Trial · NCT05928039
PATHFINDER: Evaluating the Optimal First-Line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn's Disease
NCT05928039, Phase 4, Recruiting, University of Calgary
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PATHFINDER: Evaluating the Optimal First-Line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn's Disease. Trials, record NCT05928039. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05928039
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PATHFINDER: Evaluating the Optimal First-Line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn's Disease
- NCT number
- NCT05928039
- Status
- Recruiting
- Phases
- Phase 4
- Enrollment
- 210 participants, estimated
- Lead sponsor
- University of Calgary
- Conditions
- Crohn Disease
- Interventions
TNFa Antagonist - Infliximab, TNFa Antagonist - Adalimumab, Anti-IL12/23 or anti-IL23 - Ustekinumab, Anti-IL12/23 or anti-IL23 - Risankizumab, Anti-integrin - Vedolizumab IV, Anti-integrin - Vedolizumab IV and SC
- First posted
- 2023-07-03
- Last updated
- 2026-10-26
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Corticosteroid-free endoscopic remission | 1 year | SES-CD ≤4, ileal segment SES-CD ≤2, and no ulcers in any segment \>5 mm, off corticosteroids for ≥ 16 weeks |
| Secondary | CD-related complications | 1 year | Composite of disease flare, obstruction, new fistula/abscess, CD-related hospitalization, CD-related surgery |
| Secondary | Time to first Crohn's disease-related complication. | From date of randomization until the date of first documented Crohn's disease-related complication or date of death from any cause, whichever came first, assessed up to 12 months | Composite of disease flare, obstruction, new fistula/abscess, CD-related hospitalization, CD-related surgery |
| Secondary | Biomarker remission | Months 4, 8, and 12 | C-reactive protein (CRP) \<5 mg/L and fecal calprotectin \<250 µg/g, assessed in participants with elevated biomarkers at baseline |
| Secondary | Corticosteroid-free clinical remission | Months 4, 8, and 12 | Harvey Bradshaw Index \[HBI\] ≤4 without exposure to systemic corticosteroids for ≥16 weeks prior to assessment |
| Secondary | Treatment persistence | 1 year | Duration of time from first biologic dose to discontinuation, the proportion of participants requiring a class switch, and the proportion of participants requiring dose optimization of biologic treatment or addition of rescue immunomodulators |
| Secondary | Health-related quality of life after first-line biologic treatment | 1 year | Quality of life at 1-year measured using EuroQol 5D (range 0 \[worst imaginable health state\] to 100 \[best imaginable health state\]) |
| Secondary | Safety of first-line biologic treatment | 1 year | Unexpected AEs, severe AEs, drug and procedure-related AEs, any serious AEs (SAEs), any AEs leading to biologic discontinuation |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40357993 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05928039
GET https://conductscience.org/api/trials/v1/NCT05928039/registered