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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02605642
Date of registration: 02/09/2015
Prospective Registration: Yes
Primary sponsor: Pfizer
Public title: Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade PERSIST
Scientific title: PERSIST: PROSPECTIVE OBSERVATIONAL COHORT STUDY TO ASSESS PERSISTENCE OF CT-P13 (INFLIXIMAB) IN PATIENTS WITH RHEUMATOID DISEASES WHO ARE EITHER NAIVE TO BIOLOGICS OR SWITCHED FROM STABLE REMICADE(R) (INFLIXIMAB)
Date of first enrolment: September 10, 2015
Target sample size: 351
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02605642
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Bulgaria Canada Czech Republic Czechia France Germany Greece Italy
Spain United Kingdom
Contacts
Name:     Pfizer CT.gov Call Center
Address: 
Telephone:
Email:
Affiliation:  Pfizer
Key inclusion & exclusion criteria

Inclusion Criteria:

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

2. Patients who are prescribed CT-P13 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Ankylosing Spondylitis
Psoriatic Arthritis
Rheumatoid Arthritis
Rheumatoid Diseases
Intervention(s)
Drug: CT-P13
Primary Outcome(s)
Disease Duration in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), as Recorded on the Day of Inclusion in Study [Time Frame: At Day 1 of 2 year observation period]
Initial Dose of CT-P13 Infusion Administered to Participants [Time Frame: At Day 1 of 2 year observation period]
Number of Participants by Initial Frequency of CT-P13 Infusion Received [Time Frame: Baseline (Day 1) of 2 year observation period]
Number of Participants Who Had At Least One Concomitant Medication Related to the Treatment of Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA) [Time Frame: During the observation period of 2 years]
Number of Participants With Change in CT-P13 Infusion Dose [Time Frame: During the observation period of 2 years]
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) [Time Frame: During the observation period of 2 years]
Total Dose of CT-P13 Infusion Received During Observation Period [Time Frame: During the observation period of 2 years]
Treatment Persistence With CT-P13 in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA) [Time Frame: During the observation period of 2 years]
Secondary Outcome(s)
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis (AS) at Months 6,12,18 and 24 [Time Frame: Baseline, Weeks 6, 12, 18 and 24]
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24 [Time Frame: Baseline, Weeks 6, 12, 18 and 24]
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24 [Time Frame: Baseline, Weeks 6, 12, 18 and 24]
Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Psoriatic Arthritis (PsA) at Months 6, 12, 18 and 24 [Time Frame: Baseline, Months 6, 12, 18 and 24]
Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Rheumatoid Arthritis (RA) at Months 6, 12, 18 and 24 [Time Frame: Baseline, Months 6, 12, 18 and 24]
Change From Baseline in European Quality of Life- 5 Dimensions 3 Level Version (EQ-5D-3L) Visual Analog Scale (VAS) Score at Months 6, 12, 18 and 24 [Time Frame: Baseline, Months 6, 12, 18 and 24]
Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Index Score at Months 6, 12, 18 and 24 [Time Frame: Baseline, Months 6, 12, 18 and 24]
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Months 6, 12, 18 and 24 [Time Frame: Baseline, Months 6, 12, 18 and 24]
Change From Baseline in Mental Component Summary (MCS) Score of Short Form 12 Version 2 (SF-12v2) Health Survey at Months 6, 12, 18 and 24 [Time Frame: Baseline, Months 6, 12, 18 and 24]
Change From Baseline in Physical Component Summary (PCS) Score of Short Form 12 Version 2 (SF-12v2) Health Survey at Months 6, 12, 18 and 24 [Time Frame: Baseline, Months 6, 12, 18 and 24]
Change From Baseline in Physician Global Assessment (PGA) of Rheumatoid Diseases Activity at Months 6, 12, 18 and 24 [Time Frame: Baseline, Months 6, 12, 18 and 24]
Secondary ID(s)
C1231002
ZOBINF1505
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Hospira, now a wholly owned subsidiary of Pfizer
Ethics review
Results
Results available: Yes
Date Posted: 13/01/2020
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02605642
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