The NOR-SWITCH Study

Phase 4

Completed

• Conditions: Psoriatic Arthritis; Psoriasis Chronic; Spondyloarthritis; Ulcerative Colitis; Rheumatoid Arthritis; Crohn's Disease
• Interventions: Drug: Biosimilar infliximab; Drug: Innovator infliximab

• Registration Number: NCT02148640
• Lead Sponsor: Diakonhjemmet Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-23
• Study First Submitted QC: 2014-05-27
• Study First Posted: 2014-05-28
• Study Start: 2014-10
• Primary Completion: 2016-06
• Study Completion: 2017-01
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-22
• Last Update Posted: 2017-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 482

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT-P13	Biosimilar infliximab	Infusions of biosimilar infliximab (Remsima) with same dose and frequency as pre-inclusion treatment with innovator infliximab (Remicade)
INX	Innovator infliximab	Continued infusions of innovator infliximab (Remicade) with same dose and frequency as prior to inclusion

Primary Outcome Measures

Name	Time	Method
Occurrence of disease worsening	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.

Secondary Outcome Measures

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

Trial Locations

Locations (26)

Sykehuset Østfold HF; 🇳🇴 Fredrikstad, Norway

Helse Fonna HF; 🇳🇴 Haugesund, Norway

St. Olavs Hospital HF; 🇳🇴 Trondheim, Norway

Oslo Universitetssykehus, Rikshospitalet; 🇳🇴 Oslo, Norway

Sykehuset Telemark HF; 🇳🇴 Skien, Norway

Sykehuset Vestfold; 🇳🇴 Tønsberg, Norway

Ålesund Sjukehus, Helse Møre og Romsdal HF; 🇳🇴 Ålesund, Norway

Haukeland Universitetssjukehus Hf; 🇳🇴 Bergen, Norway

Haukeland Universitetssykehus; 🇳🇴 Bergen, Norway

Sørlandet Sykehus HF; 🇳🇴 Kristiansand, Norway

Nordlandssykehuset; 🇳🇴 Bodø, Norway

Sykehuset Innlandet; 🇳🇴 Lillehammer, Norway

Helse Førde Hf; 🇳🇴 Førde, Norway

Bærum Sykehus; 🇳🇴 Gjettum, Norway

Haugesund Sanitetsforenings Revmatismesykehus; 🇳🇴 Haugesund, Norway

Helse Nord-Trøndelag; 🇳🇴 Levanger, Norway

Akershus Universitetssykehus; 🇳🇴 Lørenskog, Norway

Helgelandssykehuset; 🇳🇴 Mo i Rana, Norway

Revmatismesykehuset Lillehammer; 🇳🇴 Lillehammer, Norway

Department of Rheumatology, Diakonhjemmet Hospital; 🇳🇴 Oslo, Norway

Diakonhjemmet Hospital; 🇳🇴 Oslo, Norway

St. Olavs Hospital; 🇳🇴 Trondheim, Norway

Martina Hansens Hospital; 🇳🇴 Sandvika, Norway

Oslo Universitetssykehus, Ullevål; 🇳🇴 Oslo, Norway

Betanien Hospital; 🇳🇴 Skien, Norway

Universitetssykehuset i Nord-Norge; 🇳🇴 Tromsø, Norway