Trial · NCT06398626
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of patients with symptomatic remission | Week 12 | Symptomatic remission is defined as partial Modified Mayo Score (pMMS) stool frequency subscore (SFS) = 0 (or = 1 with a ≥ 1-point decrease from baseline) and (RBS) rectal bleeding subscore = 0 |
| Secondary | Proportion of patients with symptomatic remission | Weeks 24, 36, 52 | Symptomatic remission is defined as partial Modified Mayo Score (pMMS) stool frequency subscore (SFS) = 0 (or = 1 with a ≥ 1-point decrease from baseline) and (RBS) rectal bleeding subscore = 0 |
| Secondary | Proportion of patients with symptomatic response | Weeks 12, 24, 36, 52 | Symptomatic response defined as a decrease from baseline ≥ 30% in pMMS composite RBS and SFS |
| Secondary | Proportion of patients with symptomatic response | Weeks 12, 24, 36, 52 | Symptomatic response defined as a decrease from baseline ≥ 20% in pMMS composite RBS and SFS |
| Secondary | Proportion of patients with clinical remission | Weeks 12, 24, 36, 52 | Clinical remission is defined as a pMMS ≤ 2 points, with no individual subscores \> 1 point. |
| Secondary | Proportion of patients with steroid-free symptomatic remission (among all patients and among patients in symptomatic remission) | Weeks 24, 36, 52 | Steroid-free symptomatic remission is defined as patients in symptomatic remission who did not take any corticosteroid treatment for 8 weeks prior to the visit/timepoint |
| Secondary | Proportion of patients with steroid-free clinical remission (among all patients and among patients in clinical remission) | Weeks 24, 36, 52 | Steroid-free clinical remission is defined as patients in clinical remission (using a pMMS) who did not take any corticosteroid treatment for 8 weeks prior to the visit/timepoint |
| Secondary | Change from baseline in fatigue | Weeks 12, 24, 36, 52 | Change from baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score Normalization of fatigue is defined as a FACIT Fatigue score ≥ 40.1 |
| Secondary | Change from baseline of bowel urgency | Weeks 12, 24, 36, 52 | Change from baseline in bowel urgency on a 0 (no urgency) - 10 (worst possible urgency) numeric rating scale |
| Secondary | Proportion of patients with a clinically meaningful improvement in bowel urgency | Weeks 12, 24, 36, 52 | Clinically meaningful improvement in bowel urgency is defined as ≥ 3-point decrease from baseline among patients with baseline bowel urgency score ≥ 3 |
| Secondary | Proportion of patients in bowel urgency remission | Weeks 12, 24, 36, 52 | Bowel urgency remission is defined as a bowel urgency score ≤ 1 among patients with a baseline bowel urgency score ≥ 3 and the overall population |
| Secondary | Proportion of patients with complete bowel urgency remission | Weeks 12, 24, 36, 52 | Complete bowel urgency remission is defined as a bowel urgency Numeric Rating Scale score = 0 |
| Secondary | Change from baseline in abdominal pain | Weeks 12, 24, 36, 52 | Change from baseline in abdominal pain on a 0 (no pain) - 10 (pain as bad as can imagine) numeric rating scale |
| Secondary | Proportion of patients with abdominal pain remission | Weeks 12, 24, 36, 52 | Abdominal pain remission is defined as an abdominal pain Numeric Rating Scale score = 0 |
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/NCT06398626/registered