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NCT00879658 · ClinicalTrials.gov registry record · Phase 2

Safety, Tolerability, Efficacy and Optimal Dose Finding Study of BAF312 in Patients With Relapsing-remitting Multiple Sclerosis

A Phase 2 study of Relapsing Remitting Multiple Sclerosis, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
297
Enrollment target
20
Study locations

NCT00879658 is a Phase 2 study of Relapsing Remitting Multiple Sclerosis that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 297 participants, above the 191-participant average among 25 other Relapsing Remitting Multiple Sclerosis trials with a reported enrollment target (55% higher). The trial reports 20 study locations across 15 states.

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The verdict

NCT00879658, a Phase 2 study of Relapsing Remitting Multiple Sclerosis, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
297 participants
Enrollment target
20
Study locations

Study Summary

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).

Conditions Studied

Relapsing Remitting Multiple Sclerosis

Interventions

  • DRUG Placebo
  • DRUG BAF312

Study Locations (20)

Florida

  • Novartis Investigative Site - Miami
  • Novartis Investigative Site - Pompano Beach
  • Novartis Investigative Site - Tallahassee
  • Novartis Investigative Site - Tampa

Illinois

  • Novartis Investigative Site - Chicago
  • Novartis Investigative Site - Elk Grove Village

Quebec

  • Novartis Investigative Site - Gatineau
  • Novartis Investigative Site - Greenfield Park

Alabama

  • Novartis Investigative Site - Cullman

California

  • Novartis Investigative Site - San Francisco

Colorado

  • Novartis Investigative Site - Centennial

Michigan

  • Novartis Investigative Site - Grand Rapids

North Carolina

  • Novartis Investigative Site - Raleigh

Trial Details

FieldValue
Enrollment Target 297 participants
Start Date 2009-03-30
Est. Completion 2011-05-04
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00879658

The ClinicalTrials.gov registry entry for NCT00879658 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 297 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 191-participant average among 25 other Relapsing Remitting Multiple Sclerosis trials with a reported enrollment target (55% higher). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Relapsing Remitting Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00879658 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Florida, Illinois, Quebec.

Frequently Asked Questions

What is clinical trial NCT00879658 about?

NCT00879658 is a clinical study titled "Safety, Tolerability, Efficacy and Optimal Dose Finding Study of BAF312 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 stud...

What is the current status of trial NCT00879658?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 297 participants. The study started on 2009-03-30. Estimated completion is 2011-05-04.

What conditions does trial NCT00879658 study?

This clinical trial studies the following conditions: Relapsing Remitting Multiple Sclerosis.

What interventions are being tested in trial NCT00879658?

The interventions under investigation include: Placebo (DRUG), BAF312 (DRUG).

Who is sponsoring clinical trial NCT00879658?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00879658 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.