Trial Outcomes & Findings for An Open-label Extension Study of Certolizumab Pegol in Chinese Patients With Rheumatoid Arthritis Who Enrolled in RA0044 (NCT NCT02319642)
NCT ID: NCT02319642
Last Updated: 2018-10-16
Results Overview
TEAEs are defined as Advere Events (AEs) starting on or after the date of first study medication administration in this Open-label Extension (OLE) study up to 70 days post-last dose.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
347 participants
Primary outcome timeframe
Baseline to the end of observation period (32 weeks)
Results posted on
2018-10-16
Participant Flow
This study started to enroll subjects in November 2014 and concluded in December 2016.
Participant Flow refers to the Safety Set consisting of all subjects who were dispensed medication.
Participant milestones
| Measure |
Open-label Cimzia (Placebo in Feeder Study)
Subjects were treated with Placebo in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects received either CZP 400 mg subcutaneously (sc) at Weeks 0, 2, and 4 followed by CZP 200 mg sc every two weeks (Q2W) if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
|
Open-label Cimzia (Cimzia in Feeder Study)
Subjects were treated with CZP in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects receive either CZP 400 mg sc at Weeks 0, 2, and 4 followed by CZP 200 mg sc Q2W if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
|
|---|---|---|
|
Overall Study
STARTED
|
95
|
251
|
|
Overall Study
COMPLETED
|
91
|
245
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
Open-label Cimzia (Placebo in Feeder Study)
Subjects were treated with Placebo in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects received either CZP 400 mg subcutaneously (sc) at Weeks 0, 2, and 4 followed by CZP 200 mg sc every two weeks (Q2W) if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
|
Open-label Cimzia (Cimzia in Feeder Study)
Subjects were treated with CZP in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects receive either CZP 400 mg sc at Weeks 0, 2, and 4 followed by CZP 200 mg sc Q2W if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
4
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
An Open-label Extension Study of Certolizumab Pegol in Chinese Patients With Rheumatoid Arthritis Who Enrolled in RA0044
Baseline characteristics by cohort
| Measure |
Open-label Cimzia (Placebo in Feeder Study)
n=95 Participants
Subjects were treated with Placebo in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects received either CZP 400 mg subcutaneously (sc) at Weeks 0, 2, and 4 followed by CZP 200 mg sc every two weeks (Q2W) if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
|
Open-label Cimzia (Cimzia in Feeder Study)
n=251 Participants
Subjects were treated with CZP in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects receive either CZP 400 mg sc at Weeks 0, 2, and 4 followed by CZP 200 mg sc Q2W if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
|
Total Title
n=346 Participants
|
|---|---|---|---|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
47.5 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
47.2 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
216 Participants
n=7 Participants
|
293 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
91 Participants
n=5 Participants
|
239 Participants
n=7 Participants
|
330 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to the end of observation period (32 weeks)Population: Safety Set
TEAEs are defined as Advere Events (AEs) starting on or after the date of first study medication administration in this Open-label Extension (OLE) study up to 70 days post-last dose.
Outcome measures
| Measure |
Open-label Cimzia (Placebo in Feeder Study)
n=95 Participants
Subjects were treated with Placebo in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects received either CZP 400 mg subcutaneously (sc) at Weeks 0, 2, and 4 followed by CZP 200 mg sc every two weeks (Q2W) if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
|
Open-label Cimzia (Cimzia in Feeder Study)
n=251 Participants
Subjects were treated with CZP in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects receive either CZP 400 mg sc at Weeks 0, 2, and 4 followed by CZP 200 mg sc Q2W if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
|
|---|---|---|
|
Percentage of Subjects That Withdrew Due to a Treatment-emergent Adverse Event (TEAE)
|
2.1 percentage of participants
|
1.6 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline to the end of observation period (32 weeks)Population: Safety Set
TEAEs are defined as Adverse Events (AEs) starting on or after the date of first study medication administration in this Open-label Extension (OLE) study up to 70 days post-last dose.
Outcome measures
| Measure |
Open-label Cimzia (Placebo in Feeder Study)
n=95 Participants
Subjects were treated with Placebo in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects received either CZP 400 mg subcutaneously (sc) at Weeks 0, 2, and 4 followed by CZP 200 mg sc every two weeks (Q2W) if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
|
Open-label Cimzia (Cimzia in Feeder Study)
n=251 Participants
Subjects were treated with CZP in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects receive either CZP 400 mg sc at Weeks 0, 2, and 4 followed by CZP 200 mg sc Q2W if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
|
|---|---|---|
|
Percentage of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
|
65.3 percentage of participants
|
65.3 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline to the end of observation period (32 weeks)Population: Safety Set
Treatment emergent SAEs are defined as SAEs starting on or after the date of first study medication administration in this OLE study up to 70 days post-last dose.
Outcome measures
| Measure |
Open-label Cimzia (Placebo in Feeder Study)
n=95 Participants
Subjects were treated with Placebo in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects received either CZP 400 mg subcutaneously (sc) at Weeks 0, 2, and 4 followed by CZP 200 mg sc every two weeks (Q2W) if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
|
Open-label Cimzia (Cimzia in Feeder Study)
n=251 Participants
Subjects were treated with CZP in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects receive either CZP 400 mg sc at Weeks 0, 2, and 4 followed by CZP 200 mg sc Q2W if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
|
|---|---|---|
|
Percentage of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE)
|
6.3 percentage of participants
|
2.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Safety Set with Non-Responder-Imputation (NRI).
The ACR20 represents improvement from Baseline of at least 20 %, calculated from assessments of tender joint count, swollen joint count, Patient's Assessment of Arthritis Pain (PtAAP) -visual analog scale (VAS), Patient's Global Assessment of Disease Activity (PtGADA) -VAS, Physician's Global Assessment of Disease Activity (PhGADA) -VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-reactive protein (CRP). Responder was relative to baseline of RA0044. Baseline value in RA0044 was defined as the last non-missing measurement collected prior to first study drug administration in RA0044.
Outcome measures
| Measure |
Open-label Cimzia (Placebo in Feeder Study)
n=95 Participants
Subjects were treated with Placebo in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects received either CZP 400 mg subcutaneously (sc) at Weeks 0, 2, and 4 followed by CZP 200 mg sc every two weeks (Q2W) if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
|
Open-label Cimzia (Cimzia in Feeder Study)
n=251 Participants
Subjects were treated with CZP in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects receive either CZP 400 mg sc at Weeks 0, 2, and 4 followed by CZP 200 mg sc Q2W if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
|
|---|---|---|
|
Percentage of Subjects Meeting the American College of Rheumatology 20 (ACR20) in Relation to Baseline
|
72.6 percentage of participants
|
82.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Safety Set with Non-Responder-Imputation (NRI).
The ACR50 represents improvement from Baseline of at least 50 %, calculated from assessments of tender joint count, swollen joint count, Patient's Assessment of Arthritis Pain (PtAAP) -visual analog scale (VAS), Patient's Global Assessment of Disease Activity (PtGADA) -VAS, Physician's Global Assessment of Disease Activity (PhGADA) -VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-reactive protein (CRP). Responder was relative to baseline of RA0044. Baseline value in RA0044 was defined as the last non-missing measurement collected prior to first study administration in RA0044.
Outcome measures
| Measure |
Open-label Cimzia (Placebo in Feeder Study)
n=95 Participants
Subjects were treated with Placebo in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects received either CZP 400 mg subcutaneously (sc) at Weeks 0, 2, and 4 followed by CZP 200 mg sc every two weeks (Q2W) if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
|
Open-label Cimzia (Cimzia in Feeder Study)
n=251 Participants
Subjects were treated with CZP in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects receive either CZP 400 mg sc at Weeks 0, 2, and 4 followed by CZP 200 mg sc Q2W if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
|
|---|---|---|
|
Percentage of Subjects Meeting the American College of Rheumatology 50 (ACR50) in Relation to Baseline
|
45.3 percentage of participants
|
56.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Safety Set with Non-Responder-Imputation (NRI).
The ACR70 represents improvement from Baseline of at least 70 %, calculated from assessments of tender joint count, swollen joint count, Patient's Assessment of Arthritis Pain (PtAAP) -visual analog scale (VAS), Patient's Global Assessment of Disease Activity (PtGADA) -VAS, Physician's Global Assessment of Disease Activity (PhGADA) -VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-reactive protein (CRP). Responder was relative to baseline of RA0044. Baseline value in RA0044 was defined as the last non-missing measurement collected prior to first study administration in RA0044.
Outcome measures
| Measure |
Open-label Cimzia (Placebo in Feeder Study)
n=95 Participants
Subjects were treated with Placebo in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects received either CZP 400 mg subcutaneously (sc) at Weeks 0, 2, and 4 followed by CZP 200 mg sc every two weeks (Q2W) if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
|
Open-label Cimzia (Cimzia in Feeder Study)
n=251 Participants
Subjects were treated with CZP in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects receive either CZP 400 mg sc at Weeks 0, 2, and 4 followed by CZP 200 mg sc Q2W if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
|
|---|---|---|
|
Percentage of Subjects Meeting the American College of Rheumatology 70 (ACR70) in Relation to Baseline
|
17.9 percentage of participants
|
31.5 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Safety Set with last observation carried forward (LOCF). Only subjects with available data are included in the analysis of this Outcome Measure.
Each subject will complete the HAQ-DI questionnaire at the visit and provides an assessment of the impact of the disease and its treatment on physical function. HAQ-DI scores range from 0 to 3. Lower scores indicate less disability. Negative values indicate improvement from Baseline. Baseline refers to RA0044 baseline.
Outcome measures
| Measure |
Open-label Cimzia (Placebo in Feeder Study)
n=95 Participants
Subjects were treated with Placebo in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects received either CZP 400 mg subcutaneously (sc) at Weeks 0, 2, and 4 followed by CZP 200 mg sc every two weeks (Q2W) if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
|
Open-label Cimzia (Cimzia in Feeder Study)
n=251 Participants
Subjects were treated with CZP in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects receive either CZP 400 mg sc at Weeks 0, 2, and 4 followed by CZP 200 mg sc Q2W if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
|
|---|---|---|
|
Change From Baseline Value in Health Assessment Questionnaire-Disability Index (HAQ-DI)
|
-0.526 units on a scale
Standard Deviation 0.621
|
-0.681 units on a scale
Standard Deviation 0.611
|
Adverse Events
Open-label Cimzia (Placebo in Feeder Study)
Serious events: 6 serious events
Other events: 21 other events
Deaths: 0 deaths
Open-label Cimzia (Cimzia in Feeder Study)
Serious events: 5 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open-label Cimzia (Placebo in Feeder Study)
n=95 participants at risk
Subjects were treated with Placebo in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects received either CZP 400 mg subcutaneously (sc) at Weeks 0, 2, and 4 followed by CZP 200 mg sc every two weeks (Q2W) if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
|
Open-label Cimzia (Cimzia in Feeder Study)
n=251 participants at risk
Subjects were treated with CZP in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects receive either CZP 400 mg sc at Weeks 0, 2, and 4 followed by CZP 200 mg sc Q2W if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
|
|---|---|---|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.1%
1/95 • Number of events 1 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
0.00%
0/251 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
1.1%
1/95 • Number of events 1 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
0.00%
0/251 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.1%
1/95 • Number of events 1 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
0.00%
0/251 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.1%
1/95 • Number of events 1 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
0.00%
0/251 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.1%
1/95 • Number of events 1 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
0.00%
0/251 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
|
Infections and infestations
Appendiceal abscess
|
0.00%
0/95 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
0.40%
1/251 • Number of events 1 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
|
Infections and infestations
Herpes zoster
|
1.1%
1/95 • Number of events 1 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
0.00%
0/251 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/95 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
0.40%
1/251 • Number of events 1 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.1%
1/95 • Number of events 1 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
0.00%
0/251 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/95 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
0.40%
1/251 • Number of events 1 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/95 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
0.40%
1/251 • Number of events 1 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/95 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
0.40%
1/251 • Number of events 1 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
|
Surgical and medical procedures
Hospitalisation
|
1.1%
1/95 • Number of events 1 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
0.00%
0/251 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
Other adverse events
| Measure |
Open-label Cimzia (Placebo in Feeder Study)
n=95 participants at risk
Subjects were treated with Placebo in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects received either CZP 400 mg subcutaneously (sc) at Weeks 0, 2, and 4 followed by CZP 200 mg sc every two weeks (Q2W) if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
|
Open-label Cimzia (Cimzia in Feeder Study)
n=251 participants at risk
Subjects were treated with CZP in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects receive either CZP 400 mg sc at Weeks 0, 2, and 4 followed by CZP 200 mg sc Q2W if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
5/95 • Number of events 7 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
5.6%
14/251 • Number of events 15 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.7%
13/95 • Number of events 14 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
15.5%
39/251 • Number of events 45 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
|
Investigations
Liver function test abnormal
|
5.3%
5/95 • Number of events 8 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
4.4%
11/251 • Number of events 11 • Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60