Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Patients With Relapsing Multiple Sclerosis Transitioning From Standard-of-care Subcutaneous Interferon Therapy to Peginterferon Beta-1a (BIIB017)
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- Biogen
- 主要终点
- Combined Counts of adverse events (AEs) of flu-like symptoms, injection site reactions or injection site reaction pain
研究概览
简要总结
The primary objective of the study is to evaluate, in participants with RMS, safety and tolerability (as defined by the frequency of adverse events [AEs] of flu-like symptoms [FLS; chills, pyrexia, myalgia, and asthenia], injection site reactions [ISRs], and injection site reaction pain [ISR-P]) over 6 months of treatment (the active comparator period) with BIIB017 125 μg subcutaneously (SC) every 2 weeks versus standard-of-care SC interferon-beta (IFN-β) therapy. Secondary objectives of this study are to assess the following measures during the first (6-month) period of the study in participants treated with BIIB017 versus standard-of-care SC IFN-β therapy: patient-reported treatment satisfaction using the following patient-reported outcome measures (PROMs): Treatment Satisfaction Questionnaire for Medication (TSQM-9), Adapted MS Treatment Concerns Questionnaire (MSTCQ), Adapted MSTCQ Side Effects Score, Pain using a visual analog scale (VAS) diary and the McGill Pain Questionnaire Short Form (SF-MPQ), the treatments' impact on RMS using the following PROMs: Multiple Sclerosis Impact Scale (MSIS-29), Modified Fatigue Impact Scale-5 Item (MFIS-5), EuroQol Group 5-Dimension 3-Level Version (EQ-5D-3L), Health-Related Productivity Questionnaire (HRPQ), Beck Depression Inventory, second edition (BDI-II), participant adherence to study treatment, clinical status as measured by the Expanded Disability Status Scale (EDSS) and relapse activity, safety and tolerability of study treatment after a change in standard-of-care SC IFN-β therapy and the immunogenicity profiles of participants changing from standard-of-care SC IFN-β to BIIB017.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a confirmed diagnosis of Relapsing Multiple Sclerosis (RMS), as defined by McDonald criteria.
- •An Expanded Disability Status Scale (EDSS) score between 0 and 5.
- •On continual treatment for ≥6 months with a single standard-of-care subcutaneous (SC) interferon beta (IFN-β) therapy, including IFN β-1b 0.25 mg SC every other day or IFN β-1a 44 μg SC 3 times weekly, and from a clinical perspective be able to continue this therapy (i.e., no significant untoward events attributed to IFN therapy that would preclude continuation of the existing IFN therapy).
- •A candidate for change to BIIB017 therapy (candidacy for therapy change is determined by the treating physician; however, it is recommended to exclude patients with high disease activity and who are candidates for escalation therapy according to local guidelines).
- •Patients who are randomized to their current standard-of-care IFN-β therapy for the first 6 months of the study must be willing to receive their treatment via the formulation provided in the study (i.e., Rebif 44 μg in a prefilled syringe or Betaferon/Betaseron 0.25 mg in single-use vials of lyophilized powder accompanied by a prefilled single-use diluent syringe).
排除标准
- •Primary progressive, secondary progressive, or progressive relapsing MS.
- •History of inadequate response to SC IFN therapy (as determined by the treating physician).
- •History of severe allergic or anaphylactic reactions or known hypersensitivity to study drug or its excipients. - Known allergy to any component of the BIIB017 formulation.
- •History of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease that would preclude participation in a clinical study.
- •History of hypersensitivity or intolerance to acetaminophen, ibuprofen, naproxen, or aspirin that would preclude use of at least one of these during the study.
- •An MS relapse that has occurred within the 50 days prior to randomization and/or lack of stabilization from a previous relapse prior to randomization.
- •Any previous treatment with BIIB
- •Treatment with other agents for MS.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Peginterferon beta-1a
Participants will receive peginterferon beta-1a, 125 µg subcutaneously once every 2 weeks during the 6-month comparator period of the study and during the 12-month extension period.
干预措施: BIIB017 (Peginterferon beta-1a) (Drug)
Interferon-β
Participants will continue to receive their standard-of-care interferon beta treatment for the first six months. During the 12-month extension period participants will switch to receive peginterferon beta-1a, 125 µg subcutaneously once every 2 weeks.
干预措施: BIIB017 (Peginterferon beta-1a) (Drug)
Interferon-β
Participants will continue to receive their standard-of-care interferon beta treatment for the first six months. During the 12-month extension period participants will switch to receive peginterferon beta-1a, 125 µg subcutaneously once every 2 weeks.
干预措施: Interferon Beta (Drug)
结局指标
主要结局
Combined Counts of adverse events (AEs) of flu-like symptoms, injection site reactions or injection site reaction pain
时间窗: 6 Months
Combined counts of AEs of flu-like symptoms (FLS) including chills, pyrexia, myalgia, and asthenia, injection site reactions (ISRs), and injection site reaction pain (ISR-P) over the first 6 months of treatment.
次要结局
- Change from Baseline in adapted Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) total score(Baseline and Week 24)
- Change from Baseline in the adapted MSTCQ Side Effects Score(Baseline and Week 24)
- Change from Baseline in mean change in VAS pain score from pre-injection to 30 minutes post-injection(Baseline (pre-injection and 30-minutes after injection) and Week 24 (pre-injection and 30 minutes after injection))
- Change from Baseline in treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication-9 Items (TSQM-9)(Baseline and Week 24)
- Percentage of participants pain-free(6 months)
- Change from Baseline in mean McGill Pain Questionnaire Short Form (SF-MPQ) VAS pain score(Baseline and Week 24)
- Change from Baseline in the Multiple Sclerosis Impact Scale-29 items (MSIS-29) score(Baseline and Week 24)
- Change from Baseline in the Modified Fatigue Impact Scale-5 Item (MFIS-5) score(Baseline and Week 24)
- Change from Baseline in the Beck Depression Inventory, second edition (BDI-II) score(Baseline and Week 24)
- Percentage of participants with changes in Clinical Status assessed using the Expanded Disability Status Scale (EDSS)(Up to 6 months)
- Adherence to study treatment measured by the treatment adherence questionnaire(6 months)
- Number of participants with IFN β-1a and IFN β-1b binding and neutralizing antibodies, and poly(ethylene glycol) (PEG)-binding antibodies(6 months)
- Change from Baseline in the EuroQol-5-dimension 3-level version (EQ-5D-3L) index(Baseline and Week 24)
- Change from Baseline in the Health-Related Productivity Questionnaire (HRPQ) score(Baseline and Week 24)
- Annualized relapse rate (ARR)(6 months)
- Percentage of participants with relapse(6 months)
- Adherence to study treatment measured by returned autoinjectors/syringes(6 months)
- Number of participants with adverse events (AEs), serious adverse events (SAEs), and discontinuations of study treatment due to an AE(6 months)