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Relapsing Forms of Multiple SclerosisRESPONDNCT01903291

Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS

An observational study of Relapsing Forms of Multiple Sclerosis, run by Biogen at 62 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the study is to estimate the annualized relapse rate (ARR) over a 12-month period in patients with relapsing forms of multiple sclerosis (MS) who are treated with dimethyl fumarate (DMF) after suboptimal response to glatiramer acetate (GA). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsing Forms of Multiple Sclerosis
What is being tested?
dimethyl fumarate
How many people
333 participants
Where
62 sitesUnited States
Study dates
Aug 2013to Feb 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This study will be conducted in male and female patients with relapsing forms of MS who satisfy the therapeutic indication for dimethyl fumarate (DMF) per the United States Prescribing Information, and who are suboptimal responders to glatiramer acetate (GA), as determined by the Prescribing Physician.

Who may be able to join

  • Have the ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use Protected Health Information in accordance with national and local patient privacy regulations.
  • Have the ability to read and understand written English.
  • Have access to the internet and are able to complete online assessments on a computer
  • Have a relapsing form of Multiple Sclerosis and satisfy the approved therapeutic indication for dimethyl fumarate (DMF) per the United States Prescribing Information (USPI).
  • Are being treated for relapsing forms of multiple sclerosis (MS) with glatiramer acetate (GA) but, per the Prescribing Physician, have a suboptimal response (e.g., suboptimal efficacy, intolerance, or poor adherence) to GA or have stopped treatment with GA for relapsing forms of MS as a result of suboptimal response within 30 days of enrollment.
  • Have decided to initiate treatment with dimethyl fumarate (DMF) under routine clinical care. The decision to initiate treatment with DMF must precede enrollment.
  • Have a complete blood count (CBC) available within 6 months of initiation of treatment with dimethyl fumarate (DMF).

Who cannot join

  • Are unwilling or unable to comply with study requirements, or, are deemed unsuitable for study participation at the discretion of the Prescribing Physician.
  • Have major comorbid conditions that would preclude their participation in the study as determined by the Prescribing Physician.
  • Have a history of malignancy. (Patients with basal cell carcinoma that has been completely excised prior to study entry remain eligible.)
  • Have a history of and/or current serious infections.
  • Are pregnant or breastfeeding, or are planning to become pregnant or breastfeed.
  • Are receiving concomitant disease modifying therapies other than glatiramer acetate (GA) or have initiated treatment with a new disease-modifying therapy since discontinuation of glatiramer acetate (GA).
Show all 9Show fewer
  • Are currently enrolled in any other clinical studies, with the exception of the dimethyl fumarate (DMF) Pregnancy Registry.
  • Have received prior treatment with dimethyl fumarate (DMF).
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Trial locations and contacts

62 sites in 1 country.

62 sites in 1 country

United States62 sites

  • Research Site

    Abington, Pennsylvania, 19001

  • Research Site

    Akron, Ohio, 44302

  • Research Site

    Annapolis, Maryland, 21401

  • Research Site

    Asheville, North Carolina, 28806

  • Research Site

    Atlanta, Georgia, 30309

  • Research Site

    Atlanta, Georgia, 30327

  • Research Site

    Baltimore, Maryland, 21201

  • Research Site

    Baton Rouge, Louisiana, 70810-1686

  • Research Site

    Bellingham, Washington, 98225

  • Research Site

    Birmingham, Alabama, 35209

  • Research Site

    Canton, Ohio, 44718

  • Research Site

    Centerville, Ohio, 45459

  • Research Site

    Chicago, Illinois, 60637-1463

  • Research Site

    Clinton Township, Michigan, 48035

  • Research Site

    Columbia, Missouri, 65201

  • Research Site

    Columbus, Ohio, 43221

  • Research Site

    Des Moines, Iowa, 50314

  • Research Site

    Dover, Delaware, 19901

  • Research Site

    Englewood, Colorado, 80113

  • Research Site

    Evanston, Illinois, 60201

  • Research Site

    Franklin, Illinois, 37064

  • Research Site

    Freehold, New Jersey, 07728

  • Research Site

    Golden Valley, Minnesota, 55422

  • Research Site

    Great Falls, Montana, 59405

  • Research Site

    Greensburg, Pennsylvania, 15601

  • Research Site

    Hickory, North Carolina, 28602

  • Research Site

    Indianapolis, Indiana, 46256

  • Research Site

    Jacksonville, Florida, 32209

  • Research Site

    Knoxville, Tennessee, 37934

  • Research Site

    Lenexa, Kansas, 66214-9836

  • Research Site

    Lexington, Kentucky, 40513

  • Research Site

    Lexington, Massachusetts, 02421

  • Research Site

    Lighthouse PT, Florida, 33064

  • Research Site

    Lincoln, Nebraska, 68506-2960

  • Research Site

    Lincoln, Nebraska, 68521

  • Research Site

    Los Angeles, California, 90015

  • Research Site

    Louisville, Kentucky, 40207

  • Research Site

    Medford, Oregon, 97504

  • Research Site

    Muskegon, Michigan, 49444-3719

  • Research Site

    Neenah, Wisconsin, 54946

  • Research Site

    New York, New York, 10032

  • Research Site

    Norfolk, Virginia, 23502

  • Research Site

    Omaha, Nebraska, 68198

  • Research Site

    Patchogue, New York, 11772

  • Research Site

    Pittsburgh, Pennsylvania, 15212

  • Research Site

    Port Charlotte, Florida, 33952

  • Research Site

    Portland, Oregon, 97225

  • Research Site

    Raleigh, North Carolina, 27607-6010

  • Research Site

    Richmond, Virginia, 23226

  • Research Site

    Round Rock, Texas, 78681

  • Research Site

    Sacramento, California, 95816

  • Research Site

    Salt Lake City, Utah, 84103

  • Research Site

    San Jose, California, 95124

  • Research Site

    Savannah, Georgia, 31405

  • Research Site

    Seattle, Washington, 98122

  • Research Site

    Springfield, Massachusetts, 01104

  • Research Site

    St. Petersburg, Florida, 33705

  • Research Site

    Tacoma, Washington, 98405

  • Research Site

    Tampa, Florida, 33612

  • Research Site

    The Bronx, New York, 10467

  • Research Site

    Tuscon, Arizona, 85741-1196

  • Research Site

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: A Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing Forms of Multiple Sclerosis After Suboptimal Response to Glatiramer Acetate

The primary objective of the study is to estimate the annualized relapse rate (ARR) over a 12-month period in patients with relapsing forms of multiple sclerosis (MS) who are treated with dimethyl fumarate (DMF) after suboptimal response to glatiramer acetate (GA). The secondary objectives of this study in this study population are to assess the impact of DMF over a 12-month period on patient-reported outcomes (PROs) and health economic-related outcomes and to evaluate additional clinical outcomes at Month 12.

Being tested
dimethyl fumarate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dimethyl fumarateDrug

    Also called Tecfidera, BG00012, DMF

    As described in the treatment arm

Study groups in NCT01903291
Study groupRoleWhat they receive
dimethyl fumarateTo be taken according to the United States Prescribing Information (USPI)
Receives: Drug: dimethyl fumarate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annualized Relapse Rate

    Measured: 12 months

Secondary outcomes (10)

  1. Change in 14-item Treatment Satisfaction Questionnaire for Medication (TSQM-14) scores.

    TSQM-14 is an instrument to assess patient's satisfaction with medication, providing scores on four scales: Side effects, effectiveness, convenience and global satisfaction.

    Measured: Baseline to 12 months

  2. Change in Short-Form 36 (SF-36) scores.

    SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health.

    Measured: Baseline to 12 months

  3. Change in Modified Fatigue Impact Scale (MFIS-5) scores.

    MFIS-5 is a modified form of the Fatigue Impact Scale that consists of five questions that assess the impact of fatigue on physical, cognitive, and psychosocial functioning, with five response levels ranging from 0 ("Never") to 4 ("Almost always"). Total scores range from 0 to 20, with higher scores representing a greater impact of fatigue.

    Measured: Baseline to 12 months

  4. Change in Beck Depression Inventory (BDI-7) scores.

    BDI-7 is a self-report inventory for measuring the severity of depression on a 7-item scale.

    Measured: Baseline to 12 months

  5. Change in Work Productivity and Impairment Questionnaire: Multiple Sclerosis (WPAI-MS) scores.

    The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.

    Measured: Baseline to 12 months

  6. Change in Morisky 8-item Medication Adherence Scale (MMAS-8) scores.

    MMAS-8 is a self-reporting tool to facilitate the identification of barriers to and behaviors associated with adherence to chronic medications. Scores on the MMAS-8 range from 0-8, with scores of less than 6 reflecting low adherence.

    Measured: Baseline to 12 months

  7. Change in Patient-reported Expanded Disability Status Scale (patient-reported EDSS) scores.

    The patient-reported EDSS measures disability status based on patient report of degree of difficulty in eight different functional areas (on a 4-point scale), and overall function, taking into account the eight areas and descriptions of gait.

    Measured: Baseline to 12 months

  8. Proportion of patients experiencing a relapse.

    Measured: Baseline to 12 months

  9. Proportion of patients with relapses associated with hospitalizations.

    Measured: Baseline to 12 months

  10. Proportion of patients with relapses associated with steroid use.

    Measured: Baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
333 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01903291
Sponsor's protocol ID
109MS404
Acronym
RESPOND
Status last verified
Jul 2016
First submitted
17 Jul 2013
Last updated
25 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • Repovic P, Robertson D, Kresa-Reahl K, Cohan SL, Su R, Avila R, Koulinska I, Mendoza JP. Effectiveness of Dimethyl Fumarate in Patients With Relapsing Multiple Sclerosis Switching After Suboptimal Response to Glatiramer Acetate, Including Patients With Early Multiple Sclerosis: Subgroup Analysis of RESPOND. Neurol Ther. 2021 Jun;10(1):169-182. doi: 10.1007/s40120-020-00223-2. Epub 2020 Nov 23.

    PubMed 33225410

  • Kresa-Reahl K, Repovic P, Robertson D, Okwuokenye M, Meltzer L, Mendoza JP. Effectiveness of Delayed-release Dimethyl Fumarate on Clinical and Patient-reported Outcomes in Patients With Relapsing Multiple Sclerosis Switching From Glatiramer Acetate: RESPOND, a Prospective Observational Study. Clin Ther. 2018 Dec;40(12):2077-2087. doi: 10.1016/j.clinthera.2018.10.011. Epub 2018 Nov 22.

    PubMed 30470580

Questions about this trial

What is this clinical trial studying?

An observational study of Relapsing Forms of Multiple Sclerosis, run by Biogen at 62 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized Relapse Rate (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01903291, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2016.

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