Trial · NCT03259308
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 | Number of Participants With Remission Based on Composite Score at Week 12 | At Week 12 | Full analysis set (FAS) consisted of all participants in the randomized set who had received at least 1 dose of investigational product (IP). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Endoscopic Remission at Week 12 | At Week 12 | FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Remission at Week 12 | At Week 12 | FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response Based on Composite Score at Week 12 | At Week 12 | FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Mucosal Healing Based on Endoscopic and Histological Assessment Using the Geboes Score Grading System at Week 12 | At Week 12 | FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Remission Based on Total Mayo Score at Week 12 | At Week 12 | FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response Based on Total Mayo Score at Week 12 | At Week 12 | FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Partial Mayo Score <=2 With no Individual Sub-score Greater Than (>) 1 at Weeks 4, 8, and 12 | At Weeks 4, 8, and 12 | FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Remission With Stool Frequency Sub-scores of 0 or 1 and Rectal Bleeding Sub-score of 0 at Weeks 4 and 8 | At Weeks 4 and 8 | FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Endoscopic Remission With Sub-score of 0 at Week 12 | At Week 12 | FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Remission With Both Rectal Bleeding and Stool Frequency Sub-scores of 0 at Weeks 4, 8, and 12 | At Weeks 4, 8, and 12 | FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Deep Remission at Week 12 | At Week 12 | FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Average Worst Abdominal Pain Score Based on Patient Reported Outcome-ulcerative Colitis (PRO-UC) Daily e-Diary at Week 12 | Baseline, Week 12 | FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Diarrhea (Average Loose Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12 | Baseline, Week 12 | FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Average Bowel Movements With Urgency Score Based on PRO-UC Daily e-Diary at Week 12 | Baseline, Week 12 | FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Absolute Stool Frequency (Average Number of Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12 | Baseline, Week 12 | FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Absolute Rectal Bleeding (Average Number Bowel Movements With Blood) Score Based on PRO-UC Daily e-Diary at Week 12 | Baseline, Week 12 | FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Total Sign/Symptom Score Based on PRO-UC Daily e-Diary at Week 12 | Baseline, Week 12 | FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains Scores at Weeks 8 and 12 | Baseline, Weeks 8 and 12 | FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed refer to participants evaluable at specific time point. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in IBDQ Total Scores at Weeks 8 and 12 | Baseline, Weeks 8 and 12 | FAS consisted of all participants in the randomized set who had received at least 1 dose of IP. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed refer to participants evaluable at specific time point. | Score on a Scale | LEAST_SQUARES_MEAN |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03259308/outcomes