for this outcome measure. | Micrograms per gram (mcg/g) | MEAN |
| SECONDARY | Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Response | 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 7-point Change From Baseline in Work Productivity and Activity Impairment (WPAI) Scores for Each Domain | 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 of participants analyzed) included participants who were evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in IBDQ Score | 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 of participants analyzed) included participants who were evaluable for this outcome measure. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in European Quality Of Life 5 Dimensions 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score | 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 of participants analyzed) included participants who were evaluable for this outcome measure. | Units on a scale | MEAN |
| SECONDARY | Changes From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Scale Score | 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 of participants analyzed) included participants who were evaluable for this outcome measure. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score | 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 of participants analyzed) included participants who were evaluable for this outcome measure. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in WPAI Score | 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 of participants analyzed) included participants who were evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Time Lost From Work | 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 of participants analyzed) included participants who were evaluable for this outcome measure. | Days | MEAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) That Occurred in Participants Administered With Ustekinumab up to Week 48 | Up to 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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GET https://conductscience.org/api/trials/v1/NCT03107793/outcomes