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| ID | Type | Description | Link |
|---|---|---|---|
| C1231002 | Other Identifier | Alias Study Number |
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| Name | Class |
|---|---|
| Hospira, now a wholly owned subsidiary of Pfizer | INDUSTRY |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P13 | biosimilar infliximab |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P13 | Drug | biosimilar infliximab |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment Persistence With CT-P13 in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA) | 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. | During the observation period of 2 years |
| Disease Duration in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), as Recorded on the Day of Inclusion in Study | 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). | At Day 1 of 2 year observation period |
| Initial Dose of CT-P13 Infusion Administered to Participants | Initial dose of CT-P13 infusion (dose at the time of CT-P13 treatment initiation) was reported in this outcome measure. | At Day 1 of 2 year observation period |
| Number of Participants by Initial Frequency of CT-P13 Infusion Received | 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. | Baseline (Day 1) of 2 year observation period |
| Total Dose of CT-P13 Infusion Received During Observation Period |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Rheumatoid Arthritis (RA) at 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MHAT Trimontium OOD | Plovdiv | 4000 | Bulgaria | |||
| MHAT Kaspela EOOD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34377890 | Derived | Taylor PC, Christensen R, Moosavi S, Selema P, Guilatco R, Fowler H, Mueller M, Liau KF, Haraoui B. Real-life drug persistence in patients with rheumatic diseases treated with CT-P13: a prospective observational cohort study (PERSIST). Rheumatol Adv Pract. 2021 Apr 23;5(2):rkab026. doi: 10.1093/rap/rkab026. eCollection 2021. |
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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.
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351 participants were included in this study, however, 17 participants were excluded from all analysis (they were neither BDMARD naive nor switched from Remicade). They switched to CT-P13 from a BDMARD other than Remicade, therefore not considered for any analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive | BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 17, 2017 | Dec 20, 2019 |
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Total dose of infusion received by the participants were evaluated. |
| During the observation period of 2 years |
| Number of Participants With Change in CT-P13 Infusion Dose | Participants who had change in the dose of infusion (either dose reduction or increase in dose) during the observation period were reported. | During the observation period of 2 years |
| 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) | 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. | 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) | 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. | During the observation period of 2 years |
| Baseline, Months 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 | 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. | Baseline, Months 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 | 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). | Baseline, Weeks 6, 12, 18 and 24 |
| Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis (AS) at Months 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). | 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 | 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. | Baseline, Weeks 6, 12, 18 and 24 |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | Baseline, Months 6, 12, 18 and 24 |
| Plovdiv |
| 4001 |
| Bulgaria |
| Diagnostic Consultative Center 17 Sofia EOOD | Sofia | 1233 | Bulgaria |
| Lucere Skin Dermatology & Laser Clinic | Edmonton | Alberta | T6X 0N9 | Canada |
| Nexus Clinical Research | St. John's | Newfoundland and Labrador | A1A 5E8 | Canada |
| Dr. Juris Lazovskis Inc. | Sydney | Nova Scotia | B1S 3N1 | Canada |
| The Waterside Clinic | Barrie | Ontario | L4M 6L2 | Canada |
| William Osler Health System | Brampton | Ontario | L6T 3J1 | Canada |
| Adachi Medicine Professional Corporation | Hamilton | Ontario | L8N 1Y2 | Canada |
| K-W Musculoskeletal Research Inc | Kitchener | Ontario | N2M 5N6 | Canada |
| Y. Liu Medicine Professional | Milton | Ontario | L9T 3Z9 | Canada |
| Credit Valley Imaging Associates | Mississauga | Ontario | L5M 2V8 | Canada |
| Oakville Rheumatology & Osteoporosis | Oakville | Ontario | L6M 4J2 | Canada |
| Ottawa Hospital Research Institute | Ottawa | Ontario | K1Y 4G2 | Canada |
| Arthur Karasik Medicine Professional Corporation | Toronto | Ontario | M9C 5N2 | Canada |
| Dr. Sabeen Anwar Medicine Professional Corporation | Windsor | Ontario | N8X 1T3 | Canada |
| Centre Hospitalier de l'Universite de Montreal - Notre-Dame Hospital | Montreal | Quebec | H2L 1S6 | Canada |
| Groupe de Recherche en Rhumatologie et Maladies Osseuses (GRMO) | Québec | Quebec | G1V 3M7 | Canada |
| Centre Rhumatologie de l'Est | Rimouski | Quebec | G5L 8W1 | Canada |
| Centre de Recherche Musculo-Squelettique | Trois-Rivières | Quebec | G8Z 1Y2 | Canada |
| Revmatolog Mudr. Sirova Klara s.r.o. | Ostrava | 701 00 | Czechia |
| Revmatologický Ústav (RÚ) | Prague | 12850 | Czechia |
| Rheumapraxis Steglitz | Berlin | 12163 | Germany |
| Immanuel Diakonie GmbH | Bernau | 16321 | Germany |
| Rheumatologisches MVZ Dresden GmbH | Dresden | 01109 | Germany |
| Asklepios Gesundheitszentrum Elmshorn | Elmshorn | 21073 | Germany |
| Rheumatologische Praxis Dr. med. Kühne | Haldensleben I | 39340 | Germany |
| Dr. med. Jörg Kaufmann | Ludwigsfelde | 14974 | Germany |
| Praxis Dr. Herbert Kellner | München | 80639 | Germany |
| MVZ für Rheumatologie Dr. Martin Welcker GmbH | Planegg | 82152 | Germany |
| Berufsausübungsgemeinschaft Martin Bohl-Bühler & Dr. med. Sabine Reckert | Potsdam | 14469 | Germany |
| Dr. med. Jochen Walter - FA für Innere Medizin Rheumatologe | Rendsburg | 24768 | Germany |
| University General Hospital of Heraklion | Heraklion | Crete | 71110 | Greece |
| Complexo Hospitalario Universitario A Coruña | A Coruña A Coruña | 15006 | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario de Canarias | San Cristóbal de La Laguna | 38320 | Spain |
| Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital | Portsmouth | PO6 3LY | United Kingdom |
| Salisbury NHS Foundation Trust - Salisbury District Hospital | Sailsbury | SP2 8BJ | United Kingdom |
| Participants Who Switched From Remicade to CT-P13 |
Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years. |
| Safety Set | Included all participants who received at least 1 dose of CT- P13 during study observation period |
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| NOT COMPLETED |
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Safety analysis set included all participants who received at least 1 dose of CT-P13 during the study observation period.
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| ID | Title | Description |
|---|---|---|
| BG000 | Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive | BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years. |
| BG001 | Participants Who Switched From Remicade to CT-P13 | Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Height | Number analyzed signifies participants evaluable for this baseline measure. | Mean | Standard Deviation | centimeter |
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| Body Weight | Mean | Standard Deviation | kilograms |
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| Body Mass Index | Number analyzed signifies participants evaluable for this baseline measure. | Mean | Standard Deviation | kilogram per meter square |
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| Participants with Medical History | Number of participants with at least one clinically relevant medical history/condition (rheumatoid arthritis [RA], ankylosing spondylitis [AS], or psoriatic arthritis [PsA]) were reported. | Count of Participants | Participants |
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| Surgery Status | Surgery status was defined as 'yes', if the participant had prior surgical treatment related to the treatment of RA, PsA or AS, and as 'no' if did not have prior surgical treatment. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
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| Primary | Treatment Persistence With CT-P13 in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA) | 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. | The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period. | Posted | Mean | Standard Deviation | days | During the observation period of 2 years |
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| Primary | Disease Duration in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), as Recorded on the Day of Inclusion in Study | 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). | The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | Posted | Median | Full Range | months | At Day 1 of 2 year observation period |
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| Primary | Initial Dose of CT-P13 Infusion Administered to Participants | Initial dose of CT-P13 infusion (dose at the time of CT-P13 treatment initiation) was reported in this outcome measure. | The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period. Here "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Median | Full Range | milligram per kilogram | At Day 1 of 2 year observation period |
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| Primary | Number of Participants by Initial Frequency of CT-P13 Infusion Received | 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. | The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period. Here "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline (Day 1) of 2 year observation period |
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| Primary | Total Dose of CT-P13 Infusion Received During Observation Period | Total dose of infusion received by the participants were evaluated. | The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period. | Posted | Median | Full Range | milligram per kilogram | During the observation period of 2 years |
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| Primary | Number of Participants With Change in CT-P13 Infusion Dose | Participants who had change in the dose of infusion (either dose reduction or increase in dose) during the observation period were reported. | The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period. | Posted | Count of Participants | Participants | During the observation period of 2 years |
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| Primary | 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) | 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. | The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period. | Posted | Count of Participants | Participants | During the observation period of 2 years |
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| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) | 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. | The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period. | Posted | Count of Participants | Participants | During the observation period of 2 years |
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| Secondary | Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Rheumatoid Arthritis (RA) at 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. | Analysis performed on participants who had received at least one dose of CT-P13 and had at least one post-dose assessment for DAS28. 'Overall number of participants analyzed': participants who were evaluable for this outcome measure. 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Months 6, 12, 18 and 24 |
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| Secondary | Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Psoriatic Arthritis (PsA) at 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. | Analysis performed on participants who had received at least one dose of CT-P13 and had at least one post-dose assessment for DAS28. 'Overall number of participants analyzed': participants who were evaluable for this outcome measure. 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Months 6, 12, 18 and 24 |
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| Secondary | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Participants With Ankylosing Spondylitis (AS) at Months 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). | Analysis performed on participants who had received at least one dose of CT-P13 and had at least one post-dose assessment for BASDAI. 'Overall number of participants analyzed': participants who were evaluable for this outcome measure. 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 6, 12, 18 and 24 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis (AS) at Months 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). | Analysis performed on participants who had received at least one dose of CT-P13 and had at least one post-dose assessment for ASDAS. 'Overall number of participants analyzed': participants who were evaluable for this outcome measure. 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 6, 12, 18 and 24 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Participants With Ankylosing Spondylitis (AS) at Months 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. | Analysis performed on participants who had received at least one dose of CT-P13 and had at least one post-dose assessment for BASFI. 'Overall number of participants analyzed': participants who were evaluable for this outcome measure. 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 6, 12, 18 and 24 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at 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. | Analysis performed on participants who had received at least one dose of CT-P13 during the study observation period and had at least one post-dose assessment of HAQ-DI. Here 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Months 6, 12, 18 and 24 |
| ||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | Analysis was performed on participants who had received at least one dose of CT-P13 during the study observation period and had at least one post-dose assessment of EQ-5D-3L. Here 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Months 6, 12, 18 and 24 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Index Score at 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. | Analysis was performed on participants who had received at least one dose of CT-P13 during the study observation period and had at least one post-dose assessment of EQ-5D-3L. Here 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Months 6, 12, 18 and 24 |
| ||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | Analysis was performed on participants who had received at least one dose of CT-P13 during the study observation period and had at least one post-dose assessment of SF-12v2. Here 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Months 6, 12, 18 and 24 |
| ||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | Analysis was performed on participants who had received at least one dose of CT-P13 during the study observation period and had at least one post-dose assessment of SF-12v2. Here 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Months 6, 12, 18 and 24 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Physician Global Assessment (PGA) of Rheumatoid Diseases Activity at 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. | Analysis was performed on participants who had received at least one dose of CT-P13 during the study observation period and had at least one post-dose assessment of PGA. Here 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | Posted | Mean | Standard Deviation | millimeters | Baseline, Months 6, 12, 18 and 24 |
|
During the observation period of 2 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive | BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years. | 0 | 221 | 19 | 221 | 88 | 221 |
| EG001 | Participants Who Switched From Remicade to CT-P13 | Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years. | 0 | 107 | 10 | 107 | 24 | 107 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Gallbladder polyp | Hepatobiliary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Necrotising herpetic retinopathy | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pilonidal cyst | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA v21.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Non-systematic Assessment |
| |
| Lip squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Non-systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Device loosening | Product Issues | MedDRA v21.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA v21.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiomyopathy | Cardiac disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Cyst | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Drug ineffective | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Nodule | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Gallbladder polyp | Hepatobiliary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Nasal herpes | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA v21.1 | Non-systematic Assessment |
| |
| Exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA v21.1 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA v21.1 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v21.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Drug specific antibody | Investigations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Mycobacterium tuberculosis complex test positive | Investigations | MedDRA v21.1 | Non-systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Chondropathy | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Rheumatic disorder | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Vertebral foraminal stenosis | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Intercostal neuralgia | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Palmoplantar pustulosis | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Skin induration | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Carpal tunnel decompression | Surgical and medical procedures | MedDRA v21.1 | Non-systematic Assessment |
| |
| Varicose vein operation | Surgical and medical procedures | MedDRA v21.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v21.1 | Non-systematic Assessment |
| |
| Peripheral coldness | Vascular disorders | MedDRA v21.1 | Non-systematic Assessment |
|
Due to erroneous data transmission/ data discrepancies which occurred with use of the electronic data capture tool, data summaries only for a portion of the data for OM 9 to 19, which corresponded to visit dates in clinical database were provided.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 8007181021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 29, 2019 | Dec 20, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D013167 | Spondylitis, Ankylosing |
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D000844 | Ankylosis |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591237 | CT-P13 |
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
|
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| Units | Counts |
|---|---|
| Participants |
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| Units |
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| Counts |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years. |
|
|
| OG001 | Participants Who Switched From Remicade to CT-P13 | Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years. |
|
|
Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years. |
|
|
| Participants Who Switched From Remicade to CT-P13 |
Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years. |
|
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| Participants Who Switched From Remicade to CT-P13 |
Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years. |
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Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.
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Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years. |
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| OG001 | Participants Who Switched From Remicade to CT-P13 | Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years. |
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| OG001 | Participants Who Switched From Remicade to CT-P13 | Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years. |
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| Units | Counts |
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| Participants |
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