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

July 14, 2011
September 12, 2013
August 2011
August 2014   (final data collection date for primary outcome measure)
  • 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 ]
The cumulative number of new active lesions compared to baseline brain MRI scans at week 60 [ Time Frame: Baseline to week 60 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01405820 on ClinicalTrials.gov Archive Site
Not Provided
The number of participants with adverse events [ Time Frame: Participants will be followed for the duration of the study; an expected 72 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Exploratory Study of the Safety, Tolerability and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis (MS).
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).

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Relapsing Multiple Sclerosis
  • Drug: Natalizumab
    300 mg Intravenous (IV) every 4 weeks
    Other Names:
    • Tysabri
    • BG00002
  • Drug: Natalizumab
    300 mg Subcutaneous (SC) every 4 weeks
    Other Names:
    • Tysabri
    • BG00002
  • Drug: Natalizumab
    300 mg Intravenous (IV) every 12 weeks
    Other Names:
    • Tysabri
    • BG00002
  • Drug: Natalizumab
    300 mg Subcutaneous (SC) every 12 weeks
    Other Names:
    • Tysabri
    • BG00002
  • Drug: Natalizumab
    150 mg Intravenous (IV) every 12 weeks
    Other Names:
    • Tysabri
    • BG00002
  • Drug: Natalizumab
    150 mg Subcutaneous (SC) every 12 weeks
    Other Names:
    • Tysabri
    • BG00002
  • Drug: Placebo
    300 mg Intravenous (IV) administered during the intervening 4 week periods
  • Drug: Placebo
    300 mg Subcutaneous (SC) administered during the intervening 4 week periods
  • Drug: Placebo
    150 mg Intravenous (IV) administered during the intervening 4 week periods
  • Drug: Placebo
    150 mg Subcutaneous (SC) administered during the intervening 4 week periods
  • Experimental: Natalizumab 300 mg Intravenous (IV) every 4 weeks
    All subjects will receive Intravenous (IV) Natalizumab 300 mg every 4 weeks.
    Intervention: Drug: Natalizumab
  • Experimental: Natalizumab 300 mg Subcutaneous (SC) every 4 weeks
    All subjects will receive Subcutaneous (SC) Natalizumab 300 mg every 4 weeks.
    Intervention: Drug: Natalizumab
  • 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.
    Interventions:
    • Drug: Natalizumab
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Natalizumab
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Natalizumab
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Natalizumab
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
291
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Germany,   Italy,   Spain
 
NCT01405820
101MS206
Yes
Biogen Idec
Biogen Idec
Not Provided
Not Provided
Biogen Idec
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP