Trial · NCT03559517
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Clinical Remission Based on 2-item Patient-reported Outcome (PRO) at Week 16 | At Week 16 | Full analysis set (FAS) consisted of all randomized participants who had received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Endoscopic Response at Week 16 | At Week 16 | FAS consisted of all randomized participants who had received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score at Week 16 | At Week 16 | FAS consisted of all randomized participants who had received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Enhanced Endoscopic Response at Week 16 | At Week 16 | FAS consisted of all randomized participants who had received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Remission Based on 2-item PRO With 4-point Scale for Abdominal Pain at Week 16 | At Week 16 | FAS consisted of all randomized participants who had received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response Based on 2-item PRO With 2 Criteria at Week 16 | At Week 16 | FAS consisted of all randomized participants who had received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Remission Based on 2-Item PRO With Endoscopic Response at Week 16 | At Week 16 | FAS consisted of all randomized participants who had received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Complete Endoscopic Healing at Week 16 | At Week 16 | FAS consisted of all randomized participants who had received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response as Measured by CDAI-100 at Week 16 | At Week 16 | Study terminated early for reasons unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed. | ||
| SECONDARY | Number of Participants With Clinical Response as Measured by CDAI-70 at Week 16 | At Week 16 | Study terminated early for reasons unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed. | ||
| SECONDARY | Number of Participants With Clinical Remission Over Time | Baseline up to Week 16 | Study terminated early for reasons unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed. | ||
| SECONDARY | Change From Baseline in Individual and Total Sign/Symptom Score Based on Participant Daily Electronic Diary (E-diary) Entries at Week 16 | Baseline and at Week 16 | Study terminated early for reasons unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed. | ||
| SECONDARY | Number of Participants With Endoscopic Healing at Week 16 | At Week 16 | Study terminated early for reasons unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed. | ||
| SECONDARY | Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total (Absolute) Score at Weeks 8, 12 and 16 | Baseline, Weeks 8, 12 and 16 | Study terminated early for reasons unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed. | ||
| SECONDARY | Change From Baseline in Short Form-36 Health Survey (SF-36) Scores at Week 16 | Baseline, Week 16 | Study terminated early for reasons unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed. | ||
| SECONDARY | Number of Participants Based on Incidence of All-cause Hospitalizations | Baseline up to Week 32 | Study terminated early for reasons unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed. | ||
| SECONDARY | Number of Participants Based on Total Inpatient Days | Baseline up to Week 32 | Study terminated early for reasons unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed. | ||
| SECONDARY | Number of Participants Based on Incidence of CD-related Surgeries and Other Surgical Procedures | Baseline up to Week 32 | Study terminated early for reasons unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed. |
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.
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GET https://conductscience.org/api/trials/v1/NCT03559517/outcomes