Clinical trial NCT01405820: Exploratory Study of the Safety, Tolerability and Efficacy of Multiple Regimens of Natalizumab in Adult Participants With Relapsing Multiple Sclerosis (MS)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsing-Remitting Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2011-07-29
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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 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.

Primary outcomes:
measure: Cumulative Number of Combined Unique Active Lesions
timeFrame: Up to Week 60
Secondary outcomes:
Other outcomes:
Locations:
city: Brasschaat
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Overpelt
country: Belgium
facility: Research Site
city: Wilrijk
country: Belgium
facility: Research Site
city: Amiens cedex 1
country: France
facility: Research Site
city: Besançon Cedex
country: France
facility: Research Site
city: Bron cedex
country: France
facility: Research Site
city: Lille Cedex
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Nantes Cedex 01
country: France
facility: Research Site
city: Nice cedex
country: France
facility: Research Site
city: Paris Cedex
country: France
facility: Research Site
city: Rennes Cedex 9
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Toulouse cedex 9
country: France
facility: Research Site
city: Andernach
country: Germany
facility: Research Site
city: Bamberg
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bochum
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Emmendingen
country: Germany
facility: Research Site
city: Erbach
country: Germany
facility: Research Site
city: Erlangen
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Jena
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Marburg
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Neuburg
country: Germany
facility: Research Site
city: Regensburg
country: Germany
facility: Research Site
city: Tuebingen
country: Germany
facility: Research Site
city: Ulm
country: Germany
facility: Research Site
city: Wermsdorf
country: Germany
facility: Research Site
city: Bari
country: Italy
facility: Research Site
city: Catania
country: Italy
facility: Research Site
city: Cefalù
country: Italy
facility: Research Site
city: Chieti
country: Italy
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Gallarate
country: Italy
facility: Research Site
city: L'Aquila
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Montichiari
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Orbassano
country: Italy
facility: Research Site
city: Padova
country: Italy
facility: Research Site
city: Palermo
country: Italy
facility: Research Site
city: Pavia
country: Italy
facility: Research Site
city: Pozzilli
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Sassari
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Girona
country: Spain
facility: Research Site
city: Lleida
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Murcia
country: Spain
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
city: Pamplona
country: Spain
facility: Research Site
city: San Sebastian
country: Spain
facility: Research Site
city: Santa Cruz de Tenerife
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: