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Trial record 35 of 120 for:    COP1

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

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ClinicalTrials.gov Identifier: NCT01633112
Recruitment Status : Terminated (slow recruitment)
First Posted : July 4, 2012
Results First Posted : May 27, 2019
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this study was to demonstrate that at least one dose (0.5 mg followed by 0.25 mg) of fingolimod is superior to glatiramer acetate 20 mg SC in reducing the ARR up to 12 months in patients with relapsing-remitting MS

Condition or disease Intervention/treatment Phase
Relapsing-remitting Multiple Sclerosis (RRMS) Drug: fingolimod Drug: glatiramer acetate Phase 3

Detailed Description:

This was 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 consisted of 3 periods:

  • Screening Period: up to 45 days for all patients
  • Treatment Period: 12 months of glatiramer acetate 20 mg, fingolimod 0.25 mg, or fingolimod 0.5 mg
  • Follow-up occurred 3 months (12 weeks) after the last dose of study drug for all patients The informed consent form was signed prior to any study related activities at the screening visit. Randomization to either treatment group was preformed at visit 1 after a diligent check of applicable in- and exclusion criteria in a 1:1:1 ratio (changed to 5:3:2 after implementation of Amendment 2 in 2015).

Treatment groups:

  • fingolimod 0.5 mg/day orally for up to 12 months
  • fingolimod 0.25 mg/day orally for up to 12 months
  • glatiramer acetate 20 mg/day subcutaneously for up to 12 months

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1064 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Fingolimod patients were dose blind.
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
Actual Study Start Date : August 9, 2012
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: fingolimod 0.5 mg
orally once daily
Drug: fingolimod
capsule
Other Names:
  • FTY720, fingolimod hydrochloride,
  • Gilenya

Experimental: fingolimod 0.25mg
orally once daily
Drug: fingolimod
capsule
Other Names:
  • FTY720, fingolimod hydrochloride,
  • Gilenya

Active Comparator: glatiramer acetate 20 mg
subcutaneous once daily
Drug: glatiramer acetate
subcutaneous injection
Other Name: Copaxone, Glatopa




Primary Outcome Measures :
  1. Confirmed Annualized Relapse Rate [ Time Frame: up to 12 months ]
    Annualized relapse rate (ARR) was 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 included all the confirmed relapses experienced during the study from first dose to end of study.


Secondary Outcome Measures :
  1. New or Newly Enlarging T2 Lesions [ Time Frame: At 12 months/end of study ]
    Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion count.

  2. Number of Participants Free of New/Newly Enlarged T2 Lesions [ Time Frame: At 12 months/end of study ]
    Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion count.

  3. Change From Baseline in T2 Lesion Volume [ Time Frame: Baseline, 12 months/end of study ]
    Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion volume

  4. Gd Enhancing T1 Lesion Count [ Time Frame: At 12 months/end of study ]
    Inflammatory activity based on MRI measurement of Gd enhancing T1 lesion count

  5. Gd Enhancing T1 Lesion Volume [ Time Frame: Baseline, 12 months/end of study ]
    Inflammatory activity based on MRI measurement of Gd enhancing T1 lesion count

  6. Percentage of Patients Free of New T1 Hypointense Lesions [ Time Frame: 12 months ]
    Based on MRI measures of new T1 hypointense lesions

  7. Change From Baseline in TSQM Scales [ Time Frame: 6 months, 12 months/end of study ]
    Treatment Satisfaction Questionnaire for Medication (TSQM) was developed and validated as a general measure for treatment satisfaction. Each scale score was calculated by summing individual items and then transformed to a 0—100 scale. Higher summary scores indicate better satisfaction with study drug.

  8. Percent Brain Volume Change From Baseline [ Time Frame: Baseline, 12 months, end of study ]
    Using a Central MRI vendor to ensure calibrated MRI scanning equipment across all sites, MRI scans were performed on subjects following the established parameters and transferred to the central vendor for review of quality and assessment/evaluation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 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.

Exclusion criteria:

  • Patients with a history of malignancy of any organ system (other than cutaneous basal cell carcinoma) in the last 5 years that do not have confirmation of absence of a malignancy prior to randomization
  • 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 4 weeks before randomization
  • Immunosuppressive/chemotherapeutic medications (e.g., azathioprine, cyclophosphamide, methotrexate) within 6 months before randomization
  • Natalizumab within 2 months before randomization
  • Previous treatment with lymphocyte-depleting therapies (e.g., rituximab, alemtuzumab, ofatumumab, ocrelizumab, or cladribine) within 1 year before randomization Previous treatment with mitoxantrone within 6 months before randomization
  • Use of teriflunomide within 3.5 months prior to randomization, except if active washout (with either cholestyramine or activated charcoal) was done. In that case, plasma levels are required to be measured and be below 0.02 mg/L before randomization.

No washout period is necessary for patients treated with dimethyl fumarate, interferon (IFN) beta, or glatiramer acetate.

Patients being treated with dimethyl fumarate, glatiramer acetate, or IFN beta at the Screening visit can continue drug intake up to the day before Day 1 of this study (i.e., there is no need for a washout period).

  • Patients who have been treated with systemic corticosteroids or adrenocorticotropic hormones in the past 30 days prior to the screening magnetic resonance imaging (MRI) procedure.
  • Patients with uncontrolled diabetes mellitus (glycosylated hemoglobin >9%) or with diabetic neuropathy.
  • 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).
  • Patients with severe active bacterial, viral, or fungal infections.
  • Patients without acceptable evidence of immunity to varicella zoster virus (VZV) at randomization.
  • Patients who have received any live or live-attenuated vaccines (including VZV, 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.
  • Patients who in the last 6 months experienced any of the following cardiovascular conditions or findings in the screening electrocardiogram (ECG): myocardial infarction, unstable angina, stroke, transient ischemic attack or decompensated heart failure requiring hospitalization or Class III/IV heart failure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01633112


  Show 130 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] July 20, 2015
Statistical Analysis Plan  [PDF] November 2, 2018


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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01633112     History of Changes
Other Study ID Numbers: CFTY720D2312
First Posted: July 4, 2012    Key Record Dates
Results First Posted: May 27, 2019
Last Update Posted: May 27, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

URL: https://www.clinicalstudydatarequest.com
Additional relevant MeSH terms:
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Glatiramer Acetate
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Fingolimod Hydrochloride
(T,G)-A-L
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antirheumatic Agents