Trial · NCT06249555
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To assess time of onset of biologic therapy in pain interference | Baseline to Week 14 | Time to meaningful clinical improvement in pain interference, defined as a ≥ 2-point decrease in the PROMIS Pain Interference-SF T-score |
| Secondary | To assess time of onset of biologic therapy in multiple QOL and functioning domains | Baseline to Weeks 14, 30, and 52 | Time to meaningful clinical improvement for each individual PROMIS domain, defined as a ≥ 2-point change in the direction of improvement in the respective PROMIS domain T-score (Note: A higher PROMIS domain T-score represents more of the concept being measured. For the Ability to Participate in Social Roles and Activities domain an increase in T-score |
| Secondary | To assess the efficacy of therapy in inducing a meaningful clinical improvement in pain interference through Week 52 through a reduction in PROMIS - Pain Interference - Short Form Scores. | Baseline to Weeks 14, 30, and 52 | Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52 |
| Secondary | To assess the efficacy of therapy in inducing a meaningful clinical improvement in fatigue through Week 52 through a reduction in PROMIS - Fatigue - Short Form Scores. | Baseline to Weeks 14, 30, and 52 | Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52 |
| Secondary | To assess the efficacy of therapy in inducing a meaningful clinical improvement in anxiety through Week 52 through a reduction in PROMIS - Emotional Distress - Anxiety - Short Form Scores. | Baseline to Weeks 14, 30, and 52 | Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52 |
| Secondary | To assess the efficacy of therapy in inducing a meaningful clinical improvement in depression through Week 52 through a reduction in PROMIS Emotional Distress - Depression - Short Form. | Baseline to Weeks 14, 30, and 52 | Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52 |
| Secondary | To assess the efficacy of therapy in inducing a meaningful clinical improvement in sleep disturbance through Week 52 through a reduction in PROMIS - Sleep Disturbance - Short Form. | Baseline to Weeks 14, 30, and 52 | Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52 |
| Secondary | To assess the efficacy of therapy in inducing a meaningful clinical improvement in physical function through Week 52 through a reduction in PROMIS - Physical Function - Short Form. | Baseline to Weeks 14, 30, and 52 | Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52 |
| Secondary | To assess the efficacy of therapy in inducing a meaningful clinical improvement in ability to participate in social roles and activities through Week 52 through a reduction in PROMIS - Ability to Participate in Social Roles and Activities - Short Form. | Baseline to Weeks 14, 30, and 52 | Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52 |
| Secondary | To assess early change in patient-reported symptoms within the PRO-2 through Week 14. | Baseline to Week 14 | Change in PRO-2 (liquid/very soft stool frequency + abdominal pain) from baseline to Week 14. |
| Secondary | To assess early change in patient-reported symptoms within the PROMIS - Pain Interference - Short Form through Week 14 | Baseline to Week 14 | Change in PROMIS Pain Interference-SF from baseline to Week 14. |
| Secondary | To assess early change in patient-reported symptoms within the PROMIS - Fatigue - Short Form through Week 14 | Baseline to Week 14 | Change in PROMIS Fatigue-SF scores from baseline to Week 14. |
| Secondary | To assess early change in patient-reported symptoms within the PROMIS - Anxiety - Short Form through Week 14 | Baseline to Weeks 2, 6 and 14 | Change in PROMIS Anxiety-SF-scores from baseline to Weeks 2, 6, and 14. |
| Secondary | To assess early change in patient-reported symptoms within the PROMIS - Depression - Short Form through Week 14 | Baseline to Weeks 2, 6 and 14 | Change in PROMIS Depression- SF-scores from baseline to Weeks 2, 6, and 14. |
| Secondary | To assess early change in patient-reported symptoms within the PROMIS - Sleep Disturbance - Short Form through Week 14 | Baseline to Weeks 2, 6 and 14 | Change in PROMIS Sleep Disturbance- SF-scores from baseline to Weeks 2, 6, and 14. |
| Secondary | To assess early change in patient-reported symptoms within the PROMIS - Physical Function - Short Form through Week 14 | Baseline to Weeks 2, 6 and 14 | Change in PROMIS Physical Function- SF-scores from baseline to Weeks 2, 6, and 14. |
| Secondary | To assess early change in patient-reported symptoms within the PROMIS - Ability to Participate in Social Roles and Activities - Short Form through Week 14 | Baseline to Weeks 2, 6 and 14 | Change in PROMIS Ability to Participate in Social Roles and Activities- SF-scores from baseline to Weeks 2, 6, and 14. |
| Secondary | To evaluate the association between the PRO-2 and each PROMIS domain | Baseline to Weeks 14, 30, and 52 | Correlation between PRO-2 scores and each individual PROMIS domain T-score • Correlation between change in PRO-2 scores and change in each individual PROMIS domain T-score |
| Secondary | To assess the efficacy of therapy in resolving patient-reported symptoms by obtaining PRO-2 clinical remission, defined as a stool frequency score ≤ 3 and abdominal pain score ≤ 1 using unweighted subscores through week 52. | Baseline to Weeks 2, 6, 14, 22, 30, 38, 46, and 52 | PRO-2 improvement (defined as a stool frequency score defined as a stool frequency score ≤ 3 and abdominal pain score ≤ 1 using unweighted subscores and no worsening of stool frequency and/or abdominal pain scores from baseline ) |
| Secondary | To assess the efficacy of therapy in resolving patient-reported symptoms by obtaining PRO-2 clinical response, defined as a decrease in the weighted PRO-2 of ≥ 50% from baseline through week 52. | Baseline to Weeks 2, 6, 14, 22, 30, 38, 46, and 52 | PRO-2 enhanced clinical response defined as a decrease in the weighted PRO-2 of ≥ 50% from baseline through week 52 |
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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