PERSIST: Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02605642
• Collaborator: Hospira, now a wholly owned subsidiary of Pfizer (Industry)
• Enrollment: 351
• Locations: 38
• Actual Duration (Months): 39.7
• Patients Per Site: 9.2
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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	Phase
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 year follow-up period. The study plans to enroll patients throughout Canada and Europe.

Study Design

• 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 NAIVE TO BIOLOGICS OR SWITCHED FROM STABLE REMICADE(R) (INFLIXIMAB)
• Actual Study Start Date: Sep 10, 2015
• Actual Primary Completion Date: Dec 31, 2018
• Actual Study Completion Date: Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
CT-P13 biosimilar infliximab	Drug: CT-P13; biosimilar infliximab; Other Names: Inflectra Remsima

Outcome Measures

Primary Outcome Measures

1. Treatment Persistence With CT-P13 in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA) [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.

2. Disease Duration in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), as Recorded on the Day of Inclusion in Study [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).

3. Initial Dose of CT-P13 Infusion Administered to Participants [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.

4. Number of Participants by Initial Frequency of CT-P13 Infusion Received [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.

5. Total Dose of CT-P13 Infusion Received During Observation Period [During the observation period of 2 years]

   Total dose of infusion received by the participants were evaluated.

6. Number of Participants With Change in CT-P13 Infusion Dose [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.

7. 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) [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.

8. Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) [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.

Secondary Outcome Measures

1. Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Rheumatoid Arthritis (RA) at Months 6, 12, 18 and 24 [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.

2. Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Psoriatic Arthritis (PsA) at Months 6, 12, 18 and 24 [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.

3. Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24 [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).

4. Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis (AS) at Months 6,12,18 and 24 [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).

5. Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24 [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.

6. Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Months 6, 12, 18 and 24 [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.

7. 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 [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.

8. Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Index Score at Months 6, 12, 18 and 24 [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.

9. 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 [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.

10. 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 [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.

11. Change From Baseline in Physician Global Assessment (PGA) of Rheumatoid Diseases Activity at Months 6, 12, 18 and 24 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MHAT Trimontium OOD	Plovdiv		Bulgaria	4000
2	MHAT Kaspela EOOD	Plovdiv		Bulgaria	4001
3	Diagnostic Consultative Center 17 Sofia EOOD	Sofia		Bulgaria	1233
4	Lucere Skin Dermatology & Laser Clinic	Edmonton	Alberta	Canada	T6X 0N9
5	Nexus Clinical Research	St. John's	Newfoundland and Labrador	Canada	A1A 5E8
6	Dr. Juris Lazovskis Inc.	Sydney	Nova Scotia	Canada	B1S 3N1
7	The Waterside Clinic	Barrie	Ontario	Canada	L4M 6L2
8	William Osler Health System	Brampton	Ontario	Canada	L6T 3J1
9	Adachi Medicine Professional Corporation	Hamilton	Ontario	Canada	L8N 1Y2
10	K-W Musculoskeletal Research Inc	Kitchener	Ontario	Canada	N2M 5N6
11	Y. Liu Medicine Professional	Milton	Ontario	Canada	L9T 3Z9
12	Credit Valley Imaging Associates	Mississauga	Ontario	Canada	L5M 2V8
13	Oakville Rheumatology & Osteoporosis	Oakville	Ontario	Canada	L6M 4J2
14	Ottawa Hospital Research Institute	Ottawa	Ontario	Canada	K1Y 4G2
15	Arthur Karasik Medicine Professional Corporation	Toronto	Ontario	Canada	M9C 5N2
16	Dr. Sabeen Anwar Medicine Professional Corporation	Windsor	Ontario	Canada	N8X 1T3
17	Centre Hospitalier de l'Universite de Montreal - Notre-Dame Hospital	Montreal	Quebec	Canada	H2L 1S6
18	Centre Rhumatologie de l'Est	Rimouski	Quebec	Canada	G5L 8W1
19	Centre de Recherche Musculo-Squelettique	Trois-Rivières	Quebec	Canada	G8Z 1Y2
20	Groupe de Recherche en Rhumatologie et Maladies Osseuses (GRMO)	Quebec		Canada	G1V 3M7
21	Revmatolog Mudr. Sirova Klara s.r.o.	Ostrava		Czechia	701 00
22	Revmatologický Ústav (RÚ)	Praha 2		Czechia	12850
23	Rheumapraxis Steglitz	Berlin		Germany	12163
24	Immanuel Diakonie GmbH	Bernau		Germany	16321
25	Rheumatologisches MVZ Dresden GmbH	Dresden		Germany	01109
26	Asklepios Gesundheitszentrum Elmshorn	Elmshorn		Germany	21073
27	Rheumatologische Praxis Dr. med. Kühne	Haldensleben		Germany	39340
28	Dr. med. Jörg Kaufmann	Ludwigsfelde		Germany	14974
29	Praxis Dr. Herbert Kellner	Muenchen		Germany	80639
30	MVZ für Rheumatologie Dr. Martin Welcker GmbH	Planegg		Germany	82152
31	Berufsausübungsgemeinschaft Martin Bohl-Bühler & Dr. med. Sabine Reckert	Potsdam		Germany	14469
32	Dr. med. Jochen Walter - FA für Innere Medizin Rheumatologe	Rendsburg		Germany	24768
33	University General Hospital of Heraklion	Heraklion	Crete	Greece	71110
34	Complexo Hospitalario Universitario A Coruña	A Coruña A Coruña		Spain	15006
35	Hospital Universitario Vall d'Hebron	Barcelona		Spain	08035
36	Hospital Universitario de Canarias	San Cristóbal de La Laguna		Spain	38320
37	Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital	Portsmouth		United Kingdom	PO6 3LY
38	Salisbury NHS Foundation Trust - Salisbury District Hospital	Sailsbury		United Kingdom	SP2 8BJ

Sponsors and Collaborators

• Pfizer
• Hospira, now a wholly owned subsidiary of Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

• Study Protocol - May 17, 2017
• Statistical Analysis Plan - Jan 29, 2019

More Information

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02605642
• Other Study ID Numbers: ZOBINF1505; C1231002
• First Posted: Nov 16, 2015
• Last Update Posted: Jan 13, 2020
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Spondylitis; Arthritis; Arthritis, Psoriatic; Spondylitis, Ankylosing; Infliximab

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Participants Who Switched From Remicade to CT-P13
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	227	107
Safety Set	221	107
COMPLETED	131	86
NOT COMPLETED	96	21

Baseline Characteristics

Arm/Group Title	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Participants Who Switched From Remicade to CT-P13	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	221	107	328
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.3 (13.54)	52.5 (12.61)	53.1 (13.23)
Sex: Female, Male (Count of Participants)
Female	118 53.4%	48 44.9%	166 50.6%
Male	103 46.6%	59 55.1%	162 49.4%
Race/Ethnicity, Customized (Count of Participants)
White	212 95.9%	106 99.1%	318 97%
Black or African American	2 0.9%	0 0%	2 0.6%
Asian	6 2.7%	0 0%	6 1.8%
Other	1 0.5%	1 0.9%	2 0.6%
Height (centimeter) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeter]	168.44 (9.467)	173.19 (10.592)	169.98 (10.080)
Body Weight (kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms]	80.80 (16.613)	83.21 (19.442)	81.59 (17.592)
Body Mass Index (kilogram per meter square) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogram per meter square]	28.51 (5.521)	27.74 (5.968)	28.26 (5.672)
Participants with Medical History (Count of Participants)
Count of Participants [Participants]	221 100%	107 100%	328 100%
Surgery Status (Count of Participants)
Yes	20 9%	12 11.2%	32 9.8%
No	201 91%	95 88.8%	296 90.2%

Outcome Measures

1. Primary Outcome

Title	Treatment Persistence With CT-P13 in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA)
Description	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.
Time Frame	During the observation period of 2 years

Outcome Measure Data

Analysis Population Description

The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period.

Arm/Group Title	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Participants Who Switched From Remicade to CT-P13
Arm/Group Description	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.	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.
Measure Participants	221	107
Mean (Standard Deviation) [days]	404.10 (291.33)	542.30 (268.55)

2. Primary Outcome

Title	Disease Duration in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), as Recorded on the Day of Inclusion in Study
Description	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).
Time Frame	At Day 1 of 2 year observation period

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Participants Who Switched From Remicade to CT-P13
Arm/Group Description	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.	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.
Measure Participants	221	107
Disease Type: RA	52.928	189.142
Disease Type: AS	35.039	159.376
Disease Type: PsA	33.084	133.979

3. Primary Outcome

Title	Initial Dose of CT-P13 Infusion Administered to Participants
Description	Initial dose of CT-P13 infusion (dose at the time of CT-P13 treatment initiation) was reported in this outcome measure.
Time Frame	At Day 1 of 2 year observation period

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Participants Who Switched From Remicade to CT-P13
Arm/Group Description	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.	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.
Measure Participants	207	102
Median (Full Range) [milligram per kilogram]	3.00	4.00

4. Primary Outcome

Title	Number of Participants by Initial Frequency of CT-P13 Infusion Received
Description	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.
Time Frame	Baseline (Day 1) of 2 year observation period

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Participants Who Switched From Remicade to CT-P13
Arm/Group Description	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.	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.
Measure Participants	207	102
Once every 4 weeks	3 1.4%	1 0.9%
Once every 6 weeks	79 35.7%	42 39.3%
Once every 8 weeks	73 33%	44 41.1%
Other	52 23.5%	15 14%

5. Primary Outcome

Title	Total Dose of CT-P13 Infusion Received During Observation Period
Description	Total dose of infusion received by the participants were evaluated.
Time Frame	During the observation period of 2 years

Outcome Measure Data

Analysis Population Description

The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period.

Arm/Group Title	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Participants Who Switched From Remicade to CT-P13
Arm/Group Description	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.	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.
Measure Participants	221	107
Median (Full Range) [milligram per kilogram]	35.00	46.50

6. Primary Outcome

Title	Number of Participants With Change in CT-P13 Infusion Dose
Description	Participants who had change in the dose of infusion (either dose reduction or increase in dose) during the observation period were reported.
Time Frame	During the observation period of 2 years

Outcome Measure Data

Analysis Population Description

The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period.

Arm/Group Title	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Participants Who Switched From Remicade to CT-P13
Arm/Group Description	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.	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.
Measure Participants	221	107
Count of Participants [Participants]	40 18.1%	8 7.5%

7. Primary Outcome

Title	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)
Description	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.
Time Frame	During the observation period of 2 years

Outcome Measure Data

Analysis Population Description

The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period.

Arm/Group Title	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Participants Who Switched From Remicade to CT-P13
Arm/Group Description	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.	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.
Measure Participants	221	107
Corticosteroids	28 12.7%	2 1.9%
NSAID's	27 12.2%	5 4.7%
Immunosuppressants	48 21.7%	12 11.2%
Other	26 11.8%	2 1.9%
Missing	7 3.2%	5 4.7%

8. Primary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
Description	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.
Time Frame	During the observation period of 2 years

Outcome Measure Data

Analysis Population Description

The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period.

Arm/Group Title	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Participants Who Switched From Remicade to CT-P13
Arm/Group Description	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.	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.
Measure Participants	221	107
TEAEs	97 43.9%	29 27.1%
SAEs	19 8.6%	10 9.3%
TEAEs of Special Interest	24 10.9%	8 7.5%

9. Secondary Outcome

Title	Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Rheumatoid Arthritis (RA) at Months 6, 12, 18 and 24
Description	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.
Time Frame	Baseline, Months 6, 12, 18 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Participants Who Switched From Remicade to CT-P13
Arm/Group Description	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.	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.
Measure Participants	92	41
Baseline	4.033 (1.5186)	2.641 (1.1401)
Change at Month 6	-1.269 (1.5981)	0.210 (1.1452)
Change at Month 12	-0.642 (1.1220)	-0.432 (1.6097)
Change at Month 18	-0.795	0.534 (0.9656)

10. Secondary Outcome

Title	Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Psoriatic Arthritis (PsA) at Months 6, 12, 18 and 24
Description	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.
Time Frame	Baseline, Months 6, 12, 18 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Participants Who Switched From Remicade to CT-P13
Arm/Group Description	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.	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.
Measure Participants	46	28
Baseline	3.755 (1.7767)	2.351 (1.0677)
Change at Month 6	-0.913 (1.8785)	0.152 (0.2737)
Change at Month 12	-0.006 (1.7984)	0.259 (0.3916)
Change at Month 18	-0.747 (1.2115)	0.840 (0.9880)
Change at Month 24	-0.543	0.313 (0.2436)

11. Secondary Outcome

Title	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24
Description	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).
Time Frame	Baseline, Weeks 6, 12, 18 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Participants Who Switched From Remicade to CT-P13
Arm/Group Description	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.	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.
Measure Participants	77	38
Baseline	4.63 (2.263)	3.06 (2.313)
Change at Month 6	-1.00 (1.911)	0.01 (1.470)
Change at Month 12	-0.87 (1.816)	0.06 (2.304)
Change at Month 18	-0.55 (2.153)	-0.24 (2.015)
Change at Month 24	-1.14 (2.167)	-1.32 (2.875)

12. Secondary Outcome

Title	Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis (AS) at Months 6,12,18 and 24
Description	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).
Time Frame	Baseline, Weeks 6, 12, 18 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Participants Who Switched From Remicade to CT-P13
Arm/Group Description	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.	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.
Measure Participants	77	38
Baseline	3.153 (1.1082)	2.151 (1.0456)
Change at Month 6	-0.875 (1.3108)	-0.023 (1.1017)
Change at Month 12	-0.379 (0.9905)	-0.452 (0.8156)
Change at Month 18	-0.603 (2.7745)	-0.002 (0.3630)
Change at Month 24	-1.154 (1.2293)	-0.356 (1.7080)

13. Secondary Outcome

Title	Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24
Description	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.
Time Frame	Baseline, Weeks 6, 12, 18 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Participants Who Switched From Remicade to CT-P13
Arm/Group Description	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.	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.
Measure Participants	77	38
Baseline	4.17 (2.804)	2.89 (2.492)
Change at Month 6	-0.72 (2.107)	0.20 (1.146)
Change at Month 12	-1.01 (2.085)	0.18 (2.228)
Change at Month 18	-0.43 (2.194)	0.23 (2.257)
Change at Month 24	-1.18 (2.379)	-0.42 (3.012)

14. Secondary Outcome

Title	Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Months 6, 12, 18 and 24
Description	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.
Time Frame	Baseline, Months 6, 12, 18 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Participants Who Switched From Remicade to CT-P13
Arm/Group Description	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.	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.
Measure Participants	215	107
Baseline	0.956 (0.7493)	0.646 (0.6684)
Change at Month 6	-0.216 (0.5906)	0.026 (0.3648)
Change at Month 12	-0.207 (0.5739)	-0.043 (0.5144)
Change at Month 18	-0.150 (0.4650)	-0.021 (0.3878)
Change at Month 24	-0.398 (0.6918)	-0.153 (0.7336)

15. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline, Months 6, 12, 18 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Participants Who Switched From Remicade to CT-P13
Arm/Group Description	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.	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.
Measure Participants	215	107
Baseline	62.7 (23.55)	70.0 (22.71)
Change at Month 6	6.0 (25.55)	0.2 (20.66)
Change at Month 12	4.2 (21.93)	1.0 (26.06)
Change at Month 18	-0.8 (28.71)	-0.0 (25.98)
Change at Month 24	4.3 (16.28)	12.4 (30.99)

16. Secondary Outcome

Title	Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Index Score at Months 6, 12, 18 and 24
Description	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.
Time Frame	Baseline, Months 6, 12, 18 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Participants Who Switched From Remicade to CT-P13
Arm/Group Description	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.	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.
Measure Participants	215	107
Baseline	0.627 (0.2260)	0.757 (0.1906)
Change at Month 6	0.097 (0.2309)	0.004 (0.1859)
Change at Month 12	0.106 (0.2093)	-0.002 (0.1900)
Change at Month 18	0.102 (0.1522)	-0.041 (0.1416)
Change at Month 24	0.090 (0.1479)	-0.004 (0.1735)

17. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline, Months 6, 12, 18 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Participants Who Switched From Remicade to CT-P13
Arm/Group Description	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.	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.
Measure Participants	215	107
Baseline	37.018 (10.1214)	41.865 (10.2835)
Change at Month 6	2.679 (9.5359)	0.638 (7.5793)
Change at Month 12	3.988 (8.6626)	0.683 (8.8907)
Change at Month 18	2.325 (8.1633)	0.295 (11.0411)
Change at Month 24	4.238 (9.2347)	1.712 (7.9035)

18. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline, Months 6, 12, 18 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Participants Who Switched From Remicade to CT-P13
Arm/Group Description	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.	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.
Measure Participants	215	107
Baseline	47.154 (10.9659)	52.152 (9.8788)
Change at Month 6	2.603 (8.9694)	-0.412 (8.7364)
Change at Month 12	1.435 (8.1599)	0.119 (8.3434)
Change at Month 18	1.457 (8.0383)	-1.145 (9.9283)
Change at Month 24	-0.593 (9.7558)	5.111 (5.0804)

19. Secondary Outcome

Title	Change From Baseline in Physician Global Assessment (PGA) of Rheumatoid Diseases Activity at Months 6, 12, 18 and 24
Description	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.
Time Frame	Baseline, Months 6, 12, 18 and 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Participants Who Switched From Remicade to CT-P13
Arm/Group Description	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.	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.
Measure Participants	215	107
Baseline	34.9 (27.80)	18.4 (17.27)
Change at Month 6	-13.4 (26.94)	0.6 (18.07)
Change at Month 12	-19.2 (23.17)	-1.5 (19.02)
Change at Month 18	-12.5 (20.58)	2.1 (11.75)
Change at Month 24	-25.6 (23.49)	-3.4 (12.27)

Adverse Events

Time Frame	During the observation period of 2 years
Adverse Event Reporting Description	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.
Arm/Group Title	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive		Participants Who Switched From Remicade to CT-P13
Arm/Group Description	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.		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.
All Cause Mortality
	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive		Participants Who Switched From Remicade to CT-P13
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/221 (0%)		0/107 (0%)
Serious Adverse Events
	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive		Participants Who Switched From Remicade to CT-P13
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/221 (8.6%)		10/107 (9.3%)
Blood and lymphatic system disorders
Anaemia	0/221 (0%)		1/107 (0.9%)
Cardiac disorders
Coronary artery stenosis	0/221 (0%)		1/107 (0.9%)
Myocardial infarction	1/221 (0.5%)		0/107 (0%)
Eye disorders
Uveitis	1/221 (0.5%)		0/107 (0%)
Gastrointestinal disorders
Pancreatitis	1/221 (0.5%)		0/107 (0%)
Hepatobiliary disorders
Autoimmune hepatitis	1/221 (0.5%)		0/107 (0%)
Gallbladder polyp	1/221 (0.5%)		0/107 (0%)
Infections and infestations
Appendicitis	1/221 (0.5%)		0/107 (0%)
Bronchitis	2/221 (0.9%)		0/107 (0%)
Erysipelas	0/221 (0%)		1/107 (0.9%)
Herpes zoster	1/221 (0.5%)		1/107 (0.9%)
Lower respiratory tract infection	0/221 (0%)		1/107 (0.9%)
Necrotising herpetic retinopathy	1/221 (0.5%)		0/107 (0%)
Pilonidal cyst	0/221 (0%)		1/107 (0.9%)
Pneumonia	0/221 (0%)		1/107 (0.9%)
Tooth abscess	0/221 (0%)		1/107 (0.9%)
Injury, poisoning and procedural complications
Infusion related reaction	1/221 (0.5%)		0/107 (0%)
Pelvic fracture	1/221 (0.5%)		0/107 (0%)
Metabolism and nutrition disorders
Hypoglycaemia	0/221 (0%)		1/107 (0.9%)
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain	1/221 (0.5%)		0/107 (0%)
Osteoarthritis	2/221 (0.9%)		0/107 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma	1/221 (0.5%)		0/107 (0%)
Lip squamous cell carcinoma	1/221 (0.5%)		0/107 (0%)
Transitional cell carcinoma	1/221 (0.5%)		0/107 (0%)
Nervous system disorders
Paraesthesia	1/221 (0.5%)		0/107 (0%)
Syncope	1/221 (0.5%)		0/107 (0%)
Product Issues
Device loosening	0/221 (0%)		1/107 (0.9%)
Psychiatric disorders
Depression	1/221 (0.5%)		0/107 (0%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	0/221 (0%)		1/107 (0.9%)
Vascular disorders
Hypertensive crisis	0/221 (0%)		1/107 (0.9%)
Thrombophlebitis	0/221 (0%)		1/107 (0.9%)
Other (Not Including Serious) Adverse Events
	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive		Participants Who Switched From Remicade to CT-P13
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	88/221 (39.8%)		24/107 (22.4%)
Cardiac disorders
Cardiomyopathy	1/221 (0.5%)		0/107 (0%)
Eye disorders
Uveitis	2/221 (0.9%)		0/107 (0%)
Gastrointestinal disorders
Abdominal distension	1/221 (0.5%)		0/107 (0%)
Abdominal pain	3/221 (1.4%)		0/107 (0%)
Aphthous ulcer	1/221 (0.5%)		0/107 (0%)
Dyspepsia	1/221 (0.5%)		0/107 (0%)
General disorders
Asthenia	1/221 (0.5%)		0/107 (0%)
Cyst	0/221 (0%)		1/107 (0.9%)
Drug ineffective	25/221 (11.3%)		6/107 (5.6%)
Impaired healing	0/221 (0%)		1/107 (0.9%)
Malaise	1/221 (0.5%)		1/107 (0.9%)
Nodule	1/221 (0.5%)		0/107 (0%)
Peripheral swelling	1/221 (0.5%)		0/107 (0%)
Pyrexia	1/221 (0.5%)		0/107 (0%)
Hepatobiliary disorders
Cholelithiasis	0/221 (0%)		1/107 (0.9%)
Gallbladder polyp	1/221 (0.5%)		0/107 (0%)
Hypertransaminasaemia	1/221 (0.5%)		0/107 (0%)
Liver disorder	0/221 (0%)		1/107 (0.9%)
Infections and infestations
Bronchitis	3/221 (1.4%)		0/107 (0%)
Cystitis	0/221 (0%)		1/107 (0.9%)
Eye infection	0/221 (0%)		1/107 (0.9%)
Febrile infection	1/221 (0.5%)		0/107 (0%)
Herpes virus infection	0/221 (0%)		1/107 (0.9%)
Herpes zoster	1/221 (0.5%)		1/107 (0.9%)
Influenza	1/221 (0.5%)		0/107 (0%)
Lower respiratory tract infection	2/221 (0.9%)		0/107 (0%)
Nasal herpes	1/221 (0.5%)		1/107 (0.9%)
Nasopharyngitis	6/221 (2.7%)		1/107 (0.9%)
Oral herpes	0/221 (0%)		2/107 (1.9%)
Periodontitis	1/221 (0.5%)		0/107 (0%)
Pharyngotonsillitis	0/221 (0%)		1/107 (0.9%)
Pneumonia	3/221 (1.4%)		0/107 (0%)
Respiratory tract infection	1/221 (0.5%)		0/107 (0%)
Sinusitis	1/221 (0.5%)		1/107 (0.9%)
Tonsillitis	0/221 (0%)		1/107 (0.9%)
Tooth abscess	1/221 (0.5%)		0/107 (0%)
Tooth infection	0/221 (0%)		1/107 (0.9%)
Upper respiratory tract infection	6/221 (2.7%)		4/107 (3.7%)
Urinary tract infection	0/221 (0%)		1/107 (0.9%)
Viral infection	2/221 (0.9%)		0/107 (0%)
Injury, poisoning and procedural complications
Epicondylitis	1/221 (0.5%)		0/107 (0%)
Exposure during pregnancy	1/221 (0.5%)		0/107 (0%)
Foot fracture	1/221 (0.5%)		0/107 (0%)
Infusion related reaction	14/221 (6.3%)		2/107 (1.9%)
Investigations
Blood pressure increased	1/221 (0.5%)		0/107 (0%)
Drug specific antibody	1/221 (0.5%)		0/107 (0%)
Haemoglobin decreased	0/221 (0%)		1/107 (0.9%)
Hepatic enzyme increased	1/221 (0.5%)		0/107 (0%)
Liver function test increased	1/221 (0.5%)		0/107 (0%)
Mycobacterium tuberculosis complex test positive	1/221 (0.5%)		0/107 (0%)
Metabolism and nutrition disorders
Vitamin D deficiency	1/221 (0.5%)		0/107 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/221 (0.5%)		0/107 (0%)
Arthritis	1/221 (0.5%)		0/107 (0%)
Back pain	1/221 (0.5%)		1/107 (0.9%)
Bursitis	1/221 (0.5%)		0/107 (0%)
Chondropathy	0/221 (0%)		1/107 (0.9%)
Intervertebral disc protrusion	1/221 (0.5%)		0/107 (0%)
Joint swelling	1/221 (0.5%)		0/107 (0%)
Muscular weakness	1/221 (0.5%)		0/107 (0%)
Osteoarthritis	1/221 (0.5%)		0/107 (0%)
Pain in extremity	2/221 (0.9%)		0/107 (0%)
Rheumatic disorder	1/221 (0.5%)		0/107 (0%)
Rheumatoid arthritis	0/221 (0%)		1/107 (0.9%)
Synovitis	0/221 (0%)		1/107 (0.9%)
Tendonitis	1/221 (0.5%)		0/107 (0%)
Vertebral foraminal stenosis	0/221 (0%)		1/107 (0.9%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	1/221 (0.5%)		0/107 (0%)
Nervous system disorders
Headache	6/221 (2.7%)		0/107 (0%)
Hypoaesthesia	1/221 (0.5%)		0/107 (0%)
Intercostal neuralgia	0/221 (0%)		1/107 (0.9%)
Paraesthesia	1/221 (0.5%)		0/107 (0%)
Somnolence	1/221 (0.5%)		0/107 (0%)
Syncope	1/221 (0.5%)		0/107 (0%)
Psychiatric disorders
Insomnia	1/221 (0.5%)		0/107 (0%)
Renal and urinary disorders
Renal cyst	1/221 (0.5%)		0/107 (0%)
Renal failure	1/221 (0.5%)		1/107 (0.9%)
Reproductive system and breast disorders
Erectile dysfunction	0/221 (0%)		1/107 (0.9%)
Skin and subcutaneous tissue disorders
Alopecia	0/221 (0%)		1/107 (0.9%)
Palmoplantar pustulosis	1/221 (0.5%)		0/107 (0%)
Psoriasis	1/221 (0.5%)		0/107 (0%)
Rash	1/221 (0.5%)		1/107 (0.9%)
Skin induration	1/221 (0.5%)		0/107 (0%)
Surgical and medical procedures
Carpal tunnel decompression	1/221 (0.5%)		0/107 (0%)
Varicose vein operation	1/221 (0.5%)		0/107 (0%)
Vascular disorders
Hypertension	1/221 (0.5%)		0/107 (0%)
Hypotension	1/221 (0.5%)		0/107 (0%)
Peripheral coldness	0/221 (0%)		1/107 (0.9%)

Limitations/Caveats

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.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.