Trial · NCT02605642

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

NCT02605642, Completed, Pfizer; results first posted 2020-01-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade. Trials, record NCT02605642. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02605642

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade
NCT number: NCT02605642
Status: Completed
Enrollment: 351 participants, actual
Lead sponsor: Pfizer
Conditions: Rheumatoid Diseases, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
Interventions: CT-P13
First posted: 2015-11-16
Last updated: 2020-01-13
Results first posted: 2020-01-13
Limitations and 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.

Source ClinicalTrials.gov

Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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.
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	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).
Primary	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.
Primary	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.
Primary	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.
Primary	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.
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)	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.
Primary	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	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.
Secondary	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.

1 to 10 of 19Source ClinicalTrials.gov

See all 19 registered outcomes

Outcomes19

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	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	The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period.	days	MEAN
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	At Day 1 of 2 year observation period	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.	months	MEDIAN
PRIMARY	Initial Dose of CT-P13 Infusion Administered to Participants	At Day 1 of 2 year observation period	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.	milligram per kilogram	MEDIAN
PRIMARY	Number of Participants by Initial Frequency of CT-P13 Infusion Received	Baseline (Day 1) of 2 year observation period	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.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Total Dose of CT-P13 Infusion Received During Observation Period	During the observation period of 2 years	The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period.	milligram per kilogram	MEDIAN
PRIMARY	Number of Participants With Change in CT-P13 Infusion Dose	During the observation period of 2 years	The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period.	Participants	COUNT_OF_PARTICIPANTS
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)	During the observation period of 2 years	The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	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	The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	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	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.	units on a scale	MEAN
SECONDARY	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	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.	units on a scale	MEAN

1 to 10 of 19Source ClinicalTrials.gov

See all 19 outcomes

Results by group146

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Treatment Persistence With CT-P13 in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA)	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive		404.10	Standard Deviation 291.33	days
Treatment Persistence With CT-P13 in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA)	Participants Who Switched From Remicade to CT-P13		542.30	Standard Deviation 268.55	days
Disease Duration in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), as Recorded on the Day of Inclusion in Study	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Disease Type: RA	52.928	Full Range 0.03 to 563.91	months
Disease Duration in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), as Recorded on the Day of Inclusion in Study	Participants Who Switched From Remicade to CT-P13	Disease Type: RA	189.142	Full Range 12.65 to 400.20	months
Disease Duration in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), as Recorded on the Day of Inclusion in Study	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Disease Type: AS	35.039	Full Range 0.03 to 551.89	months
Disease Duration in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), as Recorded on the Day of Inclusion in Study	Participants Who Switched From Remicade to CT-P13	Disease Type: AS	159.376	Full Range 14.65 to 418.33	months
Disease Duration in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), as Recorded on the Day of Inclusion in Study	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Disease Type: PsA	33.084	Full Range 0.03 to 386.50	months
Disease Duration in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), as Recorded on the Day of Inclusion in Study	Participants Who Switched From Remicade to CT-P13	Disease Type: PsA	133.979	Full Range 18.40 to 464.07	months
Initial Dose of CT-P13 Infusion Administered to Participants	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive		3.00	Full Range 2.40 to 6.20	milligram per kilogram
Initial Dose of CT-P13 Infusion Administered to Participants	Participants Who Switched From Remicade to CT-P13		4.00	Full Range 2.00 to 6.60	milligram per kilogram

1 to 10 of 146Source ClinicalTrials.gov

See all 146 results by group

Participant flow8

How many started, completed or left each group, period by period.

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

Source ClinicalTrials.gov

Adverse events236

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Cardiomyopathy	Cardiac disorders	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	1	221
other	Cardiomyopathy	Cardiac disorders	Participants Who Switched From Remicade to CT-P13	0	107
other	Uveitis	Eye disorders	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	2	221
other	Uveitis	Eye disorders	Participants Who Switched From Remicade to CT-P13	0	107
other	Abdominal distension	Gastrointestinal disorders	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	1	221
other	Abdominal distension	Gastrointestinal disorders	Participants Who Switched From Remicade to CT-P13	0	107
other	Abdominal pain	Gastrointestinal disorders	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	3	221
other	Abdominal pain	Gastrointestinal disorders	Participants Who Switched From Remicade to CT-P13	0	107
other	Aphthous ulcer	Gastrointestinal disorders	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	1	221
other	Aphthous ulcer	Gastrointestinal disorders	Participants Who Switched From Remicade to CT-P13	0	107

1 to 10 of 236Source ClinicalTrials.gov

See all 236 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	0	221
Total, all-cause mortality	Participants Who Switched From Remicade to CT-P13	0	107
Total, other adverse events	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	88	221
Total, other adverse events	Participants Who Switched From Remicade to CT-P13	24	107
Total, serious adverse events	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	19	221
Total, serious adverse events	Participants Who Switched From Remicade to CT-P13	10	107

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34377890	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive vs Participants Who Switched From Remicade to CT-P13: Number of Participants With Change in CT-P13 Infusion Dose	Trial comparisons
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive vs Participants Who Switched From Remicade to CT-P13: deaths from any cause	Trial comparisons
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive vs Participants Who Switched From Remicade to CT-P13: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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