Clinical trial · Observational
A Study to Observe Vedolizumab and Anti-tumour Necrosis Factors (Anti-TNFs) Outcomes in Real-world Biologic Ulcerative Colitis (UC) and Crohn's Disease (CD) Participants
Vedolizumab and Anti-TNFs Outcomes in Real-World Biologic Ulcerative Colitis and Crohn's Disease Patients
NCT03710486CI-TRIAL-00077610EVOLVE-IBERIAcompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to describe treatment patterns associated with first-line and second line biologic use (vedolizumab or other biologic) and to describe the real-world clinical effectiveness of the use (first-line and second line) vedolizumab versus other biologics at least 6 months post-treatment initiation.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colitis, Ulcerative | — | UNRESOLVED | — |
| Crohn Disease | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1: Vedolizumab
- description
- Participants diagnosed with UC or CD, who have initiated vedolizumab treatment between January 2017 until date of site initiation from the 25 participating sites will be observed from the date of UC or CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date is defined as the date when vedolizumab treatment was initiated.
- label
- Cohort 2: Other Biologic
- description
- Participants diagnosed with UC or CD, who have initiated other biologic treatment (infliximab, adalimumab, or golimumab \[UC only\]) between January 2017 until date of site initiation from the 25 participating sites will be observed from the date of UC or CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date is defined as the date when other biologic treatment was initiated.
Primary outcomes (30)
- measure
- Percentage of Participants With One or More Treatment Intensifications for CD Participants
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Has a diagnosis of moderate to severe UC or CD documented in the medical chart. 2. Received at least one dose of vedolizumab or other biologic (infliximab, adalimumab, or golimumab \[UC only\]) during the eligibility period. 3. Received the biologic treatment as first-line or second line biologic for UC or CD. 4. Has a minimum of six months of follow-up between date of starting biologic therapy (index event) and the date of completion of the participant pre-selection registry. Exclusion Criteria: 1. Received vedolizumab or another biologic as part of an interventional clinical trial ever in their lifetime (includes index treatment). 2. Index treatment was another biologic therapy other than vedolizumab, infliximab, adalimumab, or golimumab (UC only). 3. Initiated index treatment as combination therapy with two biologic agents. 4. The biologic was prescribed for treatment of perianal disease. 5. Received biologic therapy before the index period for a disease other than inflammatory bowel disease. 6. Medical chart is unavailable.
References
Publications (1)
- DERIVEDYarur A, Mantzaris GJ, Wang S, Adsul S, Kamble P, Cook E, Sajeev G, Guerin A, Bressler B. Stratified Patient Profiling for Vedolizumab Effectiveness in Crohn's Disease: Identifying Optimal Subgroups for Enhanced Treatment Response in the EVOLVE Study. Adv Ther. 2024 Jun;41(6):2324-2341. doi: 10.1007/s12325-024-02825-w. Epub 2024 Apr 24. PMID 38658485