The NOR-SWITCH Study
NCT02148640 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 482
Last updated 2017-09-25
Summary
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
Conditions
- Rheumatoid Arthritis
- Spondyloarthritis
- Psoriatic Arthritis
- Ulcerative Colitis
- Crohn's Disease
- Psoriasis Chronic
Interventions
- DRUG
-
Innovator infliximab
- DRUG
-
Biosimilar infliximab
Sponsors & Collaborators
-
South-Eastern Norway Regional Health Authority
collaborator OTHER -
Diakonhjemmet Hospital
lead OTHER
Principal Investigators
-
Tore K. Kvien, MD PhD · Diakonhjemmet Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-10-31
- Primary Completion
- 2016-06-30
- Completion
- 2017-01-31
Countries
- Norway
Study Locations
More Related Trials
-
RESTART C0168Z05 Rheumatoid Arthritis Study
NCT00714493 ·Status: COMPLETED ·Phase: PHASE4
-
A Phase 3 Study of NI-071 in Participants With Rheumatoid Arthritis (RADIANCE)
NCT02990806 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety Study of Infliximab (Remicade) to Treat Early Ankylosing Spondylitis
NCT00936143 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis (RENOIR)
NCT06041269 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
NCT01936181 ·Status: COMPLETED ·Phase: PHASE3
-
Rheumatic IMmune-Related Adverse Events in Patients Treated With Immune Check Point Inhibitors
NCT05544292 ·Status: COMPLETED
-
An Observational Study of Infliximab in Participants Suffering From Ankylosing Spondylitis With Hip Involvement
NCT02293681 ·Status: TERMINATED
-
Comparison of Adalimumab and Infliximab Treatment of Rheumatoid Arthritis
NCT00216177 ·Status: UNKNOWN ·Phase: PHASE4
-
A Study of Infliximab (Remicade) in Patients With Ankylosing Spondylitis.
NCT00207701 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis
NCT03120949 ·Status: COMPLETED ·Phase: PHASE3
-
Growth Factor Concentration to Predict an Ankylosing Spondylitis Patient's Response to Infliximab (Study P04041)(COMPLETED)
NCT00779935 ·Status: COMPLETED ·Phase: PHASE4
-
Comparative and Pragmatic Study of Golimumab Intravenous (IV) (Simponi Aria) Versus Infliximab (Remicade) in Rheumatoid Arthritis
NCT02728934 ·Status: COMPLETED
-
Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan
NCT03348046 ·Status: COMPLETED
-
A Safety and Efficacy Study for Infliximab (Remicade) With Methotrexate in Patients With Early Rheumatoid Arthritis
NCT00236028 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of the Safety and PK of SYN060 to Humira® in Healthy Adult Subjects
NCT03254810 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Rheumatoid Arthritis.
NCT00036387 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis
NCT06028438 ·Status: COMPLETED ·Phase: PHASE2
-
bIosimilar of aDalimumab, an European evAluation
NCT05190484 ·Status: UNKNOWN
-
A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
NCT02046616 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
NCT06570798 ·Status: RECRUITING ·Phase: PHASE2
-
A 12-month Real Life Study of IBD Patients Switched From Adalimumab Originator Humira® to One of Its Biosimilar
NCT04422171 ·Status: UNKNOWN
-
Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade
NCT02605642 ·Status: COMPLETED
-
Anti-Biopharmaceutical Immunization: Prediction and Analysis of Clinical Relevance to Minimize the Risk of Immunization in Rheumatoid Arthritis Patients or Juvenile Idiopathic Arthritis Patients
NCT02116504 ·Status: UNKNOWN ·Phase: NA
-
Pharmaco Kinetic Variability of Infliximab in Rheumatoid Arthritis
NCT00840957 ·Status: COMPLETED
-
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis
NCT01245439 ·Status: COMPLETED ·Phase: PHASE3