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This is an observational, prospective cohort study to evaluate the safety of Remsima® SC in the treatment of RA, AS, PsA and Ps.
CT-P13(Remsima®) is an IgG1 chimeric human-murine mAb biosimilar to Remicade® (infliximab, Janssen Biologics B.V.) developed by CELLTRION, Inc.The purpose of this study is to assess the safety of Remsima® Subcutaneous (SC) in Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA) and Psoriasis (Ps) patients by evaluation of adverse events of special interest (AESI)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P13 SC for RA patients | Patient will be treated as per the SmPC. The enrolled patient with RA will be administered Remsima® SC on the enrolment date and Remsima® SC injections will be continued according to the local standard of care. Study assessment will be done at least every 3 months through outpatient visit or telephone follow-up as part of routine care practice. Each outpatient visit is recommended to be done at least every 6 months and telephone follow-up will be done every 3 months after each outpatient visit to assess the patient. |
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| CT-P13 SC for As, PsA and Ps patients | Patient will be treated as per the SmPC. The enrolled patient with AS, PsA, and Ps will be administered Remsima® SC on the enrolment date and Remsima® SC injections will be continued according to the local standard of care. Study assessment will be done at least every 3 months through outpatient visit or telephone follow-up as part of routine care practice. Each outpatient visit is recommended to be done at least every 6 months and telephone follow-up will be done every 3 months after each outpatient visit to assess the patient. |
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| CT-P13 IV for As, PsA and Ps patients | Patient will be treated as per the SmPC. The enrolled patient with AS, PsA, and Ps will be administered Remsima® IV on the enrolment date and Remsima® IV infusions will be continued according to the local standard of care. Study assessment will be done at least every 3 months through outpatient visit or telephone follow-up as part of routine care practice. Each outpatient visit is recommended to be done at least every 6 months and telephone follow-up will be done every 3 months after each outpatient visit to assess the patient. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remsima IV | Drug | Patient will be treated with Remsima IV as per the SmPC or |
|
| Measure | Description | Time Frame |
|---|---|---|
| evaluation of adverse events of special interest (AESI) | The safety population will consist of all patients who receive at least 1 (full or partial) dose of either Remsima® SC or Remsima® IV during study period. Analyses will be performed on the observed cases. All safety data will be summarized by treatment groups as appropriate in the Safety population. | through study completion, an average of 2 years |
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Inclusion Criteria:
a.Patients with active RA having inadequate response to disease modifying antirheumatic drugs (DMARDs), including methotrexate (MTX) or b.Patients with severe, active and progressive RA not previously treated with MTX or other DMARDs c.Patients with severe, active AS who have responded inadequately to conventional therapy or d.Patients with active and progressive PsA when the response to previous DMARDs has been inadequate or e.Patients with moderate to severe plaque Ps who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A.
The Remsima® SC group will include all patients who meet one of the following classification at the time of enrolment:
The Remsima® IV group will include all patients who meet one of the following classification at the time of enrolment:
Exclusion Criteria:
Patients with a history of hypersensitivity to murine, chimeric, human, or humanized proteins or any of the excipients of Remsima® SC or Remsima® IV, whichever the patients are going to be treated in each treatment group, listed in the Summary of Product Characteristics (SmPC) of each product.
Patients with any reported contraindications for Remsima® SC or Remsima® IV according to the SmPC of each product.
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Male or female patients with RA will be enrolled and treated with Remsima® SC. Male or female patients with AS, PsA, and Ps will be enrolled and treated with either Remsima® SC or Remsima® IV. Patients will be considered for enrolment in the study if they meet all of the inclusion criteria and none of the exclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Purpan Hôpital Pierre Paul Riquet | Toulouse | France | 31059 | France |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D013167 | Spondylitis, Ankylosing |
| D015535 | Arthritis, Psoriatic |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Remsima SC | Drug | Patient will be treated with Remsima SC as per the SmPC |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D000844 | Ankylosis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |