Trial Outcomes & Findings for Long-term Treatment Study of Certolizumab Pegol (CDP870) as Add-on Medication to Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients (NCT NCT00851318)
NCT ID: NCT00851318
Last Updated: 2014-11-03
Results Overview
An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which did not necessarily have a causal relationship with the treatment. In this study, events that occurred between the time of informed consent and the start of study medication were included in the adverse events for Study 275-08-001. Any event existing prior to the initiation of study treatment that was aggravated after initiation of study treatment was handled as a new event. The investigator assessed the severity of each AE as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A serious adverse event is an AE that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
285 participants
Primary outcome timeframe
From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
Results posted on
2014-11-03
Participant Flow
Patients with rheumatoid arthritis (RA) who participated in Study 275-08-001 (NCT00791999) were eligible for this study.
Participants were assigned to treatment groups based on whether they discontinued study 275-08-001 at Week 16 or completed Week 24 and based on American College of Rheumatology 20% (ACR20) response at Week 24.
Participant milestones
| Measure |
Discontinued Non-responders 200 mg
Participants who were ACR20 non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Non-responders 200 mg
Participants who were ACR20 non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 200 mg
Participants who were ACR20 responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 400 mg
Participants who were ACR20 responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
81
|
19
|
93
|
92
|
|
Overall Study
Completed Week 24
|
69
|
17
|
90
|
87
|
|
Overall Study
Completed Week 52
|
64
|
16
|
87
|
85
|
|
Overall Study
COMPLETED
|
51
|
14
|
72
|
73
|
|
Overall Study
NOT COMPLETED
|
30
|
5
|
21
|
19
|
Reasons for withdrawal
| Measure |
Discontinued Non-responders 200 mg
Participants who were ACR20 non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Non-responders 200 mg
Participants who were ACR20 non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 200 mg
Participants who were ACR20 responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 400 mg
Participants who were ACR20 responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
1
|
5
|
3
|
|
Overall Study
Adverse Event
|
13
|
2
|
9
|
12
|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
8
|
2
|
4
|
2
|
|
Overall Study
Non-compliance with Study Procedures
|
2
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Long-term Treatment Study of Certolizumab Pegol (CDP870) as Add-on Medication to Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients
Baseline characteristics by cohort
| Measure |
Discontinued Non-responders 200 mg
n=81 Participants
Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Non-responders 200 mg
n=19 Participants
Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 200 mg
n=93 Participants
Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 400 mg
n=92 Participants
Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Total
n=285 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51.8 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
51.3 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
52.9 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
54.1 years
STANDARD_DEVIATION 11.0 • n=4 Participants
|
52.8 years
STANDARD_DEVIATION 11.1 • n=21 Participants
|
|
Age, Customized
< 65 years
|
72 participants
n=5 Participants
|
16 participants
n=7 Participants
|
81 participants
n=5 Participants
|
76 participants
n=4 Participants
|
245 participants
n=21 Participants
|
|
Age, Customized
≧ 65 years
|
9 participants
n=5 Participants
|
3 participants
n=7 Participants
|
12 participants
n=5 Participants
|
16 participants
n=4 Participants
|
40 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
236 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
81 participants
n=5 Participants
|
19 participants
n=7 Participants
|
93 participants
n=5 Participants
|
92 participants
n=4 Participants
|
285 participants
n=21 Participants
|
|
Body Weight
|
56.30 kg
STANDARD_DEVIATION 12.00 • n=5 Participants
|
54.27 kg
STANDARD_DEVIATION 9.57 • n=7 Participants
|
55.81 kg
STANDARD_DEVIATION 11.34 • n=5 Participants
|
54.92 kg
STANDARD_DEVIATION 9.47 • n=4 Participants
|
55.56 kg
STANDARD_DEVIATION 10.83 • n=21 Participants
|
PRIMARY outcome
Timeframe: From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.Population: All participants who received at least one study drug administration were included in the safety analysis population (SAF).
An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which did not necessarily have a causal relationship with the treatment. In this study, events that occurred between the time of informed consent and the start of study medication were included in the adverse events for Study 275-08-001. Any event existing prior to the initiation of study treatment that was aggravated after initiation of study treatment was handled as a new event. The investigator assessed the severity of each AE as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A serious adverse event is an AE that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect.
Outcome measures
| Measure |
Discontinued Non-responders 200 mg
n=81 Participants
Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Non-responders 200 mg
n=19 Participants
Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 200 mg
n=93 Participants
Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 400 mg
n=92 Participants
Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events
Any adverse event
|
77 participants
|
18 participants
|
92 participants
|
90 participants
|
|
Number of Participants With Adverse Events
Mild adverse events
|
20 participants
|
4 participants
|
36 participants
|
33 participants
|
|
Number of Participants With Adverse Events
Moderate adverse events
|
47 participants
|
12 participants
|
47 participants
|
45 participants
|
|
Number of Participants With Adverse Events
Severe adverse events
|
10 participants
|
2 participants
|
9 participants
|
12 participants
|
|
Number of Participants With Adverse Events
Serious adverse events (SAE)
|
21 participants
|
4 participants
|
20 participants
|
23 participants
|
|
Number of Participants With Adverse Events
Serious adverse events leading to death
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Non-fatal serious adverse events
|
21 participants
|
4 participants
|
20 participants
|
23 participants
|
|
Number of Participants With Adverse Events
Adverse events leading to withdrawal
|
13 participants
|
2 participants
|
9 participants
|
12 participants
|
|
Number of Participants With Adverse Events
Infections induced by pathogen in study drug
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Overdoses
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Adverse events occurring within 2 hours of dosing
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)Population: The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.
A participant was an ACR20 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-001) were met: * ≥ 20% improvement in 68 tender joint count; * ≥ 20% improvement in 66 swollen joint count; and * ≥ 20% improvement in at least 3 of the 5 following parameters: * Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a 100 mm VAS); * Physician's global assessment of disease activity (measured on a 100 mm VAS); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); * C-Reactive Protein (CRP).
Outcome measures
| Measure |
Discontinued Non-responders 200 mg
n=81 Participants
Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Non-responders 200 mg
n=19 Participants
Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 200 mg
n=93 Participants
Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 400 mg
n=92 Participants
Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
|---|---|---|---|---|
|
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response
Week 24
|
71.6 percentage of participants
Interval 60.5 to 81.1
|
68.4 percentage of participants
Interval 43.4 to 87.4
|
96.8 percentage of participants
Interval 90.9 to 99.3
|
98.9 percentage of participants
Interval 94.1 to 100.0
|
|
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response
Week 52
|
76.5 percentage of participants
Interval 65.8 to 85.2
|
84.2 percentage of participants
Interval 60.4 to 96.6
|
98.9 percentage of participants
Interval 94.2 to 100.0
|
94.6 percentage of participants
Interval 87.8 to 98.2
|
|
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response
Final Assessment
|
80.2 percentage of participants
Interval 69.9 to 88.3
|
89.5 percentage of participants
Interval 66.9 to 98.7
|
95.7 percentage of participants
Interval 89.4 to 98.8
|
94.6 percentage of participants
Interval 87.8 to 98.2
|
SECONDARY outcome
Timeframe: Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)Population: The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.
A participant was an ACR50 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-001) were met: * ≥ 50% improvement in 68 tender joint count; * ≥ 50% improvement in 66 swollen joint count; and * ≥ 50% improvement in at least 3 of the 5 following parameters: * Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a 100 mm VAS); * Physician's global assessment of disease activity (measured on a 100 mm VAS); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); * C-Reactive Protein (CRP).
Outcome measures
| Measure |
Discontinued Non-responders 200 mg
n=81 Participants
Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Non-responders 200 mg
n=19 Participants
Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 200 mg
n=93 Participants
Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 400 mg
n=92 Participants
Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
|---|---|---|---|---|
|
Percentage of Participants With American College of Rheumatology 50% (ACR50) Response
Week 24
|
42.0 percentage of participants
Interval 31.1 to 53.5
|
36.8 percentage of participants
Interval 16.3 to 61.6
|
83.9 percentage of participants
Interval 74.8 to 90.7
|
82.6 percentage of participants
Interval 73.3 to 89.7
|
|
Percentage of Participants With American College of Rheumatology 50% (ACR50) Response
Week 52
|
48.1 percentage of participants
Interval 36.9 to 59.5
|
57.9 percentage of participants
Interval 33.5 to 79.7
|
87.1 percentage of participants
Interval 78.5 to 93.2
|
88.0 percentage of participants
Interval 79.6 to 93.9
|
|
Percentage of Participants With American College of Rheumatology 50% (ACR50) Response
Final Assessment
|
60.5 percentage of participants
Interval 49.0 to 71.2
|
57.9 percentage of participants
Interval 33.5 to 79.7
|
86.0 percentage of participants
Interval 77.3 to 92.3
|
85.9 percentage of participants
Interval 77.0 to 92.3
|
SECONDARY outcome
Timeframe: Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)Population: The full analysis set (FAS) included all randomized participants who received at least one dose of study drug, with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.
A participant was an ACR70 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-001) were met: * ≥ 70% improvement in 68 tender joint count; * ≥ 70% improvement in 66 swollen joint count; and * ≥ 70% improvement in at least 3 of the 5 following parameters: * Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a 100 mm VAS); * Physician's global assessment of disease activity (measured on a 100 mm VAS); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); * C-Reactive Protein (CRP).
Outcome measures
| Measure |
Discontinued Non-responders 200 mg
n=81 Participants
Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Non-responders 200 mg
n=19 Participants
Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 200 mg
n=93 Participants
Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 400 mg
n=92 Participants
Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
|---|---|---|---|---|
|
Percentage of Participants With American College of Rheumatology 70% (ACR70) Response
Week 24
|
14.8 percentage of participants
Interval 7.9 to 24.4
|
26.3 percentage of participants
Interval 9.1 to 51.2
|
60.2 percentage of participants
Interval 49.5 to 70.2
|
47.8 percentage of participants
Interval 37.3 to 58.5
|
|
Percentage of Participants With American College of Rheumatology 70% (ACR70) Response
Week 52
|
30.9 percentage of participants
Interval 21.1 to 42.1
|
31.6 percentage of participants
Interval 12.6 to 56.6
|
64.5 percentage of participants
Interval 53.9 to 74.2
|
57.6 percentage of participants
Interval 46.9 to 67.9
|
|
Percentage of Participants With American College of Rheumatology 70% (ACR70) Response
Final Assessment
|
44.4 percentage of participants
Interval 33.4 to 55.9
|
31.6 percentage of participants
Interval 12.6 to 56.6
|
65.6 percentage of participants
Interval 55.0 to 75.1
|
62.0 percentage of participants
Interval 51.2 to 71.9
|
SECONDARY outcome
Timeframe: Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)Population: The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.
The DAS28 measures the severity of disease at a specific time and is derived from the following variables: * 28 tender joint count; * 28 swollen joint count; * Erythrocyte sedimentation rate (ESR); * Patient's global assessment of disease activity. To obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined. The data before study drug administration of 275-08-001 Study was utilized for Baseline. DAS28(ESR) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible ESR. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score of 3.2 or less indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.
Outcome measures
| Measure |
Discontinued Non-responders 200 mg
n=81 Participants
Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Non-responders 200 mg
n=19 Participants
Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 200 mg
n=93 Participants
Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 400 mg
n=92 Participants
Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score (DAS) 28
Week 24
|
-2.28 units on a scale
Standard Deviation 1.27
|
-2.32 units on a scale
Standard Deviation 1.25
|
-3.24 units on a scale
Standard Deviation 1.11
|
-3.23 units on a scale
Standard Deviation 1.24
|
|
Change From Baseline in Disease Activity Score (DAS) 28
Week 52
|
-2.65 units on a scale
Standard Deviation 1.44
|
-2.34 units on a scale
Standard Deviation 0.96
|
-3.51 units on a scale
Standard Deviation 1.15
|
-3.21 units on a scale
Standard Deviation 1.29
|
|
Change From Baseline in Disease Activity Score (DAS) 28
Final Assessment
|
-2.98 units on a scale
Standard Deviation 1.82
|
-2.67 units on a scale
Standard Deviation 1.44
|
-3.49 units on a scale
Standard Deviation 1.27
|
-3.46 units on a scale
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: Baseline (of Study 275-08-001), Week 0 (of this study) and Week 100Population: Full analysis set with available mTSS data. Linear extrapolation method was used.
X-ray images of extremities (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by at least two radiographic readers. The degree of joint destruction was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints. The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst).
Outcome measures
| Measure |
Discontinued Non-responders 200 mg
n=64 Participants
Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Non-responders 200 mg
n=16 Participants
Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 200 mg
n=86 Participants
Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 400 mg
n=83 Participants
Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
|---|---|---|---|---|
|
Change From Baseline in Modified Total Sharp Score (mTSS)
Change from Baseline to Week 0
|
1.48 units on a scale
Standard Deviation 2.70
|
1.69 units on a scale
Standard Deviation 2.29
|
0.71 units on a scale
Standard Deviation 2.75
|
0.08 units on a scale
Standard Deviation 1.83
|
|
Change From Baseline in Modified Total Sharp Score (mTSS)
Change from Baseline to Week 100 (N=61, 16, 83, 83
|
5.13 units on a scale
Standard Deviation 11.76
|
4.97 units on a scale
Standard Deviation 8.79
|
3.77 units on a scale
Standard Deviation 12.43
|
2.12 units on a scale
Standard Deviation 9.55
|
Adverse Events
Discontinued Non-responders 200 mg
Serious events: 21 serious events
Other events: 77 other events
Deaths: 0 deaths
Completed Non-responders 200 mg
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
Completed Responders 200 mg
Serious events: 20 serious events
Other events: 91 other events
Deaths: 0 deaths
Completed Responders 400 mg
Serious events: 23 serious events
Other events: 90 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Discontinued Non-responders 200 mg
n=81 participants at risk
Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Non-responders 200 mg
n=19 participants at risk
Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 200 mg
n=93 participants at risk
Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 400 mg
n=92 participants at risk
Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Cardiac disorders
Myocardial ischaemia
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Cardiac disorders
Sick sinus syndrome
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Eye disorders
Cataract
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Gastrointestinal disorders
Ileus paralytic
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
General disorders
Chest Pain
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Hepatobiliary disorders
Hepatic steatosis
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Bronchitis
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Bronchopneumonia
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Influenza
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Pneumonia
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.2%
2/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Pyomyositis
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Subcutaneous abscess
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Urinary tract infection
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Abscess limb
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Infective tenosynovitis
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Atypical mycobacterial infection
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.2%
2/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Injury, poisoning and procedural complications
Contusion
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Investigations
Computerised tomogram thorax abnormal
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
3.3%
3/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Musculoskeletal and connective tissue disorders
Joint destruction
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.3%
4/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal sinus cancer
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.2%
2/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Nervous system disorders
Convulsion
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Nervous system disorders
Dementia
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Nervous system disorders
Facial palsy
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Nervous system disorders
Intracranial aneurysm
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.2%
2/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mass
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Surgical and medical procedures
Removal of internal fixation
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Surgical and medical procedures
Toe operation
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
Other adverse events
| Measure |
Discontinued Non-responders 200 mg
n=81 participants at risk
Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Non-responders 200 mg
n=19 participants at risk
Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 200 mg
n=93 participants at risk
Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 400 mg
n=92 participants at risk
Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
3.7%
3/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.6%
8/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.4%
5/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Ear and labyrinth disorders
Vertigo
|
2.5%
2/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
10.5%
2/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.2%
2/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.2%
2/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Endocrine disorders
Anovulatory cycle
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Eye disorders
Cataract
|
3.7%
3/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.4%
5/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
3.3%
3/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Eye disorders
Conjunctivitis allergic
|
9.9%
8/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.6%
8/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.7%
8/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Eye disorders
Diabetic retinopathy
|
2.5%
2/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Eye disorders
Dry eye
|
2.5%
2/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
10.5%
2/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.3%
4/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.2%
2/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
5/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
3.3%
3/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Gastrointestinal disorders
Constipation
|
12.3%
10/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
10.5%
2/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.2%
2/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
9.8%
9/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Gastrointestinal disorders
Dental caries
|
9.9%
8/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
9.7%
9/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
6.5%
6/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
5/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
10.5%
2/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
6.5%
6/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
9.8%
9/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Gastrointestinal disorders
Duodenal polyp
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Gastrointestinal disorders
Enterocolitis
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
6.5%
6/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.2%
2/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Gastrointestinal disorders
Gastric ulcer
|
2.5%
2/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.2%
2/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Gastrointestinal disorders
Gastritis
|
6.2%
5/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
10.5%
2/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
3.2%
3/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.6%
7/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
10.5%
2/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.2%
2/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.2%
2/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Gastrointestinal disorders
Nausea
|
2.5%
2/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.3%
4/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
3.3%
3/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Gastrointestinal disorders
Periodontitis
|
6.2%
5/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
10.5%
2/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.6%
8/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.3%
4/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
2.5%
2/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
3.2%
3/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
6.5%
6/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Gastrointestinal disorders
Stomach discomfort
|
2.5%
2/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
6.5%
6/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
6.5%
6/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Gastrointestinal disorders
Stomatitis
|
8.6%
7/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
3.2%
3/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.7%
8/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
15.8%
3/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
3.2%
3/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
6.5%
6/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
General disorders
Asthenia
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
General disorders
Chest pain
|
3.7%
3/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.2%
2/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.2%
2/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
General disorders
Cyst
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
General disorders
Injection site reaction
|
7.4%
6/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
General disorders
Pyrexia
|
4.9%
4/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.2%
2/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
7.4%
6/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
10.8%
10/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.6%
7/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Hepatobiliary disorders
Hepatic steatosis
|
7.4%
6/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.4%
5/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.3%
4/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Immune system disorders
Seasonal allergy
|
6.2%
5/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
10.8%
10/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
6.5%
6/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Bronchitis
|
12.3%
10/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
21.1%
4/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
15.1%
14/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.7%
8/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.2%
2/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
3.3%
3/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Cystitis
|
8.6%
7/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
10.5%
2/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
6.5%
6/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.3%
4/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Gastroenteritis
|
4.9%
4/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
9.7%
9/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
6.5%
6/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Herpes simplex
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
3.3%
3/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Herpes zoster
|
2.5%
2/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
10.5%
2/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
3.2%
3/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.3%
4/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Influenza
|
8.6%
7/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
9.7%
9/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.6%
7/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Localised infection
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Nasal vestibulitis
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Nasopharyngitis
|
50.6%
41/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
63.2%
12/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
57.0%
53/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
48.9%
45/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
10.5%
2/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
3.2%
3/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
3.3%
3/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Pharyngitis
|
18.5%
15/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
19.4%
18/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
10.9%
10/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Pneumonia
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
3.3%
3/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Sinusitis
|
4.9%
4/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.2%
2/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.4%
5/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Tinea pedis
|
6.2%
5/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.3%
4/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
9.8%
9/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Upper respiratory tract infection
|
18.5%
15/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
15.8%
3/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
21.5%
20/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
21.7%
20/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Urinary tract infection
|
3.7%
3/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Tinea infection
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.4%
5/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.2%
2/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Infections and infestations
Oral herpes
|
7.4%
6/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.5%
7/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
6.5%
6/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
4.9%
4/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
3.2%
3/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.2%
2/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Injury, poisoning and procedural complications
Chillblains
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
10.5%
2/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
3.2%
3/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.2%
2/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.4%
5/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.2%
2/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Injury, poisoning and procedural complications
Contusion
|
11.1%
9/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
12.9%
12/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
6.5%
6/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.2%
2/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.2%
2/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Injury, poisoning and procedural complications
Device failure
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
10.5%
2/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Injury, poisoning and procedural complications
Bone fissure
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Investigations
Alanine aminotransferase increased
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Investigations
Blood pressure increased
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.5%
2/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
10.5%
2/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
7.4%
6/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
6.5%
6/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.3%
4/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.3%
4/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.4%
5/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
5/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
15.8%
3/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.5%
7/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.7%
8/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
7.4%
6/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
21.1%
4/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
10.8%
10/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
14.1%
13/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
2.5%
2/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
2.5%
2/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
6.5%
6/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
3.3%
3/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
2.5%
2/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Nervous system disorders
Headache
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
15.8%
3/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.2%
2/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.4%
5/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.2%
2/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Psychiatric disorders
Insomnia
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.4%
5/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Psychiatric disorders
Psychosomatic disease
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
3/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
3.2%
3/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
6.5%
6/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
4.9%
4/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.6%
8/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.6%
7/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
3.7%
3/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.3%
4/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.4%
5/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
8.6%
7/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
6.5%
6/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
6.5%
6/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
11.1%
9/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
10.5%
2/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
15.1%
14/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
13.0%
12/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
21.1%
4/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.3%
4/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.2%
2/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
1.2%
1/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.2%
2/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
8.6%
7/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.5%
7/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
3.3%
3/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
2.5%
2/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.7%
3/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
3.3%
3/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
5/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
15.8%
3/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.5%
7/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.7%
8/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Skin and subcutaneous tissue disorders
Asteatosis
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
3.3%
3/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Vascular disorders
Hypertension
|
6.2%
5/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
10.5%
2/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
9.7%
9/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
12.0%
11/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
1.1%
1/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Vascular disorders
Hot flush
|
0.00%
0/81 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
5.3%
1/19 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/93 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
0.00%
0/92 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication to ensure that no confidential information of Sponsor is included in the document. Sponsor may delay the publication to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER