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Exploratory Study of the Safety, Tolerability and Efficacy of Multiple Regimens of Natalizumab in Adult Participants With Relapsing Multiple Sclerosis (MS)

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing-Remitting Multiple Sclerosis

Intervention: natalizumab IV (Drug); natalizumab SC (Drug); IV Placebo (Drug); SC Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Biogen

Summary

The primary objective of this study is to explore the effects of multiple regimens of natalizumab on disease activity and safety in participants with relapsing-remitting Multiple Sclerosis (RRMS).

Clinical Details

Official title: A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Cumulative Number of Combined Unique Active Lesions

Detailed description: This is a a dose and frequency (but not route of administration) blinded, prospective, randomized, dose-ranging study in patients with RRMS who have received natalizumab for at least 12 months according to the local prescribing guidelines. The study will explore dosing of natalizumab by subcutaneous and intravenous routes. Participants will be randomly assigned to 1 of 6 dosing regimens, blinded to natalizumab dose, but not route, for 60 weeks of treatment.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Key Inclusion Criteria:

- Ability to provide written informed consent

- Subjects of childbearing potential must practice effective contraception during the

study

- A documented diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS)

- Free of MS relapse for 12 months prior to randomization

- Treatment with natalizumab for a minimum of 12 months immediately prior to

randomization.

- In the 12 months prior to commencing natalizumab, subject must have experienced a

minimal level of disease activity as defined by 2 or more documented clinical relapses OR 1 relapse and documented MRI activity, defined by the presence of at least 1 Gd enhancing lesion on MRI, unrelated to the relapse. Key Exclusion Criteria:

- Known history of Human Immunodeficiency Virus (HIV), hepatitis C and/or hepatitis B

virus

- Positive for anti-natalizumab antibodies at screening

- MRI positive for Gd-enhancing lesions at study entry

- Subjects for whom MRI is contraindicated

- History of any clinically significant cardiac, endocrinologic, hematologic, hepatic,

immunologic, metabolic (including diabetes), urologic, pulmonary, neurologic (except for RRMS), dermatologic, psychiatric, renal, or other major disease

- History of malignant disease, including solid tumors and hematologic malignancies

(with the exception of cured basal cell and squamous cell carcinomas of the skin)

- History of transplantation or any anti-rejection therapy

- History of severe allergic or anaphylactic reactions or known hypersensitivity to any

drug

- A clinically significant infectious illness within 30 days prior to screening or

progressive multifocal leukoencephalopathy (PML) or other opportunistic infections at any time

- Signs or symptoms suggestive of any serious infection, based on medical history,

physical examination or laboratory testing NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations and Contacts

Research Site, Brasschaat, Belgium

Research Site, Liege, Belgium

Research Site, Overpelt, Belgium

Research Site, Wilrijk, Belgium

Research Site, Amiens cedex 1, France

Research Site, Besançon Cedex, France

Research Site, Bron cedex, France

Research Site, Lille Cedex, France

Research Site, Montpellier, France

Research Site, Nantes Cedex 01, France

Research Site, Nice cedex, France

Research Site, Paris Cedex, France

Research Site, Rennes Cedex 9, France

Research Site, Strasbourg, France

Research Site, Toulouse cedex 9, France

Research Site, Andernach, Germany

Research Site, Bamberg, Germany

Research Site, Berlin, Germany

Research Site, Bochum, Germany

Research Site, Bonn, Germany

Research Site, Dresden, Germany

Research Site, Emmendingen, Germany

Research Site, Erbach, Germany

Research Site, Erlangen, Germany

Research Site, Frankfurt, Germany

Research Site, Freiburg, Germany

Research Site, Heidelberg, Germany

Research Site, Jena, Germany

Research Site, Mainz, Germany

Research Site, Marburg, Germany

Research Site, München, Germany

Research Site, Neuburg, Germany

Research Site, Regensburg, Germany

Research Site, Tuebingen, Germany

Research Site, Ulm, Germany

Research Site, Wermsdorf, Germany

Research Site, Bari, Italy

Research Site, Catania, Italy

Research Site, Cefalù, Italy

Research Site, Chieti, Italy

Research Site, Firenze, Italy

Research Site, Gallarate, Italy

Research Site, L'Aquila, Italy

Research Site, Milano, Italy

Research Site, Montichiari, Italy

Research Site, Napoli, Italy

Research Site, Orbassano, Italy

Research Site, Padova, Italy

Research Site, Palermo, Italy

Research Site, Pavia, Italy

Research Site, Pozzilli, Italy

Research Site, Roma, Italy

Research Site, Sassari, Italy

Research Site, Torino, Italy

Research Site, Barcelona, Spain

Research Site, Girona, Spain

Research Site, Lleida, Spain

Research Site, Malaga, Spain

Research Site, Murcia, Spain

Research Site, Oviedo, Spain

Research Site, Pamplona, Spain

Research Site, San Sebastian, Spain

Research Site, Santa Cruz de Tenerife, Spain

Research Site, Sevilla, Spain

Additional Information

Starting date: August 2011
Last updated: August 3, 2015

Page last updated: August 23, 2015

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