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Trial record 67 of 120 for:    COP1

Observational Study to Characterize Real-world Clinical Outcomes With Relapsing-remitting Multiple Sclerosis (RRMS) (EFFECT)

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ClinicalTrials.gov Identifier: NCT02776072
Recruitment Status : Completed
First Posted : May 18, 2016
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief Summary:

The primary objective of the study is to evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with dimethyl fumarate (DMF).

Secondary objectives of the study are: To evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with DMF, glatiramer acetate (GA), teriflunomide, or fingolimod both in the overall participant cohort and in a subset of participants who were naïve to disease-modifying therapy (DMT) and were diagnosed with multiple sclerosis (MS) within 3 years of starting the index therapy; To compare relapse activity, defined as annualized relapse rate (ARR), among participants treated with DMF, GA, teriflunomide, or fingolimod; To compare MS-related hospitalizations among participants treated with DMF, GA, teriflunomide, or fingolimod; To compare intravenous corticosteroid use among participants treated with DMF, GA, teriflunomide, or fingolimod.


Condition or disease
Multiple Sclerosis

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Study Type : Observational
Actual Enrollment : 2978 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: A Multicenter, Global, Retrospective, Observational Study to Characterize Real-world Clinical Outcomes in Patients With Relapsing-remitting Multiple Sclerosis Treated With Disease-modifying Therapies (Tecfidera®, Copaxone®, Aubagio®, or Gilenya®)
Study Start Date : May 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016


Group/Cohort
dimethyl fumarate (DMF)
Participants who initiated DMF during the specified time period
glatiramer acetate (GA)
Participants who initiated GA during the specified time period
teriflunomide
Participants who initiated teriflunomide during the specified time period
fingolimod
Participants who initiated fingolimod during the specified time period



Primary Outcome Measures :
  1. Proportion of participants relapsed at 12 months in participants treated with DMF [ Time Frame: One day ]
    Single time point per participant retrospective medical record abstraction with no required study visits or procedures


Secondary Outcome Measures :
  1. Proportion of participants relapsed at 12 months treated with index therapy in the overall population as well as the subgroup of MS participants who were naïve to DMTs and were diagnosed with MS within 3 years of starting the index therapy [ Time Frame: One day ]
    Single time point per participant retrospective medical record abstraction with no required study visits or procedures

  2. ARR at 12 months in participants treated with index therapy in the overall population as well as in the matched cohorts [ Time Frame: One day ]
    Single time point per participant retrospective medical record abstraction with no required study visits or procedures

  3. Proportion of relapsed participants with one or more MS-related hospitalizations during the 12 months following treatment initiation in participants treated with index therapy in the overall population and the matched cohorts [ Time Frame: One day ]
    Single time point per participant retrospective medical record abstraction with no required study visits or procedures

  4. Proportion of relapsed participants requiring treatment with intravenous corticosteroids during the 12 months following treatment initiation in participants treated with index therapy in the overall participant population and the matched cohorts [ Time Frame: One day ]
    Single time point per participant retrospective medical record abstraction with no required study visits or procedures



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with a diagnosis of RRMS treated with dimethyl fumarate, fingolimod, teriflunomide, or glatiramer acetate in routine clinical practice.
Criteria

Key Inclusion Criteria:

  • Diagnosis of RRMS per McDonald criteria
  • Initiated treatment with DMF, GA, teriflunomide, or fingolimod (defined as index therapy) no earlier than January 2011 and no later than 12 months prior to the date of medical record abstraction (i.e., patient has at least 12 months of data available in the medical record following initiation of index treatment). Note: Patients who have initiated the index therapy but subsequently discontinued or switched to other therapies are allowed in this study as long as there is at least 12 months of follow-up following the initiation of the index therapy.
  • Have sufficient available medical records for data abstraction to meet the objectives of the study, i.e., the patient was either under the medical care of the investigating site during the entire period of the index treatment or the patient's complete MS disease and treatment history is otherwise available at the investigating site

Key Exclusion Criteria:

  • Diagnosis of a progressive form of MS (progressive relapsing, primary progressive, secondary progressive) at any time before or during the period for which data will be collected
  • Have received disease-modifying therapies other than one platform therapy (IFN or GA) prior to initiation of index therapy. In patients for whom GA is index therapy, only one prior IFN therapy is allowed.
  • Have received any formulations of DMF, Fumaderm®, or compounded fumarates (e.g., Psorinovo) at any time prior to initiation of treatment with Tecfidera®
  • Concurrent enrollment in any interventional clinical trial of an investigational product during time evaluated for medical record abstraction

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply


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): NCT02776072


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Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen

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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02776072     History of Changes
Other Study ID Numbers: 109MS421
First Posted: May 18, 2016    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017
Keywords provided by Biogen:
Tecfidera, DMF, dimethyl fumarate, Fingolimod, Glatiramer acetate, Teriflunomide, Gilenya, Copaxone, Aubagio
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
Dimethyl Fumarate
Fingolimod Hydrochloride
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antirheumatic Agents
Dermatologic Agents