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NCT03135249 · ClinicalTrials.gov registry record · Phase 4
Sequential Natalizumab - Alemtuzumab Therapy in Patients With Relapsing Forms of Multiple Sclerosis
A Phase 4 study of Multiple Sclerosis, MS, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 9
- Enrollment target
- 2
- Study locations
NCT03135249: Completed Phase 4 study of Multiple Sclerosis, MS, sponsored by University of Texas Southwestern Medical Center.
NCT03135249 is a Phase 4 study of Multiple Sclerosis, MS that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 9 participants, below the 66-participant average among 7 other Multiple Sclerosis, MS trials with a reported enrollment target (86% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03135249, a Phase 4 study of Multiple Sclerosis, MS, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 9 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to determine if a sequential combination therapy of natalizumab and alemtuzumab induces peripheral tolerance and reduces the annualized relapse rate (ARR) in patients with relapsing-remitting multiple sclerosis (RRMS).
Primary Outcome
The goal of this trial is to establish a disease-free state over a 24 months period in patients who received the natalizumab-alemtuzumab sequential therapy. ARR was the number of confirmed relapses in a year, calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of time in study.
Conditions Studied
Interventions
- DRUG Alemtuzumab
Study Locations (2)
Texas
- VA North Texas Health Care System - Dallas
- UT Southwestern Medical center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2018-05-01 |
| Est. Completion | 2020-11-04 |
| Phase | Phase 4 |
What the finished NCT03135249 record still lists
NCT03135249 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 66-participant average among 7 other Multiple Sclerosis, MS trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Multiple Sclerosis, MS appearing as the primary indexed condition, and to 1 intervention - of which Alemtuzumab is the first listed.
NCT03135249 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03135249 about?
NCT03135249 is a clinical study titled "Sequential Natalizumab - Alemtuzumab Therapy in Patients With Relapsing Forms of Multiple Sclerosis". The purpose of this study is to determine if a sequential combination therapy of natalizumab and alemtuzumab induces peripheral tolerance and reduces the annualized relapse rate (ARR) in patients with relapsing-remitting multiple sclerosis (RRMS).
What is the current status of trial NCT03135249?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 9 participants. The study started on 2018-05-01. Estimated completion is 2020-11-04.
What conditions does trial NCT03135249 study?
This clinical trial studies the following conditions: Multiple Sclerosis, MS.
What interventions are being tested in trial NCT03135249?
The interventions under investigation include: Alemtuzumab (DRUG).
Who is sponsoring clinical trial NCT03135249?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03135249 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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