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Post-Marketing Use Of Inflectra (Infliximab) For Standard Of Care Treatment Of Rheumatoid Disease Who Are Naïve To Biologics Or Switched From Remicade™

Last updated on April 10, 2018

FOR MORE INFORMATION
Study Location
MHAT Trimontium OOD
Plovdiv, , 4000 Bulgaria
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Patients aged ≥18 years old at the time of enrollment

2. Patients who are prescribed Inflectra or Remicade for the treatment of rheumatoid
arthritis, ankylosing spondylitis, and psoriatic arthritis prescribed according to the
corresponding summary of product characteristics (SmPC and Product Monograph) as
determined by the investigator

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. Any reported contraindications for Inflectra according to the SmPC or Product
Monograph

2. Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its
excipients or other murine proteins, at the time of enrollment

NCT02605642
Pfizer
Active, not recruiting
Post-Marketing Use Of Inflectra (Infliximab) For Standard Of Care Treatment Of Rheumatoid Disease Who Are Naïve To Biologics Or Switched From Remicade™

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Post-Marketing Use Of Inflectra (Infliximab) For Standard Of Care Treatment Of Rheumatoid Disease Who Are Naïve To Biologics Or Switched From Remicade?
Persist: Prospective Observational Cohort Study To Assess Persistence Of Inflectra(tm) (Infliximab) In Patients With Rheumatoid Diseases Who Are Either Naive To Biologics Or Switched From Stable Remicade(tm) (Infliximab)

To assess persistence of Inflectra in patients with Rheumatoid Disease (Rheumatoid arthritis [RA], ankylosing spondylitis [AS], and psoriatic arthritis [PsA]) who are naive to biologics or are switching over from stable Remicade to Inflectra. The main objectives of the study are:

  • To evaluate real-life drug persistence in RA, AS, and PsA patients who are either initiated with Inflectra? 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 Inflectra? as their first biologic, or who are switched from stable Remicade?
  • To assess the safety of Inflectra? in RA, AS, and PsA patients who are either initiated with Inflectra? as their first biologic, or who are switched from stable Remicade for up to 2 years
The study will be conducted according to GCP guidelines, and data sources will be validated. The source data will consist of medical records, physician questionnaires, and patient questionnaires. Data for the study will be entered into an electronic data capture system. Questionnaires will be completed on electronic tablets. The study is a one year enrollment period with a two years follow-up period. The study plans to enroll patients throughout Canada and Europe.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
The target study population will include biologic naive rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis patients receiving Inflectra? or those switched to Inflectra? from stable treatment with Remicade?.
  • Rheumatoid Arthritis
  • Ankylosing Spondylitis
  • Psoriatic Arthritis
Drug: Infliximab (Inflectra?)
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
351
December 31, 2018
December 31, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients aged ?18 years old at the time of enrollment
  2. Patients who are prescribed Inflectra or Remicade for the treatment of rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis prescribed according to the corresponding summary of product characteristics (SmPC and Product Monograph) as determined by the investigator

Exclusion Criteria:

  1. Any reported contraindications for Inflectra according to the SmPC or Product Monograph
  2. Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its excipients or other murine proteins, at the time of enrollment
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Canada,   Czechia,   Germany,   Greece,   Spain,   United Kingdom
Czech Republic,   France,   Italy
 
NCT02605642
ZOBINF1505
C1231002 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Hospira, now a wholly owned subsidiary of Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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