ONWARD Phase II Trial Will Assess Therapeutic Benefit of Oral Cladribine Added-on to New Formulation of Rebif(R) in Multiple Sclerosis Patients.
Merck Serono announced today that it has begun the ONWARD (Oral Cladribine Added ON To Rebif New Formulation in Patients With Active Relapsing Disease) Phase II study. The ONWARD study will evaluate the safety, tolerability and efficacy of two dose regimens of Merck Serono's proprietary oral formulation of cladribine when added to the new formulation of Rebif(R) (interferon beta-1a) in multiple sclerosis (MS) patients with active disease despite treatment with Rebif(R). Oral cladribine is currently also evaluated as a monotherapy in a fully enrolled Phase III pivotal trial (the CLARITY study) for first-line treatment of relapsing forms of MS. The new formulation of Rebif(R) is under regulatory review by the European Medicines Agency, the US Food and Drug Administration and other healthcare authorities.
"Multiple sclerosis patients with signs of active disease while on treatment with a disease modifying drug may benefit from adding another agent with a different mechanism of action, to complement and increase the overall efficacy while maintaining an acceptable safety and tolerability profile," said Bruno Musch, Merck Serono's Head of Neurology Clinical Development. "The different mechanism of action and the oral intermittent administration of oral cladribine make it a potentially useful add-on therapy to Rebif(R) at a critical time of disease progression."
"Oral cladribine is currently being evaluated as a monotherapy in the CLARITY Phase III pivotal study and is on track to become the first oral therapy for first-line treatment of multiple sclerosis", said Franck Latrille, Merck Serono's Head of Product Development. "We are now initiating the ONWARD study as we believe that oral cladribine also has a great potential as an add-on therapy, for patients who have signs of active relapsing disease while on a treatment."
The ONWARD study is a two-year (96 weeks), randomised, double-blind, placebo-controlled, international trial. The trial will be conducted in 40 sites located in the United States and in Europe. It will involve 260 MS patients who have experienced at least one relapse while taking Rebif(R) during the year prior to study enrollment. Study participants will be randomised in one of the three arms of the study to receive one of two different dose regimens of oral cladribine or matching placebo tablets, in addition to the new formulation of Rebif(R) 44 micrograms subcutaneous three times a week. In the study, oral cladribine is given in two or four treatment cycles in the first year, with each cycle consisting of daily administration for four or five consecutive days, which means study patients take oral cladribine therapy for only 8 to 20 days during that year. In the second year, two treatment cycles are administered in all dose regimens.
The primary safety endpoints of the ONWARD study consist of a wide range of safety and tolerability parameters measured during 96 weeks of treatment. The primary efficacy endpoint is the mean change in the number of new T1 gadolinium-enhanced lesions per subject per magnetic resonance imaging (MRI) scan from baseline to 96 weeks.
About oral cladribine
Merck Serono's proprietary oral formulation of cladribine is currently being evaluated in Phase III as a treatment for patients with relapsing forms of multiple sclerosis (MS). Cladribine is a small molecule that interferes with the behaviour and the proliferation of certain white blood cells, particularly lymphocytes, which are involved in the pathological process of MS. Through its differentiated mechanism of action, oral cladribine may offer a safe and effective new option to patients with MS.
SOURCE Serono International S A (24/01/07)
Do you think we need to advise them that some people are interested in EDSS scores and disease progression, brain atrophy, etc.? I can't believe that's not part of the study.The primary efficacy endpoint is the mean change in the number of new T1 gadolinium-enhanced lesions per subject per magnetic resonance imaging (MRI) scan from baseline to 96 weeks.
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