Rheumatoid Arthritis Clinical Trial
— NOR-SWITCHOfficial 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
Verified date | September 2017 |
Source | Diakonhjemmet Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Diakonhjemmet Hospital | South-Eastern Norway Regional Health Authority |
Norway,
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 |
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