Trial Outcomes & Findings for Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients (NCT NCT00850343)
NCT ID: NCT00850343
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 275-08-003. 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
208 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 275-08-003 (NCT00791921) were eligible for this study.
Participants were assigned to treatment groups based on whether they discontinued study 275-08-003 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 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks 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 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks 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 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks 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 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
110
|
12
|
43
|
43
|
|
Overall Study
Completed Week 24
|
94
|
12
|
39
|
39
|
|
Overall Study
Completed Week 52
|
88
|
11
|
37
|
37
|
|
Overall Study
COMPLETED
|
64
|
9
|
29
|
30
|
|
Overall Study
NOT COMPLETED
|
46
|
3
|
14
|
13
|
Reasons for withdrawal
| Measure |
Discontinued Non-responders 200 mg
Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks 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 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks 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 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks 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 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
0
|
3
|
2
|
|
Overall Study
Adverse Event
|
15
|
2
|
6
|
6
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
17
|
0
|
3
|
2
|
|
Overall Study
Non-compliance with Study Procedures
|
1
|
0
|
1
|
1
|
|
Overall Study
Physician Decision
|
2
|
1
|
1
|
1
|
Baseline Characteristics
Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients
Baseline characteristics by cohort
| Measure |
Discontinued Non-responders 200 mg
n=110 Participants
Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Non-responders 200 mg
n=12 Participants
Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 200 mg
n=43 Participants
Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 400 mg
n=43 Participants
Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55.4 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
59.3 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
54.6 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 10.7 • n=4 Participants
|
55.5 years
STANDARD_DEVIATION 10.0 • n=21 Participants
|
|
Age, Customized
< 65 years
|
90 participants
n=5 Participants
|
10 participants
n=7 Participants
|
35 participants
n=5 Participants
|
32 participants
n=4 Participants
|
167 participants
n=21 Participants
|
|
Age, Customized
≧ 65 years
|
20 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
11 participants
n=4 Participants
|
41 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
154 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
110 participants
n=5 Participants
|
12 participants
n=7 Participants
|
43 participants
n=5 Participants
|
43 participants
n=4 Participants
|
208 participants
n=21 Participants
|
|
Body Weight
|
56.12 kg
STANDARD_DEVIATION 10.84 • n=5 Participants
|
55.92 kg
STANDARD_DEVIATION 9.55 • n=7 Participants
|
59.36 kg
STANDARD_DEVIATION 11.11 • n=5 Participants
|
58.65 kg
STANDARD_DEVIATION 11.83 • n=4 Participants
|
57.30 kg
STANDARD_DEVIATION 11.06 • 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 275-08-003. 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=110 Participants
Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Non-responders 200 mg
n=12 Participants
Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 200 mg
n=43 Participants
Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 400 mg
n=43 Participants
Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks 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
|
102 participants
|
12 participants
|
41 participants
|
40 participants
|
|
Number of Participants With Adverse Events
Mild adverse events
|
16 participants
|
4 participants
|
7 participants
|
15 participants
|
|
Number of Participants With Adverse Events
Moderate adverse events
|
70 participants
|
6 participants
|
23 participants
|
18 participants
|
|
Number of Participants With Adverse Events
Severe adverse events
|
16 participants
|
2 participants
|
11 participants
|
7 participants
|
|
Number of Participants With Adverse Events
Serious adverse events
|
40 participants
|
3 participants
|
17 participants
|
16 participants
|
|
Number of Participants With Adverse Events
Serious adverse events leading to death
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Non-fatal serious adverse events
|
40 participants
|
2 participants
|
16 participants
|
16 participants
|
|
Number of Participants With Adverse Events
Adverse events leading to withdrawal
|
16 participants
|
2 participants
|
6 participants
|
6 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
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline (of Study 275-08-003), 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 275-08-003) 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=110 Participants
Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Non-responders 200 mg
n=12 Participants
Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 200 mg
n=43 Participants
Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 400 mg
n=43 Participants
Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks 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
|
60.9 percentage of participants
Interval 51.1 to 70.1
|
58.3 percentage of participants
Interval 27.7 to 84.8
|
90.7 percentage of participants
Interval 77.9 to 97.4
|
90.7 percentage of participants
Interval 77.9 to 97.4
|
|
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response
Week 52
|
70.0 percentage of participants
Interval 60.5 to 78.4
|
83.3 percentage of participants
Interval 51.6 to 97.9
|
76.7 percentage of participants
Interval 61.4 to 88.2
|
90.7 percentage of participants
Interval 77.9 to 97.4
|
|
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response
Final Assessment
|
67.3 percentage of participants
Interval 57.7 to 75.9
|
75.0 percentage of participants
Interval 42.8 to 94.5
|
86.0 percentage of participants
Interval 72.1 to 94.7
|
88.4 percentage of participants
Interval 74.9 to 96.1
|
SECONDARY outcome
Timeframe: Baseline (of Study 275-08-003), 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 275-08-003) 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=110 Participants
Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Non-responders 200 mg
n=12 Participants
Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 200 mg
n=43 Participants
Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 400 mg
n=43 Participants
Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks 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
|
29.1 percentage of participants
Interval 20.8 to 38.5
|
41.7 percentage of participants
Interval 15.2 to 72.3
|
69.8 percentage of participants
Interval 53.9 to 82.8
|
74.4 percentage of participants
Interval 58.5 to 86.5
|
|
Percentage of Participants With American College of Rheumatology 50% (ACR50) Response
Week 52
|
40.9 percentage of participants
Interval 31.6 to 50.7
|
58.3 percentage of participants
Interval 27.7 to 84.8
|
62.8 percentage of participants
Interval 46.7 to 77.0
|
69.8 percentage of participants
Interval 53.9 to 82.8
|
|
Percentage of Participants With American College of Rheumatology 50% (ACR50) Response
Final Assessment
|
47.3 percentage of participants
Interval 37.7 to 57.0
|
58.3 percentage of participants
Interval 27.7 to 84.8
|
67.4 percentage of participants
Interval 51.5 to 80.9
|
74.4 percentage of participants
Interval 58.8 to 86.5
|
SECONDARY outcome
Timeframe: Baseline (of Study 275-08-003), 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 275-08-003) 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=110 Participants
Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Non-responders 200 mg
n=12 Participants
Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 200 mg
n=43 Participants
Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 400 mg
n=43 Participants
Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks 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
|
14.5 percentage of participants
Interval 8.5 to 22.5
|
16.7 percentage of participants
Interval 2.1 to 48.4
|
46.5 percentage of participants
Interval 31.2 to 62.3
|
48.8 percentage of participants
Interval 33.3 to 64.5
|
|
Percentage of Participants With American College of Rheumatology 70% (ACR70) Response
Week 52
|
22.7 percentage of participants
Interval 15.3 to 31.7
|
16.7 percentage of participants
Interval 2.1 to 48.4
|
58.1 percentage of participants
Interval 42.1 to 73.0
|
46.5 percentage of participants
Interval 31.2 to 62.3
|
|
Percentage of Participants With American College of Rheumatology 70% (ACR70) Response
Final Assessment
|
29.1 percentage of participants
Interval 20.8 to 38.5
|
16.7 percentage of participants
Interval 2.1 to 48.4
|
60.5 percentage of participants
Interval 44.4 to 75.0
|
58.1 percentage of participants
Interval 42.1 to 73.0
|
SECONDARY outcome
Timeframe: Baseline (of Study 275-08-003), 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. "N" indicates the number of participants with available data at each time point.
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 275-08-003 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=110 Participants
Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Non-responders 200 mg
n=12 Participants
Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 200 mg
n=43 Participants
Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 400 mg
n=43 Participants
Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks 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 [N=110, 12, 43, 43]
|
-1.87 units on a scale
Standard Deviation 1.31
|
-2.46 units on a scale
Standard Deviation 1.18
|
-3.10 units on a scale
Standard Deviation 1.28
|
-2.87 units on a scale
Standard Deviation 1.40
|
|
Change From Baseline in Disease Activity Score (DAS) 28
Week 52 [N=109, 12, 43, 43]
|
-2.15 units on a scale
Standard Deviation 1.37
|
-2.53 units on a scale
Standard Deviation 0.90
|
-2.93 units on a scale
Standard Deviation 1.47
|
-2.98 units on a scale
Standard Deviation 1.11
|
|
Change From Baseline in Disease Activity Score (DAS) 28
Final Assessment [N=110, 12, 43, 43]
|
-2.23 units on a scale
Standard Deviation 1.63
|
-2.31 units on a scale
Standard Deviation 1.21
|
-2.98 units on a scale
Standard Deviation 1.58
|
-2.93 units on a scale
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: Baseline (of Study 275-08-003), 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=87 Participants
Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Non-responders 200 mg
n=11 Participants
Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 200 mg
n=37 Participants
Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 400 mg
n=37 Participants
Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks 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 2.67
|
2.18 units on a scale
Standard Deviation 2.91
|
0.77 units on a scale
Standard Deviation 3.00
|
-0.05 units on a scale
Standard Deviation 1.22
|
|
Change From Baseline in Modified Total Sharp Score (mTSS)
Change from Baseline to Week 100 [N=82, 11, 35, 36
|
7.89 units on a scale
Standard Deviation 14.23
|
8.73 units on a scale
Standard Deviation 11.54
|
2.07 units on a scale
Standard Deviation 6.72
|
1.85 units on a scale
Standard Deviation 4.24
|
Adverse Events
Discontinued Non-responders 200 mg
Serious events: 40 serious events
Other events: 102 other events
Deaths: 0 deaths
Completed Non-responders 200 mg
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Completed Responders 200 mg
Serious events: 17 serious events
Other events: 41 other events
Deaths: 0 deaths
Completed Responders 400 mg
Serious events: 16 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Discontinued Non-responders 200 mg
n=110 participants at risk
Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Non-responders 200 mg
n=12 participants at risk
Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 200 mg
n=43 participants at risk
Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 400 mg
n=43 participants at risk
Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
|---|---|---|---|---|
|
General disorders
Pyrexia
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Liver disorder
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Acute sinusitis
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Aspergillosis
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
1.8%
2/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Acute myocardial infarction
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Angina pectoris
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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 infraction
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Pericarditis
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Cardiac disorder
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Deafness neurosensory
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Colitis
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Colonic polyp
|
1.8%
2/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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 ulcer
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Peritonitis
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Upper gastrointestinal haemorrhage
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Haemorrhoidal haemorrhage
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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 discomfort
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Postoperative wound infection
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Pyothorax
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Septic shock
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Wound infection
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Arthritis bacterial
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Staphylococcal sepsis
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Psoas abscess
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
1.8%
2/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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 oticus
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Foot fracture
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Radius fracture
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
1.8%
2/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Tibia fracture
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Meniscus lesion
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Procedural pain
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Ankylosing spondylitis
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Arthropathy
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
3.6%
4/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Scoliosis
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Intervertebral disc protrusion
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Wrist deformity
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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)
Adenoma benign
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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)
Lymphoma
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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 pleural effusion
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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)
Non-Hodgkin's lymphoma
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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 adenoma
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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)
Hepatic cancer metastatic
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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)
Lung neoplasm malignant
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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 neoplasm
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Brain stem haemorrhage
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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 infarction
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Dizziness postural
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Migraine
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Multiple sclerosis
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Thoracic outlet syndrome
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Completed suicide
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Depression
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Anxiety disorder
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Calculus ureteric
|
1.8%
2/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
1.8%
2/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Pleural effusion
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Dermal cyst
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
|
Social circumstances
Overwork
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Joint arthroplasty
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Aortic aneurysm
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Aortic dissection
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Lymphoedema
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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=110 participants at risk
Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Non-responders 200 mg
n=12 participants at risk
Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 200 mg
n=43 participants at risk
Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
Completed Responders 400 mg
n=43 participants at risk
Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
3.6%
4/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
2.7%
3/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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 positional
|
1.8%
2/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Blepharitis
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
9.3%
4/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
1.8%
2/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
4.5%
5/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
9.3%
4/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
7.3%
8/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
9.3%
4/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Diplopia
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Keratitis
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
2.7%
3/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Colonic polyp
|
1.8%
2/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
12.7%
14/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
16.7%
2/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
6.4%
7/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
8.2%
9/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
16.7%
2/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Dyspepsia
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
6.4%
7/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
9.3%
4/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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 atrophic
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
2.7%
3/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
9.3%
4/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
10.0%
11/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
5.5%
6/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
5.5%
6/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
11.6%
5/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
3.6%
4/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
16.7%
2/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Mass
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
8.2%
9/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
16.7%
2/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
2.7%
3/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
11.6%
5/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Liver disorder
|
1.8%
2/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Gallbladder polyp
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
11.8%
13/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
10.9%
12/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
16.7%
2/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
18.6%
8/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
14.0%
6/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
2.7%
3/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
8.2%
9/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
7.3%
8/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
7.3%
8/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
9.3%
4/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
6.4%
7/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
38.2%
42/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
16.7%
2/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
41.9%
18/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
44.2%
19/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Oesophageal candidiasis
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
16.7%
2/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Paronychia
|
1.8%
2/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
15.5%
17/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
16.3%
7/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
16.3%
7/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
4.5%
5/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
16.7%
2/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
9.3%
4/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
6.4%
7/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
7.3%
8/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
9.3%
4/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
12.7%
14/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
16.7%
2/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
20.9%
9/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
9.3%
4/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
1.8%
2/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
6.4%
7/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
3.6%
4/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
9.3%
4/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Dislocation of vertebra
|
1.8%
2/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
5.5%
6/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Vaccination complication
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
10.9%
12/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
14.0%
6/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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 creatinine increased
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Chest X-ray abnormal
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
4.5%
5/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
9.3%
4/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
13.6%
15/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
25.0%
3/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
14.0%
6/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
14.0%
6/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
2.7%
3/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Tenosynovitis
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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 nodule
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Lower extremity mass
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Intervertebral disc protrusion
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Musculoskeletal stiffness
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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)
Conjunctival neoplasm
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
5.5%
6/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
6.4%
7/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
16.3%
7/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Sleep disorder
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Calculus urinary
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Hypertonic bladder
|
0.91%
1/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Asthma
|
1.8%
2/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Pleurisy
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
2.7%
3/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
16.7%
2/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
9.3%
4/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
4.5%
5/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
11.6%
5/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Dermal cyst
|
2.7%
3/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
6.4%
7/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
14.0%
6/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
14.0%
6/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Drug eruption
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
18.2%
20/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
16.7%
2/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
27.9%
12/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
11.6%
5/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
2.7%
3/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
11.6%
5/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
3.6%
4/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
9.3%
4/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
7.3%
8/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
11.6%
5/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
10.9%
12/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Seborrhoeic dermatitis
|
1.8%
2/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Urticaria
|
4.5%
5/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
2.3%
1/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
Aortic aneurysm
|
0.00%
0/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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%
0/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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
|
10.0%
11/110 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
8.3%
1/12 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
4.7%
2/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
|
7.0%
3/43 • From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration 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