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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002056-40 | EudraCT Number |
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| Name | Class |
|---|---|
| South-Eastern Norway Regional Health Authority | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P13 | Experimental | Infusions of biosimilar infliximab (Remsima) with same dose and frequency as pre-inclusion treatment with innovator infliximab (Remicade) |
|
| INX | Active Comparator | Continued infusions of innovator infliximab (Remicade) with same dose and frequency as prior to inclusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Innovator infliximab | Drug |
|
| |
| Biosimilar infliximab |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to disease worsening | 52 weeks | |
| Occurrence of study drug discontinuation | 52 weeks | |
| Time to study drug discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| RAND SF-36 | 52 weeks | |
| Modified Health Assessment Questionnaire (MHAQ) | Only RA, SpA and PsA patients | 52 weeks |
Inclusion Criteria:
Exclusion Criteria:
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
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
Inadequate birth control, pregnancy, and/or breastfeeding
Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible
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
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| Name | Affiliation | Role |
|---|---|---|
| Tore K. Kvien, MD PhD | Diakonhjemmet Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sørlandet Sykehus HF | Arendal | Norway | ||||
| Ålesund Sjukehus, Helse Møre og Romsdal HF |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32965617 | Derived | Jorgensen KK, Goll GL, Sexton J, Bolstad N, Olsen IC, Asak O, Berset IP, Blomgren IM, Dvergsnes K, Florholmen J, Frigstad SO, Henriksen M, Hagfors J, Huppertz-Hauss G, Haavardsholm EA, Klaasen RA, Moum B, Noraberg G, Prestegard U, Rydning JH, Sagatun L, Seeberg KA, Torp R, Vold C, Warren DJ, Ystrom CM, Lundin KEA, Kvien T, Jahnsen J. Efficacy and Safety of CT-P13 in Inflammatory Bowel Disease after Switching from Originator Infliximab: Exploratory Analyses from the NOR-SWITCH Main and Extension Trials. BioDrugs. 2020 Oct;34(5):681-694. doi: 10.1007/s40259-020-00438-7. | |
| 30762274 |
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| Drug |
|
|
| 52 weeks |
| Patient's global assessment of disease activity | 52 weeks |
| Physicians's global assessment of disease activity | 52 weeks |
| Inflammation laboratory parameters | ESR and CRP for all patients, Calprotectin for UC and CD patients | 52 weeks |
| Remission status according to DAS28 | For RA and PsA patients | 52 weeks |
| Disease activity according to DAS28 | For RA and PsA patients | 52 weeks |
| Remission status according to CDAI | For RA and PsA patients | 52 weeks |
| Disease activity according to CDAI | For RA and PsA patients | 52 weeks |
| Remission status according to SDAI | For RA and PsA patients | 52 weeks |
| Disease activity according to SDAI | For RA and PsA patients | 52 weeks |
| Remission status according to ACR/EULAR | For RA and PsA patients | 52 weeks |
| Disease activity according to ACR/EULAR | For RA and PsA patients | 52 weeks |
| Remission status according to ASDAS | For SpA patients | 52 weeks |
| Disease activity according to ASDAS | For SpA patients | 52 weeks |
| Remission status according to Partial Mayo Score | For UC patients | 52 weeks |
| Disease activity according to Partial Mayo Score | For UC patients | 52 weeks |
| Remission status according to Harvey-Bradshaw index | For CD patients | 52 weeks |
| Disease activity according to Harvey-Bradshaw index | For CD patients | 52 weeks |
| Remission status according to PASI | For psoriatic patients | 52 weeks |
| Disease activity according to PASI | For psoriatic patients | 52 weeks |
| Inflammatory Bowel Disease Questionnaire (IBDQ) |
Only UC and CD patients |
| 52 weeks |
| Dermatology Life Quality Index (DLQI) | Only Ps patients | 52 weeks |
| EQ-5D | 52 weeks |
| RAID | Only RA patients | 52 weeks |
| PsAID | Only PsA patients | 52 weeks |
| WPAI:GH | Work Productivity and Activity Impairment Questionnaire: General health | 52 weeks |
| Safety and tolerability: AEs, laboratory parameters | through study completion, an average of 52 weeks |
| Ålesund |
| Norway |
| Haukeland Universitetssjukehus Hf | Bergen | Norway |
| Haukeland Universitetssykehus | Bergen | Norway |
| Nordlandssykehuset | Bodø | Norway |
| Sykehuset Innlandet | Elverum | Norway |
| Sykehuset Østfold HF | Fredrikstad | Norway |
| Helse Førde Hf | Førde | 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 | 0319 | 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 |
| Universitetssykehuset i Nord-Norge | Tromsø | Norway |
| St. Olavs Hospital HF | Trondheim | Norway |
| St. Olavs Hospital | Trondheim | Norway |
| Sykehuset Vestfold | Tønsberg | Norway |
| Derived |
| Goll GL, Jorgensen KK, Sexton J, Olsen IC, Bolstad N, Haavardsholm EA, Lundin KEA, Tveit KS, Lorentzen M, Berset IP, Fevang BTS, Kalstad S, Ryggen K, Warren DJ, Klaasen RA, Asak O, Baigh S, Blomgren IM, Brenna O, Bruun TJ, Dvergsnes K, Frigstad SO, Hansen IM, Hatten ISH, Huppertz-Hauss G, Henriksen M, Hoie SS, Krogh J, Midtgard IP, Mielnik P, Moum B, Noraberg G, Poyan A, Prestegard U, Rashid HU, Strand EK, Skjetne K, Seeberg KA, Torp R, Ystrom CM, Vold C, Zettel CC, Waksvik K, Gulbrandsen B, Hagfors J, Mork C, Jahnsen J, Kvien TK. Long-term efficacy and safety of biosimilar infliximab (CT-P13) after switching from originator infliximab: open-label extension of the NOR-SWITCH trial. J Intern Med. 2019 Jun;285(6):653-669. doi: 10.1111/joim.12880. Epub 2019 Apr 12. |
| 28502609 | Derived | Jorgensen KK, Olsen IC, Goll GL, Lorentzen M, Bolstad N, Haavardsholm EA, Lundin KEA, Mork C, Jahnsen J, Kvien TK; NOR-SWITCH study group. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet. 2017 Jun 10;389(10086):2304-2316. doi: 10.1016/S0140-6736(17)30068-5. Epub 2017 May 11. |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D025241 | Spondylarthritis |
| D015535 | Arthritis, Psoriatic |
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D025242 | Spondylarthropathies |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| C000591237 | CT-P13 |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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