A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN'S DISEASE AND CHRONIC PLAQUE PSORIASIS THE NOR-SWITCH STUDY
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 482
- 试验地点
- 26
- 主要终点
- Occurrence of disease worsening
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of switching from Remicade to the biosimilar treatment Remsima in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and chronic plaque psoriasis
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •A clinical diagnosis of either rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease or chronic plaque psoriasis
- •Male or non-pregnant, non-nursing female
- •>18 years of age at screening
- •Stable treatment with innovator infliximab (Remicade) during the last 6 months
- •Subject capable of understanding and signing an informed consent form
- •Provision of written informed consent
排除标准
- •Major co-morbidities, such as severe malignancies, severe diabetic mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease (NYHA class 3 or 4) and/or severe respiratory diseases
- •Change of major co-medication during the last 2 months prior to randomization:
- •RA, SpA and PsA: Initiation of systemic corticosteroids or synthetic DMARDs or other medication which according to the investigator would interfere with the stability of the disease.
- •UC and CD: Initiation of systemic corticosteroids or an immunosuppressant or other medication which according to the investigator would interfere with the stability of the disease Psoriasis: Initiation of synthetic DMARDs or other medication which according to the investigator would interfere with the stability of the disease
- •Inadequate birth control, pregnancy, and/or breastfeeding
- •Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible
- •Change in treatment with innovator infliximab (Remicade) during the last 6 months due to disease related factors, not including dose/frequency adjustments due to drug concentration measurements
研究组 & 干预措施
CT-P13
Infusions of biosimilar infliximab (Remsima) with same dose and frequency as pre-inclusion treatment with innovator infliximab (Remicade)
干预措施: Biosimilar infliximab (Drug)
INX
Continued infusions of innovator infliximab (Remicade) with same dose and frequency as prior to inclusion
干预措施: Innovator infliximab (Drug)
结局指标
主要结局
Occurrence of disease worsening
时间窗: 52 weeks
A disease worsening in RA and PsA is defined as an increase in DAS28 of ≥ 1.2 from randomization and a minimum DAS score of 3.2. A disease worsening in AS/SpA is defined as an increase in ASDAS of ≥1.1 from randomization and a minimum ASDAS of 2.1. A disease worsening in ulcerative colitis is defined as an increase in Partial Mayo score of ≥ 3 points from randomization and a minimum partial Mayo score of ≥ 5 points. A disease worsening in Crohn's disease is defined as an increase in HBI of ≥ 4 points from randomization and a minimum HBI score of 7 points. A disease worsening in psoriasis is defined as an increase in PASI of ≥ 3 points from randomization and a minimum PASI score of 5. If a patient does not fulfill the formal definition, but experiences a clinically significant worsening according to both the investigator and patient and which leads to a major change in treatment this should be considered as a disease worsening but recorded separately in the CRF.
次要结局
- Physicians's global assessment of disease activity(52 weeks)
- Remission status according to DAS28(52 weeks)
- Disease activity according to SDAI(52 weeks)
- Time to study drug discontinuation(52 weeks)
- Inflammation laboratory parameters(52 weeks)
- Disease activity according to DAS28(52 weeks)
- Remission status according to CDAI(52 weeks)
- Disease activity according to CDAI(52 weeks)
- Occurrence of study drug discontinuation(52 weeks)
- Patient's global assessment of disease activity(52 weeks)
- Remission status according to ACR/EULAR(52 weeks)
- Time to disease worsening(52 weeks)
- Disease activity according to ASDAS(52 weeks)
- Remission status according to Harvey-Bradshaw index(52 weeks)
- Disease activity according to Harvey-Bradshaw index(52 weeks)
- Disease activity according to PASI(52 weeks)
- Remission status according to SDAI(52 weeks)
- Disease activity according to ACR/EULAR(52 weeks)
- Remission status according to Partial Mayo Score(52 weeks)
- Remission status according to ASDAS(52 weeks)
- Disease activity according to Partial Mayo Score(52 weeks)
- Remission status according to PASI(52 weeks)
研究者
Tore K Kvien
Prof. Dr. Med.
Diakonhjemmet Hospital