Efficacy and Safety of Vatelizumab in Patients Who Completed Treatment
A Long-Term Follow-up Study Assessing the Safety and Efficacy of Vatelizumab in Multiple Sclerosis (MS) Patients Who Completed Treatment in Study DRI13839
What it found
The trial was stopped early because the treatment was not working.
Reason given: Study discontinued based on planned interim analysis of the primary endpoint. Not linked to any safety concern.
This trial finished 10 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Vatelizumab
Integrin alpha-2 antagonist
What it measured
Main measures
Proportion of patients experiencing adverse events
from Week 0 to Week 192
SafetyNumber of treatment-emergent adverse events
Safety
Other measures (3)
Change in total volume of T2 lesions
from Week 0 to Week 84
MRI lesionsChange in number of T1 hypointense lesions
from Week 0 to Week 84
MRI lesionsChange in total volume of T2 lesions and number of T1 hypointense lesions
MRI lesions
Who could take part
Relapsing MS · 18 and over
Show the full criteria
Inclusion criteria
Patients who completed the 12-week treatment period in DRI13839.
Exclusion criteria
* Any clinically significant or ongoing adverse events, or laboratory abnormalities from DRI13839 that per Investigator judgment would adversely affect the patient's participation in the long-term extension study. * Confirmed platelet count below the lower limit of normal at any time during DRI13839. * Pregnancy or breast-feeding. * Other protocol defined exclusion criteria may apply. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Primary Objective: To assess the long-term safety of vatelizumab in MS patients Secondary Objective: To assess the long-term efficacy of vatelizumab
Papers
Loading reviews and guidelines…
Related trials
- Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
Recruiting
Still running
- A Study Utilising Data From European Union (EU) National Multiple Scle
Running, not recruiting
Still running
- A Study of End of Dose Phenomena in Subcutaneous Natalizumab Treated M
Stopped early
Stopped
- A Study to Investigate the Radiological Onset of Action After Treatmen
Phase 4 · Stopped early
Stopped
- The 'Wearing Off' Effect of DMT
Completed
No results found
- A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacody
Phase 3 · Stopped early
Stopped: not working
History
Started
Feb 2015
Main results due
Apr 2016
Finished
Jul 2016