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Trial record 1 of 1 for:    NCT02605642
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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 (PERSIST)

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ClinicalTrials.gov Identifier: NCT02605642
Recruitment Status : Completed
First Posted : November 16, 2015
Last Update Posted : March 8, 2019
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date September 2, 2015
First Posted Date November 16, 2015
Last Update Posted Date March 8, 2019
Actual Study Start Date September 10, 2015
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 20, 2018)
  • Time to discontinuation from study drug in patients with rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years, as directed by the patient's condition and local medical practice ]
    In patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade
  • Reason for study discontinuation [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years, as directed by the patient's condition and local medical practice ]
    Using predefined categories pertaining to efficacy, safety and tolerability in patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade
  • Evaluation of disease duration in patients with rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years, as directed by the patient's condition and local medical practice. ]
    In patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade
  • Evaluation of surgery status in patients with rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years, as directed by the patient's condition and local medical practice. ]
    In patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade
  • Change from baseline of drug dose frequency in patients with rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years, as directed by the patient's condition and local medical practice. ]
    In patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade
  • Evaluation of subjects with serious adverse events (SAEs) and Adverse events of special interest (AESIs) as a measure of safety of CT-P13 in patients with rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years, as directed by the patient's condition and local medical practice. ]
    In patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade
  • Evaluation of concomitant medication use in patients with rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years, as directed by the patient's condition and local medical practice. ]
    In patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade
Original Primary Outcome Measures
 (submitted: November 12, 2015)
  • Time to discontinuation from study drug in rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis patients [ Time Frame: Approximately every 2 months, with a total follow-up of 2 years ]
    In patients who are either initiated with Inflectra™ as their first biologic, or who are switched from stable Remicade™
  • Reason for study discontinuation [ Time Frame: Approximately every 2 months, with a total follow-up of 2 years ]
    Using predefined categories pertaining to efficacy, safety and tolerability. In patients who are either initiated with Inflectra™ as their first biologic, or who are switched from stable Remicade™
  • Evaluation of disease duration in rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis patient [ Time Frame: Approximately every 2 months, with a total follow-up of 2 years ]
    In patients who are either initiated with Inflectra™ as their first biologic, or who are switched from stable Remicade™
  • Evaluation of surgery status in rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis patient [ Time Frame: Approximately every 2 months, with a total follow-up of 2 years ]
    In patients who are either initiated with Inflectra™ as their first biologic, or who are switched from stable Remicade™.
  • Evaluation of drug dose in rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis patient [ Time Frame: Approximately every 2 months, with a total follow-up of 2 years ]
    In patients who are either initiated with Inflectra™ as their first biologic, or who are switched from stable Remicade™.
  • Number of subjects with serious adverse events (SAE) as a measure of safety of Inflectra™ in rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis [ Time Frame: Up to 2 years ]
    In patients who are either initiated with Inflectra™ as their first biologic, or who are switched from stable Remicade™
  • Number of subjects with Adverse events of special interest (AESI) as a measure of safety of Inflectra™ in rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis [ Time Frame: Up to 2 years ]
    In patients who are either initiated with Inflectra™ as their first biologic, or who are switched from stable Remicade™.
  • Evaluation of drug frequency in rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis patient [ Time Frame: Approximately every 2 months, with a total follow-up of 2 years ]
    In patients who are either initiated with Inflectra™ as their first biologic, or who are switched from stable Remicade™.
  • Evaluation of concomitant medication use in rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis patient [ Time Frame: Approximately every 2 months, with a total follow-up of 2 years ]
    In patients who are either initiated with Inflectra™ as their first biologic, or who are switched from stable Remicade™.
Change History Complete list of historical versions of study NCT02605642 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 20, 2018)
  • Assessment of CT-P13 effectiveness in rheumatoid arthritis patient by Disease Activity Score (DAS28) [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years. ]
  • Assessment of CT-P13 effectiveness in psoriatic arthritis patient by DAS28 score [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years. ]
  • Assessment of CT-P13 effectiveness in ankylosing spondylitis patients by Ankylosing Spondylitis Disease Activity Score (ASDAS) [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years. ]
  • Evaluation of levels of pain, discomfort and fatigue in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis patients using a Visual Analog Scale (VAS: 0-10) [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years. ]
    VAS Range for pain: No pain to very severe pain; Discomfort: Easy to impossible; Fatigue: Not active to very active
  • Clinical evaluation of disease activity by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Ankylosing Spondylitis patients [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years. ]
  • Clinical evaluation of disease activity by Bath Ankylosing Spondylitis Functional Index (BASFI) in ankylosing spondylitis patients [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years. ]
  • Assessment of patient reported outcome measure by Health Assessment Questionnaire Disability Index (HAQ-DI) in rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis patients [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years. ]
  • Assessment of patient reported outcome measure by Short Form 12-version 2 (SF-12v2) in rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis patients [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years. ]
  • Assessment of patient reported outcome measure by EuroQol 5-Dimensions 3-levels (EQ-5D-3L) rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years. ]
  • Assess the Physician Global Assessment using Visual Analog Scale (VAS: 0-10) [ Time Frame: From enrolment through the end of the follow-up period, up to 2 years. ]
    VAS range: 0 - 10 (No disease activity to Extremely active)
Original Secondary Outcome Measures
 (submitted: November 12, 2015)
  • Assessment of Infliximab effectiveness in rheumatoid arthritis patient by Disease Activity Score (DAS28) [ Time Frame: Up to 2 years ]
  • Assessment of Infliximab effectiveness in psoriatic arthritis patient by DAS28 score [ Time Frame: Up to 2 years ]
  • Assessment of Infliximab effectiveness in ankylosing spondylitis patients by Ankylosing Spondylitis Disease Activity Score (ASDAS) [ Time Frame: Up to 2 years ]
  • Evaluation of levels of pain, discomfort and fatigue in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis patients using a Visual Analog Scale (VAS: 0-10) [ Time Frame: Up to 2 years ]
    VAS Range for pain: No pain to very severe pain; Discomfort: Easy to impossible; Fatigue: Not active to very active
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Ankylosing Spondylitis patients [ Time Frame: Up to 2 years ]
  • Bath Ankylosing Spondylitis Functional Index (BASFI) in ankylosing spondylitis patients [ Time Frame: Up to 2 years ]
  • Assessment of patient reported outcome measure by Health Assessment Questionnaire Disability Index (HAQ-DI) in rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis patients [ Time Frame: Up to 2 years ]
  • Assessment of patient reported outcome measure by Short Form 12-version 2 (SF-12v2) in rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis patients [ Time Frame: Up to 2 years ]
  • Assessment of patient reported outcome measure by EuroQol 5-Dimensions 3-levels (EQ-5D-3L) rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis [ Time Frame: Up to 2 years ]
  • Assess the Physician Global Assessment using Visual Analog Scale (VAS: 0-10) [ Time Frame: Up to 2 years ]
    VAS range: 0 - 10 (No disease activity to Extremely active)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: November 12, 2015)
Assess the immunogenicity profile (therapeutic drug monitoring) [ Time Frame: Up to 2 years ]
Measurement of Anti-Drug antibodies to infliximab and infliximab trough levels using a validated ELISA kit
 
Descriptive Information
Brief 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
Official 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)
Brief 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
Detailed Description The study will be conducted in accordance with legal and regulatory requirements with scientific purpose, value and rigor following generally accepted research practices described in Guidelines for Good Pharmacoepidemiology Practices (GPP), Good Epidemiological Practice (GEP), Good Practices for Outcomes Research, International Ethical Guidelines for Epidemiological Research, European Medicines Agency (EMA) European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological Standards in Pharmacoepidemiology, and FDA Guidance for Industry. Data sources will be validated and will consist of the hospital medical records and monitoring will be organized on a regular basis. 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The target study population will include biologic naïve rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis patients starting biologic treatment with CT-P13 or those switched to CT-P13 from stable Remicade treatment
Condition
  • Rheumatoid Diseases
  • Rheumatoid Arthritis
  • Ankylosing Spondylitis
  • Psoriatic Arthritis
Intervention Drug: CT-P13
biosimilar infliximab
Other Names:
  • Inflectra
  • Remsima
Study Groups/Cohorts CT-P13
biosimilar infliximab
Intervention: Drug: CT-P13
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 12, 2017)
351
Original Estimated Enrollment
 (submitted: November 12, 2015)
1500
Actual Study Completion Date December 31, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Bulgaria,   Canada,   Czechia,   Germany,   Greece,   Spain,   United Kingdom
Removed Location Countries Czech Republic,   France,   Italy
 
Administrative Information
NCT Number NCT02605642
Other Study ID Numbers ZOBINF1505
C1231002 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Hospira, now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2019