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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01405820
First received: July 14, 2011
Last updated: September 12, 2013
Last verified: May 2013
  Purpose

The primary objective of this study is to explore the effects of multiple regimens of natalizumab on disease activity and safety in subjects with relapsing and remittiing Multiple Sclerosis (MS). This study will explore both Subcutaneous (SC) and IV routes of administration.


Condition Intervention Phase
Relapsing Multiple Sclerosis
Drug: Natalizumab
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 (MS).

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • The cumulative number of new active lesions compared to baseline brain Magnetic Resonance Imaging (MRI) scans at week 60 [ Time Frame: Baseline to week 60 ] [ Designated as safety issue: Yes ]
  • The number of participants with adverse events. [ Time Frame: Patients will be followed for the duration of the study; expected 72 weeks. ] [ Designated as safety issue: Yes ]

Enrollment: 291
Study Start Date: August 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Natalizumab 300 mg Intravenous (IV) every 4 weeks
All subjects will receive Intravenous (IV) Natalizumab 300 mg every 4 weeks.
Drug: Natalizumab
300 mg Intravenous (IV) every 4 weeks
Other Names:
  • Tysabri
  • BG00002
Experimental: Natalizumab 300 mg Subcutaneous (SC) every 4 weeks
All subjects will receive Subcutaneous (SC) Natalizumab 300 mg every 4 weeks.
Drug: Natalizumab
300 mg Subcutaneous (SC) every 4 weeks
Other Names:
  • Tysabri
  • BG00002
Experimental: Natalizumab 300 mg Intravenous (IV) every 12 weeks.
All subjects will receive Intravenous (IV) Natalizumab 300 mg every 12 weeks. Placebo will be administered during the intervening 4 week periods.
Drug: Natalizumab
300 mg Intravenous (IV) every 12 weeks
Other Names:
  • Tysabri
  • BG00002
Drug: Placebo
300 mg Intravenous (IV) administered during the intervening 4 week periods
Experimental: Natalizumab 300 mg Subcutaneous (SC) every 12 weeks.
All subjects will receive Subcutaneous (SC) Natalizumab 300 mg every 12 weeks. Placebo will be administered during the intervening 4 week periods.
Drug: Natalizumab
300 mg Subcutaneous (SC) every 12 weeks
Other Names:
  • Tysabri
  • BG00002
Drug: Placebo
300 mg Subcutaneous (SC) administered during the intervening 4 week periods
Experimental: Natalizumab 150 mg Intravenous (IV) every 12 weeks.
All subjects will receive Intravenous (IV) Natalizumab 150 mg every 12 weeks. Placebo will be administered during the intervening 4 week periods.
Drug: Natalizumab
150 mg Intravenous (IV) every 12 weeks
Other Names:
  • Tysabri
  • BG00002
Drug: Placebo
150 mg Intravenous (IV) administered during the intervening 4 week periods
Experimental: Natalizumab 150 mg Subcutaneous (SC) every 12 weeks.
All subjects will receive Subcutaneous (SC) Natalizumab 150 mg every 12 weeks. Placebo will be administered during the intervening 4 week periods.
Drug: Natalizumab
150 mg Subcutaneous (SC) every 12 weeks
Other Names:
  • Tysabri
  • BG00002
Drug: Placebo
150 mg Subcutaneous (SC) administered during the intervening 4 week periods

Detailed Description:

This is a blinded, prospective, randomized, dose ranging study in subjects with relapsing Multiple Sclerosis (MS) who have received natalizumab for at least 12 months according to the local prescribing guidelines.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • In the 12 months prior to commencing natalizumab, subject must have experienced a minimal level of disease activity as defined by the protocol

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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01405820

Locations
Belgium
Research Site
Brasschaat, Belgium
Research Site
Liege, Belgium
Research Site
Wilrijk, Belgium
Germany
Research Site
Bochum, Germany
Research Site
Dresden, Germany
Research Site
Frankfurt, Germany
Research Site
Freiburg, Germany
Research Site
Jena, Germany
Research Site
Marburg, Germany
Research Site
Ulm, Germany
Italy
Research Site
Chieti, Italy
Spain
Research Site
Girona, Spain
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01405820     History of Changes
Other Study ID Numbers: 101MS206
Study First Received: July 14, 2011
Last Updated: September 12, 2013
Health Authority: Italy: Ethics Committee
France: Institutional Ethical Committee
Spain: Comité Ético de Investigación Clínica
Belgium: Institutional Review Board
Germany: Ethics Commission

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014