REbif FLEXible Dosing in Early Multiple Sclerosis (MS)

Condition(s) targeted: Multiple Sclerosis

Intervention: Rebif New Formulation (RNF) (Drug); Rebif New Formulation (RNF) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: EMD Serono

Official(s) and/or principal investigator(s):
Bettina M. Stubinski, MD, Study Director, Affiliation: Merck Serono S.A. - Geneva

Overall contact:
Local Medical Information Office - Geneva, Switzerland, Phone: +41-41-747-0812

The primary objective of the study is to evaluate the effect of Rebif New Formulation 44 mcg (tiw and ow) versus placebo on the time to conversion to McDonald MS in patients with a first clinical demyelinating event at high risk of converting to MS

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial of Rebif New Formulation (44 Mcg Tiw and 44 Mcg ow) in Subjects at High Risk of Converting to Multiple Sclerosis

Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Time to conversion to MS according to the revised McDonald criteria (2005)

Secondary outcome: Time from randomisation to conversion to CDMS defined by either a 2nd attack or a sustained increase (greater than or equal to 1.5 points) in the EDSS score

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subject with a single, first clinical event suggestive of MS within the last 60 days

(clock starts 24 hours after onset). The event must be a new neurological abnormality present for at least 24 hours,either mono- or polysymptomatic, other than a paresthesia, vegetative or cerebral dysfunction;

- Subject has at least two clinically silent lesions on the T2-weighted MRI scan, with a

size of at least 3 mm, at least one of which is ovoid or periventricular or infratentorial;

- EDSS 0 - 5. 0 at at least one time point during the screening period before start of

treatment

- Subject is between 18 and 50 years old, inclusive;

- Subject is willing to follow study procedures;

- Subject has given written informed consent;

- If female, subject must:

- be neither pregnant nor breast-feeding nor attempting to conceive

- use a highly effective method of contraception. A highly effective method of

contraception is defined as those which result in a low failure rate (i. e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.

Exclusion Criteria:

- Subject has a diagnosis of Multiple Sclerosis (per McDonald criteria 2005);

- Subject has any other disease that could better explain the patient's signs and

symptoms;

- Subject has complete transverse myelitis or bilateral optic neuritis;

- Subject uses or has used any other approved MS DMD;

- Subject has used any investigational drug or undergone an experimental procedure

within 12 weeks of visit 1;

- Subject received oral or systemic corticosteroids or ACTH within 30 days of visit 1;

- Subject has total bilirubin > 2. 5x upper limit of normal,

- Subject has total aspartate aminotransferase (AST) or alanine aminotransferase (ALT)

or alkaline phosphatase > 2. 5 times the upper limit of normal values;

- Subject has inadequate bone marrow reserve, defined as a total white blood cell count

< 3. 0 x 109/L, platelet count < 75 x 109/L, haemoglobin < 100 g/L.

- Subject suffers from current autoimmune disease;

- Subject suffers from major medical or psychiatric illness (including history of severe

depressive disorders and/or suicidal ideation) that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol;

- Subject has a history of seizures not adequately controlled by treatment;

- Subject has cardiac disease, such as angina, congestive heart failure or arrhythmia;

- Subject has a known allergy to IFN-beta or the excipient(s) of the study medication;

- Subject has any condition that could interfere with the MRI evaluation;

- Subject has a known allergy to gadolinium-DTPA;

- Subject has previously participated in this study;

- Subject has participated in any clinical trial within the past 6 months;

- Subject has received any immunomodulatory or immunosuppressive therapy at any time

prior to study enrolment, including, but not limited to, the following products: any interferon, glatiramer acetate (Copolymer I), yclophosphamide, cyclosporine, methotrexate, linomide, azathioprine, mitoxantrone, eriflunomide, laquinimod, cladribine, total lymphoid irradiation, anti- lymphocyte monoclonal antibody treatment (e. g. natalizumab, lemtuzumab/Campath, anti-CD4), IvIg, cytokines or anti-cytokine therapy;

- Subject has received any experimental MS treatment prior to study entry, including,

but not limited to, any statins (if given to prevent MS) and pentoxyfilline;

- Subject has a history of alcohol or drug abuse;

- Subject has intolerance or any contraindication to both paracetamol (acetaminophen)

and ibuprofen;

- Inability to administer subcutaneous injections either by self or by caregiver

- Subject has moderate to severe renal impairment

Local Medical Information Office - Geneva, Switzerland, Phone: +41-41-747-0812

Research Site, Mendoza, Argentina; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Sydney, Australia; Recruiting
Local Medical Information Office, Phone: +612-8977-4134

Research Site, Innsbruck, Austria; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Graz, Austria; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, B-Leuven, Belgium; Recruiting
Local Medical Information Office, Phone: +317-030-25741

Research Site, Brugge, Belgium; Recruiting
Local Medical Information Office, Phone: +317-030-25741

Research Site, Varna, Bulgaria; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Sofia, Bulgaria; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Shumen, Bulgaria; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Rousse, Bulgaria; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Pleven, Bulgaria; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Ontario, Canada; Recruiting
Local Medical Information Office, Phone: +905-919-0162

Research Site, Montreal, Quebec, Canada; Recruiting
Local Medical Information Office, Phone: +905-919-0162

Research Site, Victoria British Columbia, Canada; Recruiting
Local Medical Information Office, Phone: +905-919-0162

Research Site, Zagreb, Croatia; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Karlovac, Croatia; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Split, Croatia; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Rijeka, Croatia; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Osijek, Croatia; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Prague, Czech Republic; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Olomouc, Czech Republic; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Hradec Kralove, Czech Republic; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Tallinn, Estonia; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Tartu, Estonia; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Vantaa, Finland; Recruiting
Local Medical Information Office, Phone: +358-985-202-328

Research Site, OYS, Finland; Recruiting
Local Medical Information Office, Phone: +358-985-202-328

Research Site, Paris, France; Recruiting
Local Medical Information Office, Phone: +33-1476-12661

Research Site, Poissy Cedex, France; Recruiting
Local Medical Information Office, Phone: +33-1476-12661

Research Site, Munich, Germany; Recruiting
Local Medical Information Office, Phone: 0800-73-243-44

Research Site, Hannover, Germany; Recruiting
Local Medical Information Office, Phone: 0800-73-243-44

Research Site, Henningsdorf, Germany; Recruiting
Local Medical Information Office, Phone: 0800-73-243-44

Research Site, Athens, Greece; Recruiting
Local Medical Information Office, Phone: +30-210-616-5109

Research Site, Ness Ziona, Israel; Recruiting
Local Medical Information Office, Phone: +972-9740-0689

Research Site, Tel-Hashomer, Israel; Recruiting
Local Medical Information Office, Phone: +972-9740-0689

Research Site, Safed, Israel; Recruiting
Local Medical Information Office, Phone: +972-9740-0689

Research Site, Roma, Italy; Recruiting
Local Medical Information Office, Phone: +39-0670-384-651

Research Site, Padova, Italy; Recruiting
Local Medical Information Office, Phone: +39-0670-384-651

Research Site, Catania, Italy; Recruiting
Local Medical Information Office, Phone: +39-0670-384-651

Research Site, Milano, Italy; Recruiting
Local Medical Information Office, Phone: +39-0670-384-651

Research Site, Riga, Latvia; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Beirut, Lebanon; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Rabat, Morocco; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Warsaw, Poland; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Wroclaw, Poland; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Bialystok, Poland; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Lodz, Poland; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Lisboa, Portugal; Recruiting
Local Medical Information Office, Phone: +34-917-454-464

Research Site, Bucharest, Romania; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Targu-Mures, Romania; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Iasi, Romania; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Timisoara, Romania; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Nizhny Novgorod, Russian Federation; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Moscow, Russian Federation; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Ekaterinburg, Russian Federation; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Saint-Petersburg, Russian Federation; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Saratov, Russian Federation; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Novosibirsk, Russian Federation; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Samara, Russian Federation; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Riyadh, Saudi Arabia; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Belgrade, Serbia; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Nis, Serbia; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Presov, Slovakia; Recruiting
Local Medical Information Office, Phone: +41-41-747-0812

Research Site, Madrid, Spain; Recruiting
Local Medical Information Office, Phone: +34-917-454-464

Research Site, Barcelona, Spain; Recruiting
Local Medical Information Office, Phone: +34-917-454-464

Research Site, Sevilla, Spain; Recruiting
Local Medical Information Office, Phone: +34-917-454-464

Research Site, Bilbao, Spain; Recruiting
Local Medical Information Office, Phone: +34-917-454-464

Research Site, Istanbul, Turkey; Recruiting
Local Medical Information Office, Phone: +90-216-578-6622

Full FDA approved prescribing information can be found here

Starting date: December 2006
Ending date: August 2011
Last updated: January 12, 2009