Overview

This trial is active, not recruiting.

Conditions rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, crohn's disease, psoriasis chronic
Treatments innovator infliximab, biosimilar infliximab
Phase phase 4
Target TNF-alpha
Sponsor Diakonhjemmet Hospital
Collaborator South-Eastern Norway Regional Health Authority
Start date October 2014
End date June 2016
Trial size 482 participants
Trial identifier NCT02148640, 2014-002056-40, DIA2014-01

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Infusions of biosimilar infliximab (Remsima) with same dose and frequency as pre-inclusion treatment with innovator infliximab (Remicade)
biosimilar infliximab Remsima
(Active Comparator)
Continued infusions of innovator infliximab (Remicade) with same dose and frequency as prior to inclusion
innovator infliximab Remicade

Primary Outcomes

Measure
Occurrence of disease worsening
time frame: 52 weeks

Secondary Outcomes

Measure
Time to disease worsening
time frame: 52 weeks
Occurrence of study drug discontinuation
time frame: 52 weeks
Time to 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
Inflammation laboratory parameters
time frame: 52 weeks
Remission status according to DAS28
time frame: 52 weeks
Disease activity according to DAS28
time frame: 52 weeks
Remission status according to CDAI
time frame: 52 weeks
Disease activity according to CDAI
time frame: 52 weeks
Remission status according to SDAI
time frame: 52 weeks
Disease activity according to SDAI
time frame: 52 weeks
Remission status according to ACR/EULAR
time frame: 52 weeks
Disease activity according to ACR/EULAR
time frame: 52 weeks
Remission status according to ASDAS
time frame: 52 weeks
Disease activity according to ASDAS
time frame: 52 weeks
Remission status according to Partial Mayo Score
time frame: 52 weeks
Disease activity according to Partial Mayo Score
time frame: 52 weeks
Remission status according to Harvey-Bradshaw index
time frame: 52 weeks
Disease activity according to Harvey-Bradshaw index
time frame: 52 weeks
Remission status according to PASI
time frame: 52 weeks
Disease activity according to PASI
time frame: 52 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Tore K. Kvien, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Diakonhjemmet Hospital.