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Sponsors and Collaborators: |
EMD Serono ZymoGenetics |
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Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00642902 |
To evaluate the safety and tolerability of atacicept and to explore if atacicept reduces Central Nervous System inflammation in subjects with RMS as assessed by frequent MRI. This study is randomised. Study medication is administered via subcutaneous (under the skin) injections.
Condition | Intervention | Phase |
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Relapsing Multiple Sclerosis |
Drug: atacicept Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
Official Title: | A Randomised, Double-Blind, Placebo-Controlled, Multicentre Phase II Study to Evaluate the Safety, Tolerability and Efficacy as Assessed by Frequent MRI Measures of Three Doses of Atacicept Monotherapy in Subjects With Relapsing Multiple Sclerosis (RMS) |
Estimated Enrollment: | 292 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
High-dose treatment with Atacicept
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Drug: atacicept
Atacicept high, mid and low-dose, respectively
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2: Experimental
Mid-dose treatment with Atacicept
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Drug: atacicept
Atacicept high, mid and low-dose, respectively
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3: Experimental
Low dose treatment with Atacicept
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Drug: atacicept
Atacicept high, mid and low-dose, respectively
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4: Placebo Comparator
Placebo
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Drug: Placebo
Placebo will be supplied in a transparent, sterile solution for injection in pre-filled syringes matching the Atacicept pre-filled syringes, each containing 1mL. The placebo formulation to be used in this study contains trehalose and 10 mmol sodium acetate buffer (pH 5)."
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lynne Macgregor | +41 22 414 4752 | Lynne.Macgregor@merckserono.net |
Study Director: | Bruno Musch, MD, PhD | Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany |
Responsible Party: | Merck Serono International S.A. ( Lynne Macgregor ) |
Study ID Numbers: | 28063 |
Study First Received: | March 21, 2008 |
Last Updated: | July 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00642902 |
Health Authority: | United States: Food and Drug Administration |
Morphine Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases |
Demyelinating Autoimmune Diseases, CNS Demyelinating diseases Sclerosis Autoimmune Diseases of the Nervous System |
Pathologic Processes Immune System Diseases Nervous System Diseases |