Safety, Tolerability, Efficacy and Optimal Dose Finding Study of BAF312 in Patients With Relapsing-remitting Multiple Sclerosis
NCT ID: NCT00879658
Last Updated: 2020-01-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
297 participants
INTERVENTIONAL
2009-03-30
2011-05-04
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BAF312 10mg (period 1)
BAF312
BAF312 2 mg (period 1)
BAF312
BAF312 0.5 mg (period 1)
BAF312
BAF312 dose between 0.1 to 8 mg period 2
BAF312
BAF312 dose between 0.1 - 8 mg period 2
BAF312
Placebo (period 1, 2)
Placebo
Interventions
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BAF312
Placebo
Eligibility Criteria
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Inclusion Criteria
* A relapsing-remitting course of disease with at least 1 documented relapse during the previous year, or 2 documented relapses during the previous 2 years, or a positive gadolinium (Gd)-enhanced MRI scan at screening (in case the first MRI scan obtained at screening is negative, a second scan may be obtained 1 month later.)
* An Expanded Disability Status Scale (EDSS) score of 0-5.0 inclusive at randomization.
* Neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days prior to randomization.
* Patients who decline initiation or continuation of treatment with available disease modifying drugs for MS, for whatever reason, after having been informed about their respective benefits and possible adverse events by the investigator.
Exclusion Criteria
* History of chronic disease of the immune system other than MS
* Malignancies, diabetes, significant cardiovascular, pulmonary and hepatic diseases and conditions
* Active infections
18 Years
55 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Cullman, Alabama, United States
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San Francisco, California, United States
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Centennial, Colorado, United States
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Miami, Florida, United States
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Pompano Beach, Florida, United States
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Tallahassee, Florida, United States
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Tampa, Florida, United States
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Chicago, Illinois, United States
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Elk Grove Village, Illinois, United States
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Grand Rapids, Michigan, United States
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Raleigh, North Carolina, United States
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Akron, Ohio, United States
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Pittsburgh, Pennsylvania, United States
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Greenville, South Carolina, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Vancouver, British Columbia, Canada
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Ottawa, Ontario, Canada
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Gatineau, Quebec, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Helsinki, , Finland
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Tampere, , Finland
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Turku, , Finland
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Berlin, , Germany
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Berlin, , Germany
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Dresden, , Germany
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Freiburg im Breisgau, , Germany
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Leipzig, , Germany
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Lengerich, , Germany
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München, , Germany
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Münster, , Germany
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Wiesbaden, , Germany
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Veszprém, , Hungary
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Montichiari, BS, Italy
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Chieti, CH, Italy
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Milan, MI, Italy
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Roma, RM, Italy
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Roma, RM, Italy
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Roma, RM, Italy
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Bergen, , Norway
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Drammen, , Norway
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Oslo, , Norway
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Lodz, , Poland
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Lublin, , Poland
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Warsaw, , Poland
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Kazan', , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Seville, Andalusia, Spain
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Bilbao, Basque Country, Spain
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Barcelona, Catalonia, Spain
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Valencia, Valencia, Spain
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Madrid, , Spain
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Basel, , Switzerland
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Bern, , Switzerland
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Lugano, , Switzerland
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Zurich, , Switzerland
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Ankara, , Turkey (Türkiye)
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Haseki / Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Kocaeli, , Turkey (Türkiye)
Countries
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References
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Mercier F, Bornkamp B, Ohlssen D, Wallstroem E. Characterization of dose-response for count data using a generalized MCP-Mod approach in an adaptive dose-ranging trial. Pharm Stat. 2015 Jul-Aug;14(4):359-67. doi: 10.1002/pst.1693. Epub 2015 Jun 17.
Selmaj K, Li DK, Hartung HP, Hemmer B, Kappos L, Freedman MS, Stuve O, Rieckmann P, Montalban X, Ziemssen T, Auberson LZ, Pohlmann H, Mercier F, Dahlke F, Wallstrom E. Siponimod for patients with relapsing-remitting multiple sclerosis (BOLD): an adaptive, dose-ranging, randomised, phase 2 study. Lancet Neurol. 2013 Aug;12(8):756-67. doi: 10.1016/S1474-4422(13)70102-9. Epub 2013 Jun 11.
Other Identifiers
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2008-008719-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CBAF312A2201
Identifier Type: -
Identifier Source: org_study_id
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