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 DISEASEAND CHRONIC PLAQUE PSORIASISTHE NOR-SWITCH STUDY - NOR_SWITCH

Diakonhjemmet Hospital AS0 个研究点目标入组 498 人开始时间: 2014年6月13日最近更新: 2022年4月19日

试验速览

暂无简介。

•1.A clinical diagnosis of either rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease or chronic plaque psoriasis
•2.Male or non-pregnant, non-nursing female
•3.>18 years of age at screening
•4.Stable treatment with innovator infliximab (Remicade) during the last 6 months
•5.Subject capable of understanding and signing an informed consent form
•6.Provision of written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 400
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•1.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
•2.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
•3.Inadequate birth control, pregnancy, and/or breastfeeding
•4.Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible
•5.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
•6.For patients with UC and CD: Functional colostomy or ileostomy. Extensive colonic resection with less than 25 cm of the colon left in situ.

发起方

Diakonhjemmet Hospital AS