World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02148640
Date of registration: 23/05/2014
Prospective Registration: Yes
Primary sponsor: Diakonhjemmet Hospital
Public title: The NOR-SWITCH Study NOR-SWITCH
Scientific 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
Date of first enrolment: October 2014
Target sample size: 482
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02148640
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 4
Countries of recruitment
Norway
Contacts
Name:     Tore K. Kvien, MD PhD
Address: 
Telephone:
Email:
Affiliation:  Diakonhjemmet Hospital
Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Psoriasis Chronic
Psoriatic Arthritis
Rheumatoid Arthritis
Spondyloarthritis
Ulcerative Colitis
Intervention(s)
Drug: Biosimilar infliximab
Drug: Innovator infliximab
Primary Outcome(s)
Occurrence of disease worsening [Time Frame: 52 weeks]
Secondary Outcome(s)
Disease activity according to ACR/EULAR [Time Frame: 52 weeks]
Disease activity according to ASDAS [Time Frame: 52 weeks]
Disease activity according to CDAI [Time Frame: 52 weeks]
Disease activity according to DAS28 [Time Frame: 52 weeks]
Disease activity according to Harvey-Bradshaw index [Time Frame: 52 weeks]
Disease activity according to Partial Mayo Score [Time Frame: 52 weeks]
Disease activity according to PASI [Time Frame: 52 weeks]
Disease activity according to SDAI [Time Frame: 52 weeks]
Inflammation laboratory parameters [Time Frame: 52 weeks]
Occurrence of study drug discontinuation [Time Frame: 52 weeks]
Patient's global assessment of disease activity [Time Frame: 52 weeks]
Physicians's global assessment of disease activity [Time Frame: 52 weeks]
Remission status according to ACR/EULAR [Time Frame: 52 weeks]
Remission status according to ASDAS [Time Frame: 52 weeks]
Remission status according to CDAI [Time Frame: 52 weeks]
Remission status according to DAS28 [Time Frame: 52 weeks]
Remission status according to Harvey-Bradshaw index [Time Frame: 52 weeks]
Remission status according to Partial Mayo Score [Time Frame: 52 weeks]
Remission status according to PASI [Time Frame: 52 weeks]
Remission status according to SDAI [Time Frame: 52 weeks]
Time to disease worsening [Time Frame: 52 weeks]
Time to study drug discontinuation [Time Frame: 52 weeks]
Secondary ID(s)
2014-002056-40
DIA2014-01
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
South-Eastern Norway Regional Health Authority
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history