Trial Profile
A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn's Disease
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 05 May 2021
Price :
$35
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At a glance
- Drugs Vedolizumab (Primary)
- Indications Crohn's disease; Ulcerative colitis
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms GEMINI-LTS
- Sponsors Takeda; Takeda Development Centre Europe; Takeda Oncology
- 28 Apr 2021 Results reporting immunogenicity rates from GEMINI LTS study using a new drug-tolerant ECL assay published in the Journal of Clinical Pharmacology
- 07 Mar 2021 This trial has been discontinued in Portugal (Global End Date: 31 Oct 2017), according to European Clinical Trials Database record.
- 02 Sep 2020 Results assessing the final safety outcomes along with exploratory clinical and HRQOL outcomes published in the Alimentary Pharmacology and Therapeutics