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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 : Active, not recruiting
First Posted : November 16, 2015
Last Update Posted : November 22, 2018
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment
Rheumatoid Diseases Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis Drug: CT-P13

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
Actual Enrollment : 351 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PERSIST: Prospective Observational Cohort Study To Assess Persistence Of CT-P13 (Infliximab) In Patients With Rheumatoid Diseases Who Are Either Naïve To Biologics Or Switched From Stable Remicade (Infliximab)
Actual Study Start Date : September 10, 2015
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018


Group/Cohort Intervention/treatment
CT-P13
biosimilar infliximab
Drug: CT-P13
biosimilar infliximab
Other Names:
  • Inflectra
  • Remsima




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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


Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. 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. ]
  4. 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

  5. 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. ]
  6. 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. ]
  7. 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. ]
  8. 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. ]
  9. 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. ]
  10. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02605642


  Show 38 Study Locations
Sponsors and Collaborators
Pfizer
Hospira, now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02605642     History of Changes
Other Study ID Numbers: ZOBINF1505
C1231002 ( Other Identifier: Alias Study Number )
First Posted: November 16, 2015    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018

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

Keywords provided by Pfizer:
CT-P13
Inflectra
Remsima
Remicade
Infliximab
Observational
Follow-up
Safety

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Spondylitis
Spondylitis, Ankylosing
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents