Press Release
Two-Year Results From CLARITY Study With Cladribine Tablets in Multiple Sclerosis Published in The New England Journal of Medicine
Merck SeronoPosted on:21 Jan 10GENEVA, Switzerland, January 21 /PRNewswire/ -- Merck Serono, a division of Merck KGaA, Darmstadt, Germany,announced today the online publication of the results from the CLARITY(1)Phase III trial using Cladribine Tablets (Merck Serono's proprietaryinvestigational oral formulation of cladribine) in The New England Journal ofMedicine(2). The CLARITY study was a two-year (96-week), randomized,double-blind, placebo-controlled Phase III trial of Cladribine Tablets in1,326 people with relapsing-remitting multiple sclerosis (MS).
"The CLARITY trial represents an important step forward inmultiple sclerosis research, and we are pleased that the results have beenpublished in The New England Journal of Medicine," says Dr.
The authors report in the publication that the primary endpoint and key secondary end points of the CLARITY trial were met. The CLARITYdata were presented at the 61st Annual Meeting of the American Academy ofNeurology (AAN) in April 2009 and at other international scientific meetings.
CLARITY study design
The CLARITY study was a two-year (96-week), randomized,double-blind, placebo-controlled, international trial. It randomized 1,326patients with relapsing-remitting MS according to the revised McDonaldcriteria. Study participants were randomized to one of three differenttreatment groups consisting of two different dose regimens of CladribineTablets or matching placebo tablets (1:1:1 ratio). Cladribine Tablets weregiven in two (3.5 mg/kg total dose) or four (5.25 mg/kg total dose) treatmentcourses in the first year, with each course consisting of once dailyadministration for four to five consecutive days (depending on patientweight), which means study patients took Cladribine Tablets for 8 to 20 daysduring the year. In the second year, two treatment courses were administeredto all patient groups, meaning that patients took Cladribine Tablets for 8 to10 days during the year.
The primary endpoint of the CLARITY study was the relapse rateover 96 weeks. Secondary endpoints included MRI endpoints, proportion ofsubjects relapse-free and disability progression at 96 weeks.
About Cladribine Tablets
Merck Serono's oral formulation of cladribine (CladribineTablets) is an investigational treatment for patients with relapsing forms ofmultiple sclerosis (MS). Cladribine is a small molecule that may interferewith the behavior and the proliferation of certain white blood cells,particularly lymphocytes, which are thought to be involved in thepathological process of MS.
The clinical development program for Cladribine Tabletsincludes:
- The CLARITY (CLAdRIbine Tablets Treating MS OrallY) studyand its extension: a two-year Phase III placebo-controlled trial designed to evaluate the efficacy and safety of Cladribine Tablets as a monotherapy in patients with relapsing-remitting MS and its two-year extension designed to provide data on the long-term safety and efficacy of extended administration of Cladribine Tablets for up to four years. - The ORACLE MS (ORAl CLadribine in Early MS) study: atwo-year Phase III placebo-controlled trial designed to evaluate the efficacy and safety of Cladribine Tablets as a monotherapy in patients at risk of developing MS (patients who have experienced a first clinical event suggestive of MS). This trial was announced in September 2008. - The ONWARD (Oral Cladribine Added ON To Interferon beta-1ain Patients With Active Relapsing Disease) study: a Phase IIplacebo-controlled trial designed primarily to evaluate the safety andtolerability of adding Cladribine Tablets treatment to patients withrelapsing forms of MS, who have experienced breakthrough disease while on established interferon-beta therapy. This trial was announced inJanuary 2007.
About multiple sclerosis
Multiple sclerosis (MS) is a chronic, inflammatory conditionof the central nervous system and is the most common, non-traumatic,disabling neurological disease in young adults. It is estimated that morethan two million people have MS worldwide. While symptoms can vary, the mostcommon symptoms of MS include blurred vision, numbness or tingling in thelimbs and problems with strength and coordination. The relapsing forms of MSare the most common.
About Merck Serono
Merck Serono is the division for innovative prescriptionpharmaceuticals of Merck KGaA, Darmstadt, Germany, a global pharmaceuticaland chemical company. Headquartered in Geneva, Switzerland, Merck Seronodiscovers, develops, manufactures and markets innovative small molecules andbiopharmaceuticals to help patients with unmet medical needs. In the UnitedStates and Canada, EMD Serono operates through separately incorporatedaffiliates.
Merck Serono has leading brands serving patients with cancer (Erbitux(R),cetuximab), multiple sclerosis (Rebif(R), interferon beta-1a), infertility(Gonal-f(R), follitropin alpha), endocrine and metabolic disorders (Saizen(R)and Serostim(R), somatropin), (Kuvan(R), sapropterin dihydrochloride) as wellas cardiometabolic diseases (Glucophage(R), metformin), (Concor(R),bisoprolol), (Euthyrox(R), levothyroxine). Not all products are available inall markets.
With an annual R&D expenditure of around EUR 1bn, Merck Seronois committed to growing its business in specialist-focused therapeutic areasincluding neurodegenerative diseases, oncology, fertility and endocrinology,as well as new areas potentially arising out of research and development inautoimmune and inflammatory diseases.
About Merck
Merck is a global pharmaceutical and chemical company withtotal revenues of EUR 7.6 billion in 2008, a history that began in 1668, anda future shaped by approximately 33,000 employees in 60 countries. Itssuccess is characterized by innovations from entrepreneurial employees.Merck's operating activities come under the umbrella of Merck KGaA, in whichthe Merck family holds an approximately 70% interest and free shareholdersown the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co.was expropriated and has been an independent company ever since.
(1) CLARITY: CLAdRIbine Tablets Treating MS OrallY
(2) Giovannoni G et al. A placebo-Controlled Trial of Oral Cladribine forRelapsing Multiple Sclerosis; available on www.nejm.org; will also bepublished in the February 4, 2010 printed issue of The New England Journal ofMedicine
For more information, please visit http://www.merckserono.comor http://www.merck.de
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