Relapsing-remitting Multiple Sclerosis Clinical Trial
Official title:
A Phase II, Double-blind, Randomized, Multi-center, Adaptive Dose-ranging, Placebo-controlled, Parallel-group Study Evaluating Safety, Tolerability and Efficacy on MRI Lesion Parameters and Determining the Dose Response Curve of BAF312 Given Orally Once Daily in Patients With Relapsing-remitting Multiple Sclerosis.
The purpose of this study was to determine the dose-response curve for the MRI-based efficacy
of BAF312 compared with placebo in patients with Relapsing-Remitting Multiple Sclerosis
(RRMS), and to characterize its safety and tolerability for the selection of an optimal dose
in a later phase III study.
Study Design Rationale An adaptive design was chosen to characterize the dose response curve
of BAF312. In a first period of study ("Period 1"), three doses of BAF312 and placebo were
tested for MRI efficacy. Based on an interim analysis (IA) after 3 months of treatment, two
additional active doses for period 2 wereselected , thus allowing to optimize the overall
determination of the dose response curve with 5 data points of active treatment, and placebo.
The doses were kept blinded. The use of Modeling and Simulation allowed to establish the full
range and dynamics of the dose-response curve in silico, and hence the definition of the
optimal dose for later phase III studies.
The choice of placebo as treatment control was essential to obtain information on the
specific compared to non-specific effects of active treatment and provides the best way of
evaluating the efficacy and of assessing the true safety and tolerability profile of BAF312.
Short-term placebo exposure (6 (Period 1) or 3 (Period 2) months, respectively) was unlikely
to lead to longer term differences in outcomes [Polman, 2008]. The use of an adaptive design
strategy contributed to a significant reduction of placebo exposure, both in terms of the
number of patients and duration, as compared to conventional trial models.
Patients having completed the study within the protocol might be eligible for the Extension
Phase study where they receive long-term BAF312 treatment (a separate protocol).
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02549703 -
Mitochondrial Dysfunction and Disease Progression
|
||
| Completed |
NCT02293967 -
Mass Balance Study of MT-1303
|
Phase 1 | |
| Terminated |
NCT02222948 -
Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis
|
Phase 2 | |
| Terminated |
NCT01790269 -
Monitoring Natural Killer Cells in Multiple Sclerosis Patients Treated With Fingolimod
|
||
| Terminated |
NCT01701856 -
Natalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis
|
Phase 4 | |
| Completed |
NCT00525668 -
Sunphenon Epigallocatechin-gallate (EGCg) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)
|
Phase 1/Phase 2 | |
| Terminated |
NCT00398528 -
An fMRI Study of Treatment Optimization Comparing Two Disease Modifying Therapies Used to Treat Relapsing Remitting Multiple Sclerosis
|
Phase 4 | |
| Completed |
NCT00315367 -
A fMRI(Functional Magnetic Resonance Imaging) Research Study to Learn More About Multiple Sclerosis and Individuals Potentially Experiencing Memory Difficulties
|
Phase 4 | |
| Terminated |
NCT04032171 -
Study of Evobrutinib in Participants With RMS
|
Phase 3 | |
| Completed |
NCT01930708 -
A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes
|
Phase 4 | |
| Completed |
NCT03000647 -
Guided Versus Non-guided Pelvic Floor Exercises for Urinary Incontinence in Relapsing-Remitting Multiple Sclerosis
|
N/A | |
| Completed |
NCT02205489 -
Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADA
|
Phase 4 | |
| Completed |
NCT02753088 -
Efficacy and Safety of BCD-063 and Copaxone-Teva in Patients With Relapsing-Remitting Multiple Sclerosis
|
Phase 3 | |
| Recruiting |
NCT01466114 -
Estriol Treatment in Multiple Sclerosis (MS): Effect on Cognition
|
Phase 2 | |
| Completed |
NCT01244139 -
Safety Study of BIIB033 in Subjects With Multiple Sclerosis
|
Phase 1 | |
| Completed |
NCT01416155 -
Extension Study to Evaluate Safety and Efficacy of Natalizumab in Japanese Participants With Relapsing-Remitting Multiple Sclerosis
|
Phase 2 | |
| Completed |
NCT00559702 -
Safety Study of Natalizumab to Treat Multiple Sclerosis (MS)
|
Phase 1 | |
| Completed |
NCT00493116 -
Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon Beta
|
Phase 4 | |
| Terminated |
NCT01706107 -
Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants
|
||
| Completed |
NCT01943526 -
Ireland Natalizumab (TYSABRI) Observational Program
|