The NOR-SWITCH Study

Rheumatoid Arthritis Clinical Trial

— NOR-SWITCH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02148640
• Other study ID #: DIA2014-01
• Secondary ID: 2014-002056-40
• Status: Completed
• Phase: Phase 4
• First received: May 23, 2014
• Last updated: September 22, 2017
• Start date: October 2014
• Est. completion date: January 2017

Study information

• Verified date: September 2017
• Source: Diakonhjemmet Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 482
• Est. completion date: January 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Psoriasis
• Psoriasis Chronic
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Spondylarthritis
• Spondyloarthritis
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Innovator infliximab

• Biosimilar infliximab

Locations

Country	Name	City	State
Norway	Ålesund Sjukehus, Helse Møre og Romsdal HF	Ålesund
Norway	Sørlandet Sykehus HF	Arendal
Norway	Haukeland Universitetssjukehus Hf	Bergen
Norway	Haukeland Universitetssykehus	Bergen
Norway	Nordlandssykehuset	Bodø
Norway	Sykehuset Innlandet	Elverum
Norway	Helse Førde Hf	Førde
Norway	Sykehuset Østfold HF	Fredrikstad
Norway	Bærum Sykehus	Gjettum
Norway	Sykehuset Innlandet	Gjøvik
Norway	Sykehuset Innlandet	Hamar
Norway	Haugesund Sanitetsforenings Revmatismesykehus	Haugesund
Norway	Helse Fonna HF	Haugesund
Norway	Sørlandet Sykehus HF	Kristiansand
Norway	Helse Nord-Trøndelag	Levanger
Norway	Revmatismesykehuset Lillehammer	Lillehammer
Norway	Sykehuset Innlandet	Lillehammer
Norway	Akershus Universitetssykehus	Lørenskog
Norway	Helgelandssykehuset	Mo i Rana
Norway	Department of Rheumatology, Diakonhjemmet Hospital	Oslo
Norway	Diakonhjemmet Hospital	Oslo
Norway	Oslo Universitetssykehus, Rikshospitalet	Oslo
Norway	Oslo Universitetssykehus, Ullevål	Oslo
Norway	Martina Hansens Hospital	Sandvika
Norway	Betanien Hospital	Skien
Norway	Sykehuset Telemark HF	Skien
Norway	Sykehuset Vestfold	Tønsberg
Norway	Universitetssykehuset i Nord-Norge	Tromsø
Norway	St. Olavs Hospital	Trondheim
Norway	St. Olavs Hospital HF	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Diakonhjemmet Hospital	South-Eastern Norway Regional Health Authority

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	RAND SF-36		52 weeks
Other	Modified Health Assessment Questionnaire (MHAQ)	Only RA, SpA and PsA patients	52 weeks
Other	Inflammatory Bowel Disease Questionnaire (IBDQ)	Only UC and CD patients	52 weeks
Other	Dermatology Life Quality Index (DLQI)	Only Ps patients	52 weeks
Other	EQ-5D		52 weeks
Other	RAID	Only RA patients	52 weeks
Other	PsAID	Only PsA patients	52 weeks
Other	WPAI:GH	Work Productivity and Activity Impairment Questionnaire: General health	52 weeks
Other	Safety and tolerability: AEs, laboratory parameters		through study completion, an average of 52 weeks
Primary	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	Time to disease worsening		52 weeks
Secondary	Occurrence of study drug discontinuation		52 weeks
Secondary	Time to study drug discontinuation		52 weeks
Secondary	Patient's global assessment of disease activity		52 weeks
Secondary	Physicians's global assessment of disease activity		52 weeks
Secondary	Inflammation laboratory parameters	ESR and CRP for all patients, Calprotectin for UC and CD patients	52 weeks
Secondary	Remission status according to DAS28	For RA and PsA patients	52 weeks
Secondary	Disease activity according to DAS28	For RA and PsA patients	52 weeks
Secondary	Remission status according to CDAI	For RA and PsA patients	52 weeks
Secondary	Disease activity according to CDAI	For RA and PsA patients	52 weeks
Secondary	Remission status according to SDAI	For RA and PsA patients	52 weeks
Secondary	Disease activity according to SDAI	For RA and PsA patients	52 weeks
Secondary	Remission status according to ACR/EULAR	For RA and PsA patients	52 weeks
Secondary	Disease activity according to ACR/EULAR	For RA and PsA patients	52 weeks
Secondary	Remission status according to ASDAS	For SpA patients	52 weeks
Secondary	Disease activity according to ASDAS	For SpA patients	52 weeks
Secondary	Remission status according to Partial Mayo Score	For UC patients	52 weeks
Secondary	Disease activity according to Partial Mayo Score	For UC patients	52 weeks
Secondary	Remission status according to Harvey-Bradshaw index	For CD patients	52 weeks
Secondary	Disease activity according to Harvey-Bradshaw index	For CD patients	52 weeks
Secondary	Remission status according to PASI	For psoriatic patients	52 weeks
Secondary	Disease activity according to PASI	For psoriatic patients	52 weeks