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Trial record 1 of 1 for:    NCT02605642
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Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade (PERSIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02605642
Recruitment Status : Completed
First Posted : November 16, 2015
Results First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Rheumatoid Diseases
Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis
Intervention Drug: CT-P13
Enrollment 351
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.
Pre-assignment Details  
Arm/Group Title Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive Participants Who Switched From Remicade to CT-P13
Hide 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 [1] 221 107
Completed 131 86
Not Completed 96 21
Reason Not Completed
Other             11             1
Participant non-compliance             2             4
Physician Decision             10             0
Lost to Follow-up             12             1
Adverse Event             14             2
Withdrawal by Subject             23             2
Lack of response             24             11
[1]
Included all participants who received at least 1 dose of CT- P13 during study observation period
Arm/Group Title Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive Participants Who Switched From Remicade to CT-P13 Total
Hide 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 Number of Baseline Participants 221 107 328
Hide Baseline Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of CT-P13 during the study observation period.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 221 participants 107 participants 328 participants
53.3  (13.54) 52.5  (12.61) 53.1  (13.23)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 221 participants 107 participants 328 participants
Female
118
  53.4%
48
  44.9%
166
  50.6%
Male
103
  46.6%
59
  55.1%
162
  49.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 221 participants 107 participants 328 participants
White
212
  95.9%
106
  99.1%
318
  97.0%
Black or African American
2
   0.9%
0
   0.0%
2
   0.6%
Asian
6
   2.7%
0
   0.0%
6
   1.8%
Other
1
   0.5%
1
   0.9%
2
   0.6%
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Centimeter
Number Analyzed 220 participants 106 participants 326 participants
168.44  (9.467) 173.19  (10.592) 169.98  (10.080)
[1]
Measure Analysis Population Description: Number analyzed signifies participants evaluable for this baseline measure.
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 221 participants 107 participants 328 participants
80.80  (16.613) 83.21  (19.442) 81.59  (17.592)
Body Mass Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilogram per meter square
Number Analyzed 220 participants 106 participants 326 participants
28.51  (5.521) 27.74  (5.968) 28.26  (5.672)
[1]
Measure Analysis Population Description: Number analyzed signifies participants evaluable for this baseline measure.
Participants with Medical History   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 221 participants 107 participants 328 participants
221
 100.0%
107
 100.0%
328
 100.0%
[1]
Measure Description: Number of participants with at least one clinically relevant medical history/condition (rheumatoid arthritis [RA], ankylosing spondylitis [AS], or psoriatic arthritis [PsA]) were reported.
Surgery Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 221 participants 107 participants 328 participants
Yes
20
   9.0%
12
  11.2%
32
   9.8%
No
201
  91.0%
95
  88.8%
296
  90.2%
[1]
Measure Description: 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.
1.Primary Outcome
Title Treatment Persistence With CT-P13 in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 221 107
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 221 107
Median (Full Range)
Unit of Measure: months
Disease Type: RA Number Analyzed 94 participants 41 participants
52.928
(0.03 to 563.91)
189.142
(12.65 to 400.20)
Disease Type: AS Number Analyzed 78 participants 38 participants
35.039
(0.03 to 551.89)
159.376
(14.65 to 418.33)
Disease Type: PsA Number Analyzed 49 participants 28 participants
33.084
(0.03 to 386.50)
133.979
(18.40 to 464.07)
3.Primary Outcome
Title Initial Dose of CT-P13 Infusion Administered to Participants
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 207 102
Median (Full Range)
Unit of Measure: milligram per kilogram
3.00
(2.40 to 6.20)
4.00
(2.00 to 6.60)
4.Primary Outcome
Title Number of Participants by Initial Frequency of CT-P13 Infusion Received
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 207 102
Measure Type: Count of Participants
Unit of Measure: Participants
Once every 4 weeks
3
   1.4%
1
   1.0%
Once every 6 weeks
79
  38.2%
42
  41.2%
Once every 8 weeks
73
  35.3%
44
  43.1%
Other
52
  25.1%
15
  14.7%
5.Primary Outcome
Title Total Dose of CT-P13 Infusion Received During Observation Period
Hide Description Total dose of infusion received by the participants were evaluated.
Time Frame During the observation period of 2 years
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 221 107
Median (Full Range)
Unit of Measure: milligram per kilogram
35.00
(2.40 to 90.00)
46.50
(3.00 to 112.20)
6.Primary Outcome
Title Number of Participants With Change in CT-P13 Infusion Dose
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 221 107
Measure Type: Count of Participants
Unit of Measure: 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 221 107
Measure Type: Count of Participants
Unit of Measure: Participants
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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 221 107
Measure Type: Count of Participants
Unit of Measure: Participants
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 92 41
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 43 participants 31 participants
4.033  (1.5186) 2.641  (1.1401)
Change at Month 6 Number Analyzed 22 participants 23 participants
-1.269  (1.5981) 0.210  (1.1452)
Change at Month 12 Number Analyzed 14 participants 14 participants
-0.642  (1.1220) -0.432  (1.6097)
Change at Month 18 Number Analyzed 1 participants 5 participants
-0.795 0.534  (0.9656)
Change at Month 24 Number Analyzed 0 participants 0 participants
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 46 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 22 participants 14 participants
3.755  (1.7767) 2.351  (1.0677)
Change at Month 6 Number Analyzed 13 participants 10 participants
-0.913  (1.8785) 0.152  (0.2737)
Change at Month 12 Number Analyzed 4 participants 8 participants
-0.006  (1.7984) 0.259  (0.3916)
Change at Month 18 Number Analyzed 4 participants 4 participants
-0.747  (1.2115) 0.840  (0.9880)
Change at Month 24 Number Analyzed 1 participants 3 participants
-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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 77 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 65 participants 29 participants
4.63  (2.263) 3.06  (2.313)
Change at Month 6 Number Analyzed 58 participants 27 participants
-1.00  (1.911) 0.01  (1.470)
Change at Month 12 Number Analyzed 36 participants 17 participants
-0.87  (1.816) 0.06  (2.304)
Change at Month 18 Number Analyzed 30 participants 11 participants
-0.55  (2.153) -0.24  (2.015)
Change at Month 24 Number Analyzed 11 participants 6 participants
-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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 77 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 32 participants 16 participants
3.153  (1.1082) 2.151  (1.0456)
Change at Month 6 Number Analyzed 18 participants 13 participants
-0.875  (1.3108) -0.023  (1.1017)
Change at Month 12 Number Analyzed 16 participants 9 participants
-0.379  (0.9905) -0.452  (0.8156)
Change at Month 18 Number Analyzed 6 participants 3 participants
-0.603  (2.7745) -0.002  (0.3630)
Change at Month 24 Number Analyzed 6 participants 4 participants
-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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 77 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 63 participants 29 participants
4.17  (2.804) 2.89  (2.492)
Change at Month 6 Number Analyzed 57 participants 27 participants
-0.72  (2.107) 0.20  (1.146)
Change at Month 12 Number Analyzed 35 participants 17 participants
-1.01  (2.085) 0.18  (2.228)
Change at Month 18 Number Analyzed 29 participants 11 participants
-0.43  (2.194) 0.23  (2.257)
Change at Month 24 Number Analyzed 11 participants 6 participants
-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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 215 107
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 181 participants 85 participants
0.956  (0.7493) 0.646  (0.6684)
Change at Month 6 Number Analyzed 162 participants 76 participants
-0.216  (0.5906) 0.026  (0.3648)
Change at Month 12 Number Analyzed 90 participants 52 participants
-0.207  (0.5739) -0.043  (0.5144)
Change at Month 18 Number Analyzed 75 participants 24 participants
-0.150  (0.4650) -0.021  (0.3878)
Change at Month 24 Number Analyzed 22 participants 9 participants
-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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 215 107
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 183 participants 85 participants
62.7  (23.55) 70.0  (22.71)
Change at Month 6 Number Analyzed 163 participants 76 participants
6.0  (25.55) 0.2  (20.66)
Change at Month 12 Number Analyzed 87 participants 52 participants
4.2  (21.93) 1.0  (26.06)
Change at Month 18 Number Analyzed 75 participants 24 participants
-0.8  (28.71) -0.0  (25.98)
Change at Month 24 Number Analyzed 21 participants 9 participants
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 215 107
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 183 participants 85 participants
0.627  (0.2260) 0.757  (0.1906)
Change at Month 6 Number Analyzed 163 participants 76 participants
0.097  (0.2309) 0.004  (0.1859)
Change at Month 12 Number Analyzed 87 participants 52 participants
0.106  (0.2093) -0.002  (0.1900)
Change at Month 18 Number Analyzed 75 participants 24 participants
0.102  (0.1522) -0.041  (0.1416)
Change at Month 24 Number Analyzed 21 participants 9 participants
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 215 107
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 181 participants 85 participants
37.018  (10.1214) 41.865  (10.2835)
Change at Month 6 Number Analyzed 162 participants 76 participants
2.679  (9.5359) 0.638  (7.5793)
Change at Month 12 Number Analyzed 90 participants 52 participants
3.988  (8.6626) 0.683  (8.8907)
Change at Month 18 Number Analyzed 75 participants 24 participants
2.325  (8.1633) 0.295  (11.0411)
Change at Month 24 Number Analyzed 22 participants 9 participants
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 215 107
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 181 participants 85 participants
47.154  (10.9659) 52.152  (9.8788)
Change at Month 6 Number Analyzed 162 participants 76 participants
2.603  (8.9694) -0.412  (8.7364)
Change at Month 12 Number Analyzed 90 participants 52 participants
1.435  (8.1599) 0.119  (8.3434)
Change at Month 18 Number Analyzed 75 participants 24 participants
1.457  (8.0383) -1.145  (9.9283)
Change at Month 24 Number Analyzed 22 participants 9 participants
-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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 215 107
Mean (Standard Deviation)
Unit of Measure: millimeters
Baseline Number Analyzed 176 participants 88 participants
34.9  (27.80) 18.4  (17.27)
Change at Month 6 Number Analyzed 159 participants 74 participants
-13.4  (26.94) 0.6  (18.07)
Change at Month 12 Number Analyzed 91 participants 50 participants
-19.2  (23.17) -1.5  (19.02)
Change at Month 18 Number Analyzed 66 participants 26 participants
-12.5  (20.58) 2.1  (11.75)
Change at Month 24 Number Analyzed 18 participants 11 participants
-25.6  (23.49) -3.4  (12.27)
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
Hide 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 (%) Affected / at Risk (%)
Total   0/221 (0.00%)   0/107 (0.00%) 
Hide Serious Adverse Events
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive Participants Who Switched From Remicade to CT-P13
Affected / at Risk (%) Affected / at Risk (%)
Total   19/221 (8.60%)   10/107 (9.35%) 
Blood and lymphatic system disorders     
Anaemia * 1  0/221 (0.00%)  1/107 (0.93%) 
Cardiac disorders     
Coronary artery stenosis * 1  0/221 (0.00%)  1/107 (0.93%) 
Myocardial infarction * 1  1/221 (0.45%)  0/107 (0.00%) 
Eye disorders     
Uveitis * 1  1/221 (0.45%)  0/107 (0.00%) 
Gastrointestinal disorders     
Pancreatitis * 1  1/221 (0.45%)  0/107 (0.00%) 
Hepatobiliary disorders     
Autoimmune hepatitis * 1  1/221 (0.45%)  0/107 (0.00%) 
Gallbladder polyp * 1  1/221 (0.45%)  0/107 (0.00%) 
Infections and infestations     
Appendicitis * 1  1/221 (0.45%)  0/107 (0.00%) 
Bronchitis * 1  2/221 (0.90%)  0/107 (0.00%) 
Erysipelas * 1  0/221 (0.00%)  1/107 (0.93%) 
Herpes zoster * 1  1/221 (0.45%)  1/107 (0.93%) 
Lower respiratory tract infection * 1  0/221 (0.00%)  1/107 (0.93%) 
Necrotising herpetic retinopathy * 1  1/221 (0.45%)  0/107 (0.00%) 
Pilonidal cyst * 1  0/221 (0.00%)  1/107 (0.93%) 
Pneumonia * 1  0/221 (0.00%)  1/107 (0.93%) 
Tooth abscess * 1  0/221 (0.00%)  1/107 (0.93%) 
Injury, poisoning and procedural complications     
Infusion related reaction * 1  1/221 (0.45%)  0/107 (0.00%) 
Pelvic fracture * 1  1/221 (0.45%)  0/107 (0.00%) 
Metabolism and nutrition disorders     
Hypoglycaemia * 1  0/221 (0.00%)  1/107 (0.93%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal chest pain * 1  1/221 (0.45%)  0/107 (0.00%) 
Osteoarthritis * 1  2/221 (0.90%)  0/107 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Endometrial adenocarcinoma * 1  1/221 (0.45%)  0/107 (0.00%) 
Lip squamous cell carcinoma * 1  1/221 (0.45%)  0/107 (0.00%) 
Transitional cell carcinoma * 1  1/221 (0.45%)  0/107 (0.00%) 
Nervous system disorders     
Paraesthesia * 1  1/221 (0.45%)  0/107 (0.00%) 
Syncope * 1  1/221 (0.45%)  0/107 (0.00%) 
Product Issues     
Device loosening * 1  0/221 (0.00%)  1/107 (0.93%) 
Psychiatric disorders     
Depression * 1  1/221 (0.45%)  0/107 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism * 1  0/221 (0.00%)  1/107 (0.93%) 
Vascular disorders     
Hypertensive crisis * 1  0/221 (0.00%)  1/107 (0.93%) 
Thrombophlebitis * 1  0/221 (0.00%)  1/107 (0.93%) 
1
Term from vocabulary, MedDRA v21.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive Participants Who Switched From Remicade to CT-P13
Affected / at Risk (%) Affected / at Risk (%)
Total   88/221 (39.82%)   24/107 (22.43%) 
Cardiac disorders     
Cardiomyopathy * 1  1/221 (0.45%)  0/107 (0.00%) 
Eye disorders     
Uveitis * 1  2/221 (0.90%)  0/107 (0.00%) 
Gastrointestinal disorders     
Abdominal distension * 1  1/221 (0.45%)  0/107 (0.00%) 
Abdominal pain * 1  3/221 (1.36%)  0/107 (0.00%) 
Aphthous ulcer * 1  1/221 (0.45%)  0/107 (0.00%) 
Dyspepsia * 1  1/221 (0.45%)  0/107 (0.00%) 
General disorders     
Asthenia * 1  1/221 (0.45%)  0/107 (0.00%) 
Cyst * 1  0/221 (0.00%)  1/107 (0.93%) 
Drug ineffective * 1  25/221 (11.31%)  6/107 (5.61%) 
Impaired healing * 1  0/221 (0.00%)  1/107 (0.93%) 
Malaise * 1  1/221 (0.45%)  1/107 (0.93%) 
Nodule * 1  1/221 (0.45%)  0/107 (0.00%) 
Peripheral swelling * 1  1/221 (0.45%)  0/107 (0.00%) 
Pyrexia * 1  1/221 (0.45%)  0/107 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis * 1  0/221 (0.00%)  1/107 (0.93%) 
Gallbladder polyp * 1  1/221 (0.45%)  0/107 (0.00%) 
Hypertransaminasaemia * 1  1/221 (0.45%)  0/107 (0.00%) 
Liver disorder * 1  0/221 (0.00%)  1/107 (0.93%) 
Infections and infestations     
Bronchitis * 1  3/221 (1.36%)  0/107 (0.00%) 
Cystitis * 1  0/221 (0.00%)  1/107 (0.93%) 
Eye infection * 1  0/221 (0.00%)  1/107 (0.93%) 
Febrile infection * 1  1/221 (0.45%)  0/107 (0.00%) 
Herpes virus infection * 1  0/221 (0.00%)  1/107 (0.93%) 
Herpes zoster * 1  1/221 (0.45%)  1/107 (0.93%) 
Influenza * 1  1/221 (0.45%)  0/107 (0.00%) 
Lower respiratory tract infection * 1  2/221 (0.90%)  0/107 (0.00%) 
Nasal herpes * 1  1/221 (0.45%)  1/107 (0.93%) 
Nasopharyngitis * 1  6/221 (2.71%)  1/107 (0.93%) 
Oral herpes * 1  0/221 (0.00%)  2/107 (1.87%) 
Periodontitis * 1  1/221 (0.45%)  0/107 (0.00%) 
Pharyngotonsillitis * 1  0/221 (0.00%)  1/107 (0.93%) 
Pneumonia * 1  3/221 (1.36%)  0/107 (0.00%) 
Respiratory tract infection * 1  1/221 (0.45%)  0/107 (0.00%) 
Sinusitis * 1  1/221 (0.45%)  1/107 (0.93%) 
Tonsillitis * 1  0/221 (0.00%)  1/107 (0.93%) 
Tooth abscess * 1  1/221 (0.45%)  0/107 (0.00%) 
Tooth infection * 1  0/221 (0.00%)  1/107 (0.93%) 
Upper respiratory tract infection * 1  6/221 (2.71%)  4/107 (3.74%) 
Urinary tract infection * 1  0/221 (0.00%)  1/107 (0.93%) 
Viral infection * 1  2/221 (0.90%)  0/107 (0.00%) 
Injury, poisoning and procedural complications     
Epicondylitis * 1  1/221 (0.45%)  0/107 (0.00%) 
Exposure during pregnancy * 1  1/221 (0.45%)  0/107 (0.00%) 
Foot fracture * 1  1/221 (0.45%)  0/107 (0.00%) 
Infusion related reaction * 1  14/221 (6.33%)  2/107 (1.87%) 
Investigations     
Blood pressure increased * 1  1/221 (0.45%)  0/107 (0.00%) 
Drug specific antibody * 1  1/221 (0.45%)  0/107 (0.00%) 
Haemoglobin decreased * 1  0/221 (0.00%)  1/107 (0.93%) 
Hepatic enzyme increased * 1  1/221 (0.45%)  0/107 (0.00%) 
Liver function test increased * 1  1/221 (0.45%)  0/107 (0.00%) 
Mycobacterium tuberculosis complex test positive * 1  1/221 (0.45%)  0/107 (0.00%) 
Metabolism and nutrition disorders     
Vitamin D deficiency * 1  1/221 (0.45%)  0/107 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/221 (0.45%)  0/107 (0.00%) 
Arthritis * 1  1/221 (0.45%)  0/107 (0.00%) 
Back pain * 1  1/221 (0.45%)  1/107 (0.93%) 
Bursitis * 1  1/221 (0.45%)  0/107 (0.00%) 
Chondropathy * 1  0/221 (0.00%)  1/107 (0.93%) 
Intervertebral disc protrusion * 1  1/221 (0.45%)  0/107 (0.00%) 
Joint swelling * 1  1/221 (0.45%)  0/107 (0.00%) 
Muscular weakness * 1  1/221 (0.45%)  0/107 (0.00%) 
Osteoarthritis * 1  1/221 (0.45%)  0/107 (0.00%) 
Pain in extremity * 1  2/221 (0.90%)  0/107 (0.00%) 
Rheumatic disorder * 1  1/221 (0.45%)  0/107 (0.00%) 
Rheumatoid arthritis * 1  0/221 (0.00%)  1/107 (0.93%) 
Synovitis * 1  0/221 (0.00%)  1/107 (0.93%) 
Tendonitis * 1  1/221 (0.45%)  0/107 (0.00%) 
Vertebral foraminal stenosis * 1  0/221 (0.00%)  1/107 (0.93%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma * 1  1/221 (0.45%)  0/107 (0.00%) 
Nervous system disorders     
Headache * 1  6/221 (2.71%)  0/107 (0.00%) 
Hypoaesthesia * 1  1/221 (0.45%)  0/107 (0.00%) 
Intercostal neuralgia * 1  0/221 (0.00%)  1/107 (0.93%) 
Paraesthesia * 1  1/221 (0.45%)  0/107 (0.00%) 
Somnolence * 1  1/221 (0.45%)  0/107 (0.00%) 
Syncope * 1  1/221 (0.45%)  0/107 (0.00%) 
Psychiatric disorders     
Insomnia * 1  1/221 (0.45%)  0/107 (0.00%) 
Renal and urinary disorders     
Renal cyst * 1  1/221 (0.45%)  0/107 (0.00%) 
Renal failure * 1  1/221 (0.45%)  1/107 (0.93%) 
Reproductive system and breast disorders     
Erectile dysfunction * 1  0/221 (0.00%)  1/107 (0.93%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  0/221 (0.00%)  1/107 (0.93%) 
Palmoplantar pustulosis * 1  1/221 (0.45%)  0/107 (0.00%) 
Psoriasis * 1  1/221 (0.45%)  0/107 (0.00%) 
Rash * 1  1/221 (0.45%)  1/107 (0.93%) 
Skin induration * 1  1/221 (0.45%)  0/107 (0.00%) 
Surgical and medical procedures     
Carpal tunnel decompression * 1  1/221 (0.45%)  0/107 (0.00%) 
Varicose vein operation * 1  1/221 (0.45%)  0/107 (0.00%) 
Vascular disorders     
Hypertension * 1  1/221 (0.45%)  0/107 (0.00%) 
Hypotension * 1  1/221 (0.45%)  0/107 (0.00%) 
Peripheral coldness * 1  0/221 (0.00%)  1/107 (0.93%) 
1
Term from vocabulary, MedDRA v21.1
*
Indicates events were collected by 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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 8007181021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02605642    
Other Study ID Numbers: ZOBINF1505
C1231002 ( Other Identifier: Alias Study Number )
First Submitted: September 2, 2015
First Posted: November 16, 2015
Results First Submitted: December 20, 2019
Results First Posted: January 13, 2020
Last Update Posted: January 13, 2020