MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01633112
First received: June 29, 2012
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to compare 2 doses (0.25 mg and 0.50 mg) of fingolimod to glatiramer acetate (20 mg) and to evaluate the efficacy of fingolimod 0.25 mg for the treatment of patients with relapsing-remitting MS (RRMS).


Condition Intervention Phase
Relapsing-remitting Multiple Sclerosis (RRMS)
Drug: fingolimod
Drug: copaxone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 12-month, Randomized, Rater- and Dose-blinded Study to Compare the Efficacy and Safety of Fingolimod 0.25 mg and 0.5 mg Administered Orally Once Daily With Glatiramer Acetate 20 mg Administered Subcutaneously Once Daily in Patients With Relapsing-remitting Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Comparison of 2 doses (0.25 mg and .5 mg) of fingolimod to glatiramer acetate (20 mg) in reducing the annualized relapse rate up to 12 months [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    The annualized relapse rate (ARR) which is defined as the average number of confirmed relapses per year (i.e., the total number of confirmed relapses divided by the total days in the study multiplied by 365.25). The number of relapses will include all the confirmed relapses experienced during the study from first dose to end of study.


Secondary Outcome Measures:
  • change from Baseline in brain volume [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Using a Central MRI vendor to ensure calibrated MRI scanning equipment across all sites, MRI scans will be performed on subjects following the established parameters and transferred to the central vendor for review of quality and assessment/evaluation.

  • number of active T2 lesions (new or newly enlarging lesions compared with Baseline) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Using a Central MRI vendor to ensure calibrated MRI scanning equipment across all sites, MRI scans will be performed on subjects following the established parameters and transferred to the central vendor for review of quality and assessment/evaluation.

  • proportion of patients free of new or newly enlarging T2 lesions compared to Baseline [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Using a Central MRI vendor to ensure calibrated MRI scanning equipment across all sites, MRI scans will be performed on subjects following the established parameters and transferred to the central vendor for review of quality and assessment/evaluation.

  • change from Baseline in T2 lesion volume [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Using a Central MRI vendor to ensure calibrated MRI scanning equipment across all sites, MRI scans will be performed on subjects following the established parameters and transferred to the central vendor for review of quality and assessment/evaluation.

  • change from Baseline in the number and volume of T1 hypointense lesions [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Using a Central MRI vendor to ensure calibrated MRI scanning equipment across all sites, MRI scans will be performed on subjects following the established parameters and transferred to the central vendor for review of quality and assessment/evaluation.

  • number and volume of gadolinium (Gd)-enhancing T1 lesions [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Using a Central MRI vendor to ensure calibrated MRI scanning equipment across all sites, MRI scans will be performed on subjects following the established parameters and transferred to the central vendor for review of quality and assessment/evaluation.

  • safety and tolerability [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Using a Central MRI vendor to ensure calibrated MRI scanning equipment across all sites, MRI scans will be performed on subjects following the established parameters and transferred to the central vendor for review of quality and assessment/evaluation.

  • change from baseline in treatment satisfaction as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Using a Central MRI vendor to ensure calibrated MRI scanning equipment across all sites, MRI scans will be performed on subjects following the established parameters and transferred to the central vendor for review of quality and assessment/evaluation.


Estimated Enrollment: 2550
Study Start Date: August 2012
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fingolimod 0.5 mg orally once daily Drug: fingolimod
Other Name: FTY720
Experimental: fingolimod 0.25mg orally once daily Drug: fingolimod
Other Name: FTY720
Active Comparator: copaxone 20 mg s.c. once daily Drug: copaxone
copaxone

Detailed Description:

This is a multicenter, randomized, rater- and dose-blinded, study to compare the efficacy and safety of 0.25 mg and 0.5 mg of fingolimod with glatimer acetate 20 mg s.c. in patients with RRMS.

This study will consist of 3 periods:

  • Screening Period: up to 1 month for all patients
  • Treatment Period: 12 months of glatiramer acetate 20 mg, fingolimod 0.25 mg, or fingolimod 0.5 mg
  • Follow-up will occur 3 months (12 weeks) after the last dose of study drug for all patients

After signing the informed consent, patients will enter the Screening Period to determine eligibility for the study. After inclusion/exclusion criteria are reviewed again and after safety assessments are conducted, patients will enter the Treatment Period and will be randomly assigned into 1 of 3 groups in a 1:1:1 ratio:

  • Group 1 will receive fingolimod 0.5 mg orally once a day for up to 12 months
  • Group 2 will receive fingolimod 0.25 mg orally once a day for up to 12 months
  • Group 3 will receive glatiramer acetate 20 mg subcutaneously once a day for up to 12 months
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Written informed consent must be obtained before any assessment is performed
  • Male and female patients 18 to 65 years of age, inclusive.
  • Patients with RRMS, as defined by 2010 revised McDonald criteria.
  • Patients must be neurologically stable with no onset of relapse or any steroid use within 30 days of randomization
  • Patients with at least 1 documented relapse during the previous year or 2 documented relapses during the previous 2 years before randomization.
  • Patients with an EDSS score of 0 to 6 inclusive at Screening. A score of 6.0 indicates unilateral assistance (cane or crutch) required to walk at least 100 meters with or without resting.
  • Patients treated with interferon beta or glatimer acetate can continue their treatment until randomization

Exclusion criteria:

  • Patients with a history of malignancy of any organ system (other than cutaneous basal cell carcinoma)
  • Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjogren's syndrome, Crohn's disease, ulcerative colitis) or with a known immunodeficiency syndrome (HIV-antibody positive, AIDS, hereditary immune deficiency, drug-induced immune deficiency).
  • Patients who have been treated with:
  • High-dose intravenous (IV) immunoglobulin (Ig) within 2 months before randomization
  • Immunosuppressive/chemotherapeutic medications (e.g., azathioprine, cyclophosphamide, methotrexate) within 6 months before randomization
  • Monoclonal antibodies (including natalizumab) within 6 months before randomization
  • Rituximab, alemtuzumab, ofatumumab, ocrelizumab, mitoxantrone or cladribine at any time before randomization
  • Patients who have been treated with corticosteroids or adrenocorticotropic hormones in the past 30 days before the screening visit
  • Patients with uncontrolled diabetes mellitus (HbA1c >7%)
  • Patients with a diagnosis of macular edema during Screening (patients with a history of macular edema will be allowed to enter the study provided that they do not have macular edema at Screening)
  • Positive screening for serological markers for hepatitis A, B, C, and E indicating acute or chronic infection:
  • Patients who are negative for varicella zoster virus IgG antibodies at Screening
  • Patients who have received any live or live attenuated vaccines (including for varicella zoster virus, herpes simplex, or measles) within 1 month before randomization
  • Patients who have received total lymphoid irradiation or bone marrow transplantation
  • Patients with any unstable medical/psychiatric condition, as assessed by the primary treating physician at each site
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01633112

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Show 217 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01633112     History of Changes
Other Study ID Numbers: CFTY720D2312
Study First Received: June 29, 2012
Last Updated: September 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Fingolimod
Copolymer 1
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on September 18, 2014