Atacicept in Multiple Sclerosis, Phase II
This study has been terminated.
(EMD Serono voluntarily decided to terminate this trial after observing increased MS disease activity in the atacicept treatment groups compared to placebo)
Sponsor:
EMD Serono
Information provided by:
EMD Serono
ClinicalTrials.gov Identifier:
NCT00642902
First received: March 21, 2008
Last updated: April 22, 2011
Last verified: April 2011
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Purpose
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 |
|---|---|---|
|
Relapsing Multiple Sclerosis |
Drug: atacicept Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
Further study details as provided by EMD Serono:
Primary Outcome Measures:
- Mean number of T1 gadolinium (Gd)-enhancing lesions per subject per scan. [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of new T1 hypointense lesions, Proportion of subjects free from relapses during the 36-week treatment period, Nature, severity, and incidence of adverse events and infections [ Time Frame: weeks 12, 24, 36 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 292 |
| Study Start Date: | March 2008 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
High-dose treatment with Atacicept
|
Drug: atacicept
Atacicept high, mid and low-dose, respectively
|
|
Experimental: 2
Mid-dose treatment with Atacicept
|
Drug: atacicept
Atacicept high, mid and low-dose, respectively
|
|
Experimental: 3
Low dose treatment with Atacicept
|
Drug: atacicept
Atacicept high, mid and low-dose, respectively
|
|
Placebo Comparator: 4
Placebo
|
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)."
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of Relapsing Multiple Sclerosis (per McDonald criteria, 2005);
Exclusion Criteria:
- Have primary progressive MS.
- Have secondary progressive MS without superimposed relapses.
- Relevant cardiac, hepatic and renal diseases
- Pre treatment with immunosuppressants and immunomodulating drugs
- Clinical significant abnormalities in blood cell counts and Ig levels
- Clinical significant acute or chronic infections.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00642902
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| United States, Arizona | |
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| Phoenix, Arizona, United States | |
| United States, Georgia | |
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| Atlanta, Georgia, United States | |
| United States, Illinois | |
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| Northbrook, Illinois, United States | |
| United States, Michigan | |
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| East Lansing, Michigan, United States | |
| United States, New Hampshire | |
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| Dartmouth, New Hampshire, United States | |
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| Cleveland, Ohio, United States | |
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| Philadelphia, Pennsylvania, United States | |
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| Nashville, Tennessee, United States | |
| Australia | |
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| Box Hill, Australia | |
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| Fitzroy, Australia | |
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| New Lambton, Australia | |
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| Woodville, Australia | |
| Austria | |
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| Innsbruck, Austria | |
| Belgium | |
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| Diepenbeek, Belgium | |
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| Sijsele, Belgium | |
| Canada, Alberta | |
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| Calgary, Alberta, Canada | |
| Canada, Ontario | |
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| Ottawa, Ontario, Canada | |
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| Brno, Czech Republic | |
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| Hradec Kralove, Czech Republic | |
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| Olomouc, Czech Republic | |
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| Caen, France | |
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| Saint-Herblain, France | |
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| Bochum, Germany | |
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| Dusseldorf, Germany | |
| Lebanon | |
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| Beirut, Lebanon | |
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| Beyrouth, Lebanon | |
| Lithuania | |
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| Kaunas, Lithuania | |
| Netherlands | |
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| Breda, Netherlands | |
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| Nieuwegein, Netherlands | |
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| Rotterdam, Netherlands | |
| Russian Federation | |
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| Dnipropetrovsk, Russian Federation | |
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| Ekaterinburg, Russian Federation | |
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| Moscow, Russian Federation | |
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| Novosibirsk, Russian Federation | |
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| Saint Petersburg, Russian Federation | |
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| Samara, Russian Federation | |
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| Vladimir, Russian Federation | |
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| Yaroslavl, Russian Federation | |
| Spain | |
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| Barcelona, Spain | |
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| Madrid, Spain | |
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| Malaga, Spain | |
| Sweden | |
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| Stockholm, Sweden | |
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| Basel, Switzerland | |
| Ukraine | |
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| Kharkiv, Ukraine | |
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| Kyiv, Ukraine | |
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| Odessa, Ukraine | |
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| Uzhgorod, Ukraine | |
| United Kingdom | |
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| London, United Kingdom | |
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| Sheffield, United Kingdom | |
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| Stoke on Trent, United Kingdom | |
Sponsors and Collaborators
EMD Serono
Investigators
| Study Director: | Dan Mikol, MD, PhD | EMD Serono |
More Information
Additional Information:
No publications provided
| Responsible Party: | Lynne Macgregor, Merck Serono S.A. - Geneva an Affiliate of Merck KGaA Darmstadt, Germany |
| ClinicalTrials.gov Identifier: | NCT00642902 History of Changes |
| Other Study ID Numbers: | 28063 |
| Study First Received: | March 21, 2008 |
| Last Updated: | April 22, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013