Trial · NCT03398148
Outcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score | Week 12 | ITT1A includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Substudy 1.~ITT1B includes all the additional subjects who received at least one dose of risankizumab 1800 mg IV treatment group after 240 subjects were randomized during Induction Period 1 from Substudy 1. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Sub-Study 2: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score | Week 12 | ITT2 population. | percentage of participants | NUMBER |
| SECONDARY | Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement | Week 12 | Includes ITT1A and ITT1B populations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Full Mayo Score in Participants With a Full Mayo Score of 6 to 12 at Baseline | Week 12 | No data was collected. | ||
| SECONDARY | Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score | Week 12 | Includes ITT1A and ITT1B populations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score | Week 4 | Includes ITT1A and ITT1B populations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission | Week 12 | Includes ITT1A and ITT1B populations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Sub-Study 1: Percentage of Participants With Hospitalization | Through Week 12 | Includes ITT1A and ITT1B populations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Sub-Study 1: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR) | Week 12 | Includes ITT1A and ITT1B populations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Sub-Study 1: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ) | Baseline Through Week 12 | Includes ITT1A and ITT1B participants with data available for analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) | Baseline Through Week 12 | Includes ITT1A and ITT1B participants with data available for analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Sub-Study 1: Change From Baseline in Short Form-36 (SF-36) - Physical Component | Baseline Through Week 12 | Includes ITT1A and ITT1B participants with data available for analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Sub-Study 1: Change From Baseline in Short Form-36 (SF-36) - Mental Component | Baseline through Week 12 | Includes ITT1A and ITT1B participants with data available for analysis. | unites on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | Baseline Through Week 12 | Includes ITT1A and ITT1B participants with data available for analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Sub-Study 1: Percentage of Participants Undergoing Ulcerative Colitis (UC)-Related Surgeries | Through Week 12 | Includes ITT1A and ITT1B populations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Sub-Study 2: Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score | Week 12 | ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2. | percentage of participants | NUMBER |
| SECONDARY | Sub-Study 2: Percentage of Participants Achieving Endoscopic Improvement | Week 12 | ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2. | percentage of participants | NUMBER |
| SECONDARY | Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement (HEMI) | Week 12 | ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2. | percentage of participants | NUMBER |
| SECONDARY | Sub-Study 2: Percentage of Participants Achieving Endoscopic Remission | Week 12 | ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2. | percentage of participants | NUMBER |
| SECONDARY | Sub-Study 2: Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score at Week 4 | Week 4 | ITT2 includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 2. | percentage of participants | NUMBER |
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/NCT03398148/outcomes