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临床试验/NCT03073603
NCT03073603已完成4 期

Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS)

University of Colorado, Denver19 个研究点 分布在 1 个国家目标入组 259 人开始时间: 2017年4月20日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
259
试验地点
19
主要终点
Number of Participants Developing a New MS Relapse and/or MRI Brain Lesion Over the Course of the Study Duration
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Natural history research in Multiple Sclerosis (MS) suggests that risk of relapses and new Magnetic Resonance Imaging (MRI) changes diminish significantly as people age, especially in MS patients 55 or older. Thus, the need to continue MS medicines that reduce relapses and new MRI lesions may also decrease as people age, especially in those who have not had relapses or MRI scan changes for prolonged times. This study plans to learn more about the safety of stopping MS medication in this population, as compared to continuing on the medication.

详细描述

Participants will be randomized (1:1) to one of two groups. One group will stay on their current MS medication (Continue group), and one group will discontinue their medication (Discontinue group). They will also have some extra assessments done at their regular routine MS clinic appointment and every 6 months for the next 18-24 months. The following items will be done in addition to any assessments or procedures they are already having done as part of their clinical care:

  • Questionnaires about the participant's quality of life including questions about health, mood, thinking, and social life
  • Questionnaires about the participant's MS symptoms
  • Test of the participant's attention, concentration, and thinking
  • Test of the participant's physical symptoms
  • In addition to any MRIs the participants may get as part of their routine care, they will also have an MRI 6 months from their enrollment into the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
55 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Patients with either Relapsing-remitting MS (RRMS), Secondary progressive MS (SPMS), or Primary progressive MS (PPMS) by McDonald 2010 criteria.
  • •Patients defined by subtype based on 2013 updated phenotypic criteria.
  • •Progression of MS defined by the local PI either:
  • •prospectively with an EDSS change of at least 1.0 points over the last two years, or
  • •retrospectively, with any significant change in motor function over at least one year, unrelated to relapse.
  • •55 years of age or older at time of randomization;
  • •No evidence of recent new inflammatory disease activity (inactive by the Lublin criteria16) with no new relapse for at least five years and no new MRI lesion for at least three years
  • •Using any of the FDA-approved MS DMTs (to include:
  • •interferon β-1a,
  • •interferon β-1b,
  • •glatiramer acetate,
  • •natalizumab,
  • •fingolimod,
  • •dimethyl fumarate,
  • •ocrelizumab, or
  • •teriflunomide; continuously for no less than 5 years.
  • •Taking most recent DMT continuously* for no less than two years.
  • •Willing to be randomized per this protocol; each patient will be questioned as to their willingness to stay in the trial regardless of the group to which group they are randomized.
  • •Willing to follow the protocol
  • •Able to undergo a brain MRI without anesthesia
  • •Continuously will be defined as no less than 75% of all prescribed doses, with no time of greater than four weeks from last intended dose to have missed a dose (8 weeks for natalizumab, i.e. one missed dose).

排除标准

  • •Any MS relapse in the last five years, as determined at the screen visit by the PI
  • •Any new or definitely enlarging T2/FLAIR lesion or new gadolinium-enhancing lesion within the past three years (at least two scans separated by at least three years must be reviewed) on brain or spine MRI scan. Lesions must be 3mm or larger to be exclusionary.
  • •Significant (as defined by the PI) intolerance of presently-used DMT
  • •More than two courses of acute, systemic (IV or oral) steroids in the last 5 years or any use within the last year. Course is defined as three or more days continuously, and not to exceed 14 days. No use of chronic, systemic steroids, defined as 15 or more days, in the last 5 years. Any use of steroids to treat MS relapse, possible relapse, or pseudo-relapse in the last 5 years.
  • •Use of inhaled or topical steroids are not an exclusion criteria.
  • •Use of oral steroids for no greater than 14 days given for a non-MS condition is not exclusionary.
  • •Prior use of the following in the past 5 years:
  • •alemtuzumab,
  • •mitoxantrone,
  • •cyclophosphamide,
  • •methotrexate,
  • •cyclosporine,
  • •rituximab,
  • •siponimod, or
  • •cladribine
  • •Prior use of any experimental agent used as a DMT for MS in the last five years
  • •Other significant medical or psychiatric illness, if uncontrolled. Examples:
  • •uncontrolled hypertension,
  • •uncontrolled diabetes,
  • •uncontrolled asthma, or
  • •uncontrolled depression
  • •Cancers other than basal cell skin cancers within the last 5 years
  • •Unable to give informed consent or follow the protocol
  • •Unable to undergo brain MRI
  • •Unwilling to be randomized per this protocol
  • •History of other chronic neurological illnesses that might mimic MS with chronic or intermittent symptoms (i.e. ALS, myasthenia gravis, chronic neuropathy, etc.)

研究组 & 干预措施

Drug Continuation Arm

Active Comparator

Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease.

干预措施: Standard of Care (Drug)

Drug Discontinuation Arm

Experimental

Participants who will discontinue their Disease Modifying Therapies (DMTs). No other changes to their treatment occur. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease.

干预措施: Discontinuation of disease modifying therapy (Drug)

结局指标

主要结局

Number of Participants Developing a New MS Relapse and/or MRI Brain Lesion Over the Course of the Study Duration

时间窗: 18-24 months, based on time of enrollment

The outcome is the proportion of participants in each group developing a new MS relapse and/or MRI brain lesion over the course of the study duration. Count of Participants with either a new MS relapse and/or a new brain MRI lesion is reported.

次要结局

  • Change in Neuro-QoL (Quality of Life) Short Form Scores -- Ability to Participate in Social Roles and Activities(Baseline, 18-24 Months, based on time of enrollment)
  • Change in SymptoMScreen Composite Score (SymptoMScreen - Overall Symptom Severity).(Baseline, then every 6 months for up to a maximum of 24 months, based on time of enrollment. The change between baseline and Month 18-24 is reported.)
  • Change in Neuro-QoL (Quality of Life) Short Form Scores -- Lower Extremity Function(Baseline, 18-24 Months, based on time of enrollment)
  • Change in Neuro-QoL (Quality of Life) Short Form Scores -- Upper Extremity Function(Baseline, 18-24 Months, based on time of enrollment)
  • Change in Patient-Determined Disease Steps (PDDS - Disability).(Baseline, then every 6 months for up to a maximum of 24 months, based on time of enrollment. The change between baseline and Month 18-24 is reported.)
  • Number With Disability Progression Confirmed at 6 Months Using the Expanded Disability Status Scale (EDSS)(Baseline, then every 6 months for up to a maximum of 24 months, based on time of enrollment.)
  • Change in Neuro-QoL (Quality of Life) Short Form Scores -- Fatigue(Baseline, 18-24 Months, based on time of enrollment)
  • Change in Neuro-QoL (Quality of Life) Short Form Scores -- Sleep Disturbance(Baseline, 18-24 Months, based on time of enrollment)
  • Change in Neuro-QoL (Quality of Life) Short Form Scores -- General Concerns(Baseline, 18-24 Months, based on time of enrollment)
  • Change in Neuro-QoL (Quality of Life) Short Form Scores -- Executive Function(Baseline, 18-24 Months, based on time of enrollment)
  • Change in Neuro-QoL (Quality of Life) Short Form Scores -- Communication(Baseline, 18-24 Months, based on time of enrollment)
  • Change in Neuro-QoL (Quality of Life) Short Form Scores -- Anxiety(Baseline, 18-24 Months, based on time of enrollment)
  • Change in Neuro-QoL (Quality of Life) Short Form Scores -- Depression(Baseline, 18-24 Months, based on time of enrollment)
  • Change in Neuro-QoL (Quality of Life) Short Form Scores -- Positive Affect and Well-Being(Baseline, 18-24 Months, based on time of enrollment)
  • Change in Neuro-QoL (Quality of Life) Short Form Scores -- Emotional-Behavioral Dyscontrol(Baseline, 18-24 Months, based on time of enrollment)
  • Change in Neuro-QoL (Quality of Life) Short Form Scores -- Satisfaction With Social Roles and Activities(Baseline, 18-24 Months, based on time of enrollment)
  • Change in Symbol Digit Modalities Test (SDMT - Cognition).(Baseline, then every 6 months for up to a maximum of 24 months, based on time of enrollment. The change between baseline and Month 18-24 is reported.)
  • Evaluation of the Patient's Quality of Life Using the MSIS-29 Scale -- Physical Impact(Baseline, then every 6 months for up to a maximum of 24 months, based on time of enrollment. The change between baseline and Month 18-24 is reported.)
  • Evaluation of the Patient's Quality of Life Using the MSIS-29 Scale -- Psychological Impact(Baseline, then every 6 months for up to a maximum of 24 months, based on time of enrollment. The change between baseline and Month 18-24 is reported.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (19)

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