| 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) |
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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
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| 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
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| Drug: Infliximab (Inflectra?) |
| Not Provided |
| Not Provided |
| |
| Active, not recruiting |
| 351 |
| December 31, 2018 |
| December 31, 2018 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- Patients aged ?18 years old at the time of enrollment
- 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:
- Any reported contraindications for Inflectra according to the SmPC or Product Monograph
- Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its excipients or other murine proteins, at the time of enrollment
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| Sexes Eligible for Study: |
All |
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| 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 |
