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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
Results First Posted : January 13, 2020
Last Update Posted : January 13, 2020
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
Results First Submitted Date December 20, 2019
Results First Posted Date January 13, 2020
Last Update Posted Date January 13, 2020
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: December 20, 2019)
  • 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 ]
    Persistence (in days) was defined as a continuous variable measured in time from index date until date of drug discontinuation. Drug discontinuation was defined as either switching to another non infliximab BDMARD or elapsing of a drug free interval of 16 weeks from CT-P13. For participants undergoing a switch to CT-P13 from Remicade, the index date was considered the date from which Remicade was originally commenced and for participants who initiated treatment with CT-P13 as their first biologic, the index date was considered the date from which CT-P13 was initiated.
  • 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 ]
    Disease duration was defined as the number of months from initial diagnosis of rheumatoid disease (RA, AS or PsA) to the date of informed consent, which was recorded at the time of inclusion in the study (Day 1).
  • Initial Dose of CT-P13 Infusion Administered to Participants [ Time Frame: At Day 1 of 2 year observation period ]
    Initial dose of CT-P13 infusion (dose at the time of CT-P13 treatment initiation) was reported in this outcome measure.
  • Number of Participants by Initial Frequency of CT-P13 Infusion Received [ Time Frame: Baseline (Day 1) of 2 year observation period ]
    Initial frequency of CT-P13 infusion was categorized as: once every 4, 6, 8 weeks and other. 'Other' included all other frequencies other than specified. Number of participants by baseline infusion frequency (in weeks) were reported.
  • Total Dose of CT-P13 Infusion Received During Observation Period [ Time Frame: During the observation period of 2 years ]
    Total dose of infusion received by the participants were evaluated.
  • Number of Participants With Change in CT-P13 Infusion Dose [ Time Frame: During the observation period of 2 years ]
    Participants who had change in the dose of infusion (either dose reduction or increase in dose) during the observation period were reported.
  • 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 ]
    Concomitant medications included corticosteroids, non-steroidal anti- inflammatory drugs (NSAID'S) and immunosuppressant. Participants were counted in more than one categories. 'Others' included DMARDS and other medications apart from the categories specified.
  • 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 ]
    An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent were events between first dose of infusion up to 2 years, that were absent before treatment or that worsened relative to pretreatment state. Serious infections including sepsis (excluding opportunistic infections and tuberculosis) were the pre-defined TEAE of special Interest for this study. AEs included both serious and non-serious adverse events.
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: December 20, 2019)
  • 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 ]
    DAS28 calculated from the number of tender joint count (TJC) and swollen joint count (SJC) using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeters per hour; ranged from 0 to 150), and a participant's general health assessment (GH) on a 100 millimeter (mm) visual analog scale (VAS) (ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicated worsening of health condition). Total DAS28 score ranged from 0 (none) to 9.4 (extreme disease activity), higher scores indicated more disease activity. DAS28 less than or equal to (<=) 3.2 implied low, greater than (>) 3.2 to <=5.1 implied moderate, and >5.1 implied high disease activity. DAS28=0.56*sqrt(28TJC)+0.28*sqrt(28SJC)+0.70*ln(ESR)+0.014*GH; where ln = natural logarithm and sqrt = square root of.
  • 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 ]
    DAS28 calculated from the number of TJC and SJC using 28 joints count, ESR (millimeters per hour; ranged from 0 to 150), and participant's GH on a 100 mm VAS (ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicated worsening of health condition). Total DAS28 score ranged from 0 (none) to 9.4 (extreme disease activity), higher scores indicated more disease activity. DAS28 <= 3.2 implied low, > 3.2 to <=5.1 implied moderate, and >5.1 implied high disease activity. DAS28=0.56*sqrt(28TJC)+0.28*sqrt(28SJC)+0.70*ln(ESR)+0.014*GH; where ln = natural logarithm and sqrt = square root of.
  • 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 ]
    BASDAI is a self-reported measure of disease activity in participants with AS. Participants answered 6 questions measuring symptoms of AS (fatigue, spinal pain, joint pain or swelling, areas of localized tenderness, morning stiffness duration and severity). The BASDAI total score was calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score was then divided by 5. BASDAI=Q1+Q2+Q3+Q4+[Q5+Q6/2]/5. The total BASDAI score ranges from 1=none to 10=severe, where lower score indicated less disease activity. The level of AS disease activity was interpreted as low (BASDAI < 4) or high (BASDAI > 4).
  • 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 ]
    ASDAS is used to assess disease activity in participants with AS. It is a score combining the assessment of overall pain (Q1), duration of morning stiffness (Q2), peripheral pain/swelling (Q3), PtGA (assessed on a sale of 0 to 10, where 0 = not active and 10=very active), and C-reactive protein (CRP) in milligrams per liter (mg/L). ASDAS total score was derived using the following formula: ASDAS=0.12*Q1+0.06*Q2+0.11*GH+0.07*Q3+0.58*ln (CRP+1). The level of AS disease activity was interpreted as inactive disease (ASDAS< 1.3), moderate disease activity (1.3 <= ASDAS < 2.1), high disease activity (2.1<= ASDAS <=3.5) and very high disease activity (ASDAS > 3.5).
  • 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 ]
    BASFI is a validated self assessment tool to determine the degree of functional limitation in participants with AS. It is comprised of 10 questions which were answered by participants using a VAS ranging from 0 (being easy) to 10 (impossible). BASFI total score was calculated as the average score of the 10 questions, and ranges from 0 (no functional impairment) to 10 (maximal impairment), higher scores indicated more impairment.
  • 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 ]
    HAQ-DI assesses the degree of difficulty a participant had experienced in 8 domains of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale from 0 to 3 with 0 ="no difficulty", 1 ="some difficulty", 2 = "much difficulty", and 3 ="unable to do". Overall score was computed as the sum of scores divided by the number of domains answered. Total possible score range was 0-3 with 0 = "no difficulty to 3 ="unable to do". Higher score indicate more difficulty in performing daily living activities.
  • 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 ]
    EQ-5D-3L is a standardized, participant-administered measure of health outcomes. It consists of two parts: EQ-5D descriptive system (Part I) and the EQ-VAS (Part II). EQ-5D-3L Part II uses a vertical graduated VAS to measure health status on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicating a better health state.
  • 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 ]
    EQ-5D-3L is a standardized, participant-administered measure of self-reported health outcomes. It consists of two parts: EQ-5D descriptive system (Part I) and the EQ-VAS (Part II). For Part I, i.e. EQ-5D-3L index score, participants rated their current health state on 5 single-item dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with each dimension having three levels of function:. 1=no problems, 2=some problems and 3=extreme problems. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score was transformed and results in a total score range of -0.074 to 1.00; higher scores indicating a better health state.
  • 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 ]
    The SF-12v2 is a self-administered, validated, multipurpose SF questionnaire to measure generic health status. It consists of 12 items, which are categorized into eight domains (subscales) of functioning and well-being: physical function, role limitations due to physical problems, bodily pain, general health perceptions, energy and vitality, social functioning, role limitations due to emotional problems, and mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. These eight domains are further summarized into PCS and mental component summary (MCS). The score range for each of these 2 summary scores was from 0 (poor health) to 100 (better health). Higher scores indicated a better health-related quality of life.
  • 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 ]
    The SF-12v2 is a self-administered, validated, multipurpose SF questionnaire to measure generic health status. It consists of 12 items, which are categorized into eight domains (subscales) of functioning and well-being: physical function, role limitations due to physical problems, bodily pain, general health perceptions, energy and vitality, social functioning, role limitations due to emotional problems, and mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. These eight domains are further summarized into PCS and mental component summary (MCS). The score range for each of these 2 summary scores was from 0 (poor health) to 100 (better health). Higher scores indicated a better health-related quality of life.
  • 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 ]
    PGA of disease activity was measured on a 0 to 100 mm VAS, where 0 mm = no disease activity and 100 mm = extremely active. Higher scores indicated worsening of condition.
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 year 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 December 2019