An Observational, Prospective Cohort Study to Evaluate Safety of Remsima® Subcutaneous in Patients With Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Psoriasis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

This is an observational, prospective cohort study to evaluate the safety of Remsima® SC in the treatment of RA, AS, PsA and Ps.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ 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:

‣ Biologic-naïve patients or

⁃ Patients continuing on infliximab IV including Remsima® IV who will switch to Remsima® SC or

⁃ Patients continuing on biologic treatments other than infliximab who will switch to Remsima® SC or

⁃ Patients continuing on Remsima® SC (having commenced Remsima® SC treatment prior to enrolment)

• The Remsima® IV group will include all patients who meet one of the following classification at the time of enrolment:

‣ Biologic-naïve patients or

⁃ Patients continuing on biologic treatments other than infliximab who will switch to Remsima® IV or

⁃ Patients continuing on infliximab IV including Remsima® IV who will switch to or maintain Remsima® IV \* Note: Switching from Remsima® SC to Remsima® IV is not allowed.

Locations
Other Locations
France
CHU Purpan Hôpital Pierre Paul Riquet
RECRUITING
Toulouse
Contact Information
Primary
YounJeong Choi
younjeong.choi@celltrion.com
+82 032 850 5767
Time Frame
Start Date: 2023-01-13
Estimated Completion Date: 2027-03
Participants
Target number of participants: 864
Treatments
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.
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.
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.
Sponsors
Leads: Celltrion

This content was sourced from clinicaltrials.gov

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