The NOR-SWITCH Study

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Rheumatoid Arthritis, Spondyloarthritis, Psoriatic Arthritis, Ulcerative Colitis, Crohn's Disease, Psoriasis Chronic

Intervention / Treatment
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* Drug: Innovator infliximab
* Drug: Biosimilar infliximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-P13<br>Infusions of biosimilar infliximab (Remsima) with same dose and frequency as pre-inclusion treatment with innovator infliximab (Remicade) | Drug: Biosimilar infliximab<br> <br> * Other names: Remsima;|
| Active Comparator: INX<br>Continued infusions of innovator infliximab (Remicade) with same dose and frequency as prior to inclusion | Drug: Innovator infliximab<br> <br> * Other names: Remicade;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of disease worsening | 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. | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease worsening |  | 52 weeks | 
| Occurrence of study drug discontinuation |  | 52 weeks | 
| Time to study drug discontinuation |  | 52 weeks | 
| Patient's global assessment of disease activity |  | 52 weeks | 
| Physicians's global assessment of disease activity |  | 52 weeks | 
| Inflammation laboratory parameters | ESR and CRP for all patients, Calprotectin for UC and CD patients | 52 weeks | 
| Remission status according to DAS28 | For RA and PsA patients | 52 weeks | 
| Disease activity according to DAS28 | For RA and PsA patients | 52 weeks | 
| Remission status according to CDAI | For RA and PsA patients | 52 weeks | 
| Disease activity according to CDAI | For RA and PsA patients | 52 weeks | 
| Remission status according to SDAI | For RA and PsA patients | 52 weeks | 
| Disease activity according to SDAI | For RA and PsA patients | 52 weeks | 
| Remission status according to ACR/EULAR | For RA and PsA patients | 52 weeks | 
| Disease activity according to ACR/EULAR | For RA and PsA patients | 52 weeks | 
| Remission status according to ASDAS | For SpA patients | 52 weeks | 
| Disease activity according to ASDAS | For SpA patients | 52 weeks | 
| Remission status according to Partial Mayo Score | For UC patients | 52 weeks | 
| Disease activity according to Partial Mayo Score | For UC patients | 52 weeks | 
| Remission status according to Harvey-Bradshaw index | For CD patients | 52 weeks | 
| Disease activity according to Harvey-Bradshaw index | For CD patients | 52 weeks | 
| Remission status according to PASI | For psoriatic patients | 52 weeks | 
| Disease activity according to PASI | For psoriatic patients | 52 weeks |