An Open-label Extension Study of the Double-blind, Randomized, Parallel Group, Multicenter Phase 2 Study 307000A to Further Evaluate the Safety and Tolerability of Betaseron® 500 mcg Subcutaneously Every Other Day and Betaseron® 250 mcg Subcutaneously Every Other Day in Patients With Relapsing-remitting Multiple Sclerosis (RRMS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 63
- 主要终点
- Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities
研究概览
简要总结
The purpose of this study is to determine if a higher dose of study drug is more effective in preventing relapses in patients with Multiple Sclerosis.
详细描述
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.
Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated statement of informed consent
- •Completion of Protocol 307000A
- •Negative serum pregnancy test results
- •Agreement to adequate contraception, for female patients
排除标准
- •Pregnancy or lactation
- •History of alcohol or drug abuse
- •Inability to administer subcutaneous injections either by self or by caregiver
- •Medical, psychiatric or other conditions that compromise the patient's ability to give informed consent, to understand the patient information, to comply with the study protocol, or to complete the study
- •Any significant change in the patient's medical condition after enrollment in Study 307000A which would have lead to his/her exclusion from participation that study
研究组 & 干预措施
ET: IFNB-1b 250 mcg => 250 mcg
Extension Treatment 250 mcg continued
干预措施: Interferon beta 1b (Betaseron, BAY86-5046) (Drug)
ET: IFNB-1b 500 mcg => 250 mcg
Extension Treatment 500 mcg reduced to 250 mcg
干预措施: Interferon beta 1b (Betaseron, BAY86-5046) (Drug)
ET: IFNB-1b 500 mcg => 500 mcg
Extension Treatment 500 mcg continued
干预措施: Interferon beta 1b (Betaseron, BAY86-5046) (Drug)
ET: IFNB-1b 250 mcg => 500 mcg
Extension Treatment 250 mcg increased to 500 mcg
干预措施: Interferon beta 1b (Betaseron, BAY86-5046) (Drug)
结局指标
主要结局
Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities
时间窗: At End of Study Visit (week 234)
Outcome measures are given as the number of patients with common toxicity by the Common Toxicity Criteria (CTC). Toxicity grading is: Grade 1: no study drug action recommended, Grade 2: Dose reduction or interruption of study treatment should be considered (grade 2 Lymphocyte toxicity required no study drug action), Grade 3: Dose reduction or interruption should be considered; interruption is recommended, and Grade 4: Interruption of study drug is recommended (Grade 4 laboratory toxicity was reported as a serious adverse event). Liver and bone marrow abnormalities are measured by lab tests.
次要结局
- Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b(At End of Study Visit (week 234))