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Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade

NCT02605642 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 351

Last updated 2020-01-13

Study results available
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Summary

To assess persistence of CT-P13 in patients with Rheumatoid Diseases (Rheumatoid arthritis \[RA\], ankylosing spondylitis \[AS\], and psoriatic arthritis \[PsA\]) who are naïve to biologics or are switching from stable Remicade to CT-P13. The main objectives of the study are:

* To evaluate real-life drug persistence in RA, AS, and PsA patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade
* To characterise the patient populations and drug usage patterns of RA, AS, and PsA patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade
* To assess the safety of CT-P13 in RA, AS, and PsA patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade for up to 2 years

Conditions

Interventions

DRUG

CT-P13

biosimilar infliximab

Sponsors & Collaborators

  • Hospira, now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-10
Primary Completion
2018-12-31
Completion
2018-12-31
FDA Drug
Yes

Countries

  • Bulgaria
  • Canada
  • Czechia
  • Germany
  • Greece
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02605642 on ClinicalTrials.gov