A Prospective Observational Registry of H.P. Acthar® Gel for the Treatment of Multiple Sclerosis Relapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mallinckrodt
- 入组人数
- 160
- 试验地点
- 38
- 主要终点
- Physical subscale score of the Multiple Sclerosis Impact Scale, v.1 (MSIS-29v1)
研究概览
简要总结
Acthar Gel was first approved by the Food and Drug Administration in 1952.
It has been used to treat many different illnesses, including multiple sclerosis.
This study will observe how treatment with Acthar affected the daily lives of patients who suffer with relapsing/remitting MS.
It will collect information on symptoms, recovery, treatment patterns and safety outcomes.
详细描述
Acthar Gel (repository corticotropin injection) contains a non-bovine analogue of adrenocorticotropic hormone (ACTH) for intramuscular or subcutaneous use.
It was initially approved by the FDA in 1952 and is used for multiple indications.
This registry will evaluate the use of Acthar Gel for the treatment of MS exacerbations in the United States.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female ≥ 18 years of age.
- •Patient has a clinically definite relapsing form of Multiple Sclerosis according to McDonald Criteria (2010 revision).
- •Patient with an acute MS exacerbation as determined by their treating clinician.
- •Patient planning to initiate Acthar Gel for the treatment of an acute MS exacerbation.
- •Patient capable of providing informed consent.
排除标准
- •Patients with a diagnosis of Progressive MS.
- •Patients that require concomitant corticosteroid therapy.
- •Patients receiving experimental drug therapy.
- •Patients with a history of scleroderma, systemic fungal infections, ocular herpes simplex within prior 5 years.
- •Patient has any solid tumor malignancy currently diagnosed or undergoing therapy, or has received therapy for any solid tumor malignancy in the 5 years prior to the Enrollment Visit, with the exception of treated and cured basal cell carcinoma, treated and cured squamous cell carcinoma of the skin, and treated and cured carcinoma in situ of the cervix.
- •Patients who had recent surgery or have a history of or the presence of a peptic ulcer within 6 months prior to study entry, congestive heart failure, or sensitivity to proteins of porcine origin.
- •If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use appropriate birth control.
结局指标
主要结局
Physical subscale score of the Multiple Sclerosis Impact Scale, v.1 (MSIS-29v1)
时间窗: at 2 months
Participants rate 20 physical symptoms of multiple sclerosis (MS) on a scale from 1=not at all to 5=extremely. The highest possible score is 100. Higher scores mean physical symptoms of MS have a higher impact on day-to-day life. For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).
次要结局
- Physical subscale score of the MSIS-29v1 within 6 months(within 6 months)
- Psychological subscale score of the MSIS-29v1 within 6 months(within 6 months)
- Score on the Expanded Disability Status Scale/Functional System Score (EDSS/FSS)(within 6 months)
- Clinical Global Impression of Improvement Scale (CGI-I)(within 6 months)
- Total score of the MSIS-29v1 within 6 months(within 6 months)
- Number of participants with treatment response based on the MSIS-29v1 physical subscale score(within 6 months)
- Number of participants with treatment response based on the EDSS(within 6 months)
- Percent of normal work hours missed (absenteeism) due to MS exacerbation(within 6 months)
- Number of participants with impairment at work and/or reduced on-the-job effectiveness (presenteeism) due to MS exacerbation(within 6 months)
- Number of participants with overall Impairment at Work (absenteeism + presenteeism) due to MS exacerbation(within 6 months)
- Number of days per month an unpaid caregiver missed work due to the patient's MS(within 6 months)
- Number of participants with Impairment in activities other than work due to MS exacerbation(within 6 months)
- Number of MS-related emergency department visits(within 6 months)
- Number of MS-related off-site clinical/office visits with a specialist or a general practitioner(within 6 months)
- Number of MS-related healthcare professional visits at home(within 6 months)
- Number of days per month of MS-related paid and unpaid caregiver assistance(within 6 months)
- Number of MS-related hospitalizations(within 6 months)
- Number of MS-related MRIs(within 6 months)