Last reviewed · How we verify
NCT05158517: DOPER
VeDOlizumab PERsistence in IBD Patients After Switching From Intravenous to Subcutaneous Administration : a Real-life Multicenter Study (DOPER)
trial testing Subcutaneous vedolizumab in Inflammatory Bowel Diseases in 349 participants. Participants enrolled and being followed up; not accepting new ones.
31 March 2024
Quick facts
| Lead sponsor | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 349 |
| Start date | 20 March 2022 |
| Primary completion | 31 March 2024 |
| Estimated completion | 20 March 2025 |
| Sites | 1 location across France |
Drugs / interventions tested
- Subcutaneous vedolizumab — full drug profile →
Conditions studied
- Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives — full company profile →
Who can join
Adults 18 to 75, any sex, with Inflammatory Bowel Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Descriptive : A 12-months multicenter, observational, prospective cohort study. Population : IBD patients under stable clinical and biological remission will be proposed to switch from the IV vedolizumab to the SC vedolizumab as part of routine care. All consecutive IBD patients in IBD centers participating in the study will be proposed to participate in the study during their regular outpatients' visits. Objectives : The primary objective of DOPER study is to describe SC vedolizumab persistence after switching from IV vedolizumab to SC vedolizumab at month 12.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05158517
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Inflammatory Bowel Diseases
Currently open trials in the same condition.
- NCT07520747 — A Database Study of Disease, Treatment Patterns and Healthcare Use in Children With Inflammatory Bowel Diseases in Korea · recruiting
- NCT07349472 — Pentoxifylline in Patients With Ulcerative Colitis · Phase 2 · recruiting
- NCT07033208 — Feasibility of a Wireless Thermal Capsule Endoscopy to Detect Gastrointestinal Thermal Variance · NA · recruiting
- NCT06842316 — Effects of Phytocannabinoids on Immune Response and Autophagy During Chronic Immune-mediated Inflammatory Diseases · recruiting
- NCT06453317 — Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis · Phase 2 · recruiting
Other Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives trials
Trials by the same sponsor.
- NCT06742385 — Evaluation of a Remote Monitoring Application in the Follow-up of Patients With Active Inflammatory Bowel Diseases · NA · recruiting
- NCT06250361 — Identification of Factors ASsociaTed With a Delayed Diagnosis in Crohn's Disease · unknown
- NCT06089590 — Ibd CAncer and seRious Infections in France (I-CARE 2) · recruiting
- NCT05072782 — Management of Moderate POstoperative Recurrence in Crohn's Disease: a randoMizEd contROLled Trial of Therapeutic Escalat · Phase 4 · unknown
- NCT04990258 — A 24-month Real Life PErsistence Efficacy and Safety Study in IBD Patients in REMission Switched From Intravenous Inflix · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05158517 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Last refreshed: 22 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05158517.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing