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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A02016-A00700-51 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The purpose of this study is to evaluate the effectiveness of the switch from the original infliximab ( REMICADE®) to its biosimilar (INFLECTRA®) in all the patients at Cochin hospital receiving REMICADE® for either a rheumatic, gastro-enterologic or ophthalmic condition
All patients managed in one of the departments of cochin Hospital who are receiving the original infliximab ( REMICADE®) from at least 4 months will be invited to continue to receive infliximab but using its biosimilar (INFLECTRA®)) at the same regimen (identical dose per infusion and interval between two infusions) than the previous one while receiving REMICADE®. The tolerability of the infusion will be recorded as well as the percentage of patients continuing INFLECTRA® after at least six months of its initiation.
Moreover, the infliximab serum level will be evaluated after the last infusion of REMICADE® and after the third infusion of INFLECTRA®. At the same time, anti-drug antibodies will be tested.
Finally for each of the underlying disease (e.g. rheumatoid arthritis, spondyloarthritis, Crohn's disease, uveitis,..), the maintenance of the efficacy of Infliximab will be evaluated according to the usual outcome measures of the activity of the disease
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Switch from REMICADE® to INFLECTRA® | Other | Treatment with an infliximab biosimilar (i.e. INFLECTRA® ) for all patients which have been treated by REMICADE® for at least 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients continuing INFLECTRA® | Evaluation of the percentage of patients continuing INFLECTRA® after its third infusion | after the third infusion of INFLECTRA®, up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Infliximab serum level | after the third infusion of INFLECTRA®, up to 24 weeks | |
| Percentage of patients with a flare of their disease | The flare will be assessed by usual physiological parameter of the disease |
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Inclusion Criteria:
Exclusion Criteria:
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All patients managed in one of the departments of cochin Hospital who are receiving the original infliximab ( REMICADE®) from at least 4 months
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| Name | Affiliation | Role |
|---|---|---|
| Maxime DOUGADOS, MD, PhD | Assistance Publique - Hôpitaux de Paris | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Cochin | Paris | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29102156 | Result | Avouac J, Molto A, Abitbol V, Etcheto A, Salcion A, Gutermann L, Klotz C, Elhai M, Cohen P, Soret PA, Morin F, Conort O, Chast F, Goulvestre C, Jeunne CL, Chaussade S, Kahan A, Roux C, Allanore Y, Dougados M. Systematic switch from innovator infliximab to biosimilar infliximab in inflammatory chronic diseases in daily clinical practice: The experience of Cochin University Hospital, Paris, France. Semin Arthritis Rheum. 2018 Apr;47(5):741-748. doi: 10.1016/j.semarthrit.2017.10.002. Epub 2017 Oct 5. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D025241 | Spondylarthritis |
| D003424 | Crohn Disease |
| D014605 | Uveitis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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serum
| after the third infusion of INFLECTRA®, up to 24 weeks |
| Percentage of patients with anti-drug antibodies assessed after the third infusion of INFLECTRA® | after the third infusion of INFLECTRA®, up to 24 weeks |
| Percentage of patients with anti drug antibodies assessed after the last infusion of REMICADE® | after the last infusion of REMICADE®, up to 24 weeks |
| 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 |
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |