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A Study of the Safety and Effectiveness of Lyophilized Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00175877
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : March 8, 2013
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Intervention Biological: Certolizumab Pegol
Enrollment 857
Recruitment Details

Enrollment of subjects started in June 2005. 121 centers in 22 countries enrolled subjects.

Participant Flow refers to the Safety Set consisting of all enrolled subjects who received at least 1 dose of study medication.

Of the 857 enrolled subjects, 846 subjects are included in the Safety Set. There was 1 enrolled subject who was never dosed.

Pre-assignment Details

The study consists of 2 populations: of subjects who failed to achieve predefined criteria in preceding study NCT00152386 who entered C87028 on Week 16 of preceding study and of those who completed Week 52 of preceding study.

Due to findings of fraud at one site, data of the 10 subjects of the site were not analyzed with data from other sites.

Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Period Title: Overall Study
Started 846
Completed 497
Not Completed 349
Reason Not Completed
Adverse Event             136
Withdrawal by Subject             141
Lost to Follow-up             9
Lack of Efficacy             26
Protocol Violation             15
Other Reason             20
AE & Other             1
Withdrawal by subject & Other             1
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Baseline Participants 846
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Safety Set (SS). SS consists of all enrolled subjects who received at least 1 dose of study medication.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 846 participants
<=18 years
1
   0.1%
Between 18 and 65 years
736
  87.0%
>=65 years
109
  12.9%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 846 participants
51.5
(18 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 846 participants
Female
701
  82.9%
Male
145
  17.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 846 participants
Serbia 45
United States 56
Estonia 16
Slovakia 45
Finland 5
Ukraine 81
Lithuania 42
Russian Federation 102
Israel 24
Chile 11
France 2
Czech Republic 122
Hungary 57
Mexico 5
Canada 19
Argentina 122
Belgium 5
Croatia 3
Australia 12
Bulgaria 28
Latvia 26
New Zealand 18
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 846 participants
73.69  (16.17)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter (cm)
Number Analyzed 846 participants
164.30  (8.88)
1.Primary Outcome
Title Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years
Hide Description

An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.

First dose of Certolizumab Pegol (CZP) was at Baseline of the preceding double-blind study [NCT00152386] for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo.

Time Frame From first dose of CZP to the end of the open-label study (approximately 7 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 846
Measure Type: Number
Unit of Measure: percentage of participants
94.9
2.Primary Outcome
Title Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years
Hide Description

A SAE is any untoward medical occurrence that at any dose:

  • Results in death
  • Is life-threatening
  • Requires in patient hospitalisation or prolongation of existing hospitalisation
  • Results in persistent or significant disability/incapacity, or
  • Is a congenital anomaly or birth defect
  • Is as infection that requires treatment parenteral antibiotics
  • Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above

First dose of CZP was at Baseline of the preceding double-blind study [NCT00152386] for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo.

Time Frame From first dose of CZP to the end of the open-label study (approximately 7 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 846
Measure Type: Number
Unit of Measure: percentage of participants
41.6
3.Primary Outcome
Title Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study
Hide Description An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms.
Time Frame From Entry Visit (Week 0) to the end of the study (approximately 6.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 846
Measure Type: Number
Unit of Measure: percentage of participants
16.2
4.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 48
Hide Description The assessments are based on a 20 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame From Baseline of the preceding double-blind study to Week 48 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 846 subjects in the Safety Set (SS), 733 are included in this analysis. Data not available for 113 subjects.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 733
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
87.0
(84.4 to 89.4)
5.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 96
Hide Description The assessments are based on a 20 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame From Baseline of the preceding double-blind study to Week 96 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 846 subjects in the Safety Set (SS), 668 are included in this analysis. Data not available for 178 subjects.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 668
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
88.0
(85.3 to 90.4)
6.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 144
Hide Description The assessments are based on a 20 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame From Baseline of the preceding double-blind study to Week 144 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 846 subjects in the Safety Set (SS), 602 are included in this analysis. Data not available for 244 subjects.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 602
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
87.9
(85.0 to 90.4)
7.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 192
Hide Description The assessments are based on a 20 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame From Baseline of the preceding double-blind study to Week 192 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 846 subjects in the Safety Set (SS), 537 are included in this analysis. Data not available for 309 subjects.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 537
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
89.4
(86.5 to 91.9)
8.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 240
Hide Description The assessments are based on a 20 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame From Baseline of the preceding double-blind study to Week 240 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 846 subjects in the Safety Set (SS), 183 are included in this analysis. Data not available for 663 subjects.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 183
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
82.5
(76.2 to 87.7)
9.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Completion/Withdrawal
Hide Description The assessments are based on a 20 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 846 subjects in the Safety Set (SS), 841 are included in this analysis. Data not available for 5 subjects.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 841
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
81.3
(78.5 to 83.9)
10.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 48
Hide Description The assessments are based on a 50 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame From Baseline of the preceding double-blind study to Week 48 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 846 subjects in the Safety Set (SS), 733 are included in this analysis. Data not available for 113 subjects.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 733
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
63.0
(59.4 to 66.5)
11.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 96
Hide Description The assessments are based on a 50 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame From Baseline of the preceding double-blind study to Week 96 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 846 subjects in the Safety Set (SS), 668 are included in this analysis. Data not available for 178 subjects.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 668
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
66.0
(62.3 to 69.6)
12.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 144
Hide Description The assessments are based on a 50 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame From Baseline of the preceding double-blind study to Week 144 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 846 subjects in the Safety Set (SS), 602 are included in this analysis. Data not available for 244 subjects.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 602
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
65.4
(61.5 to 69.2)
13.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 192
Hide Description The assessments are based on a 50 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame From Baseline of the preceding double-blind study to Week 192 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 846 subjects in the Safety Set (SS), 537 are included in this analysis. Data not available for 309 subjects.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 537
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
64.8
(60.6 to 68.8)
14.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 240
Hide Description The assessments are based on a 50 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame From Baseline of the preceding double-blind study to Week 240 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 846 subjects in the Safety Set (SS), 183 are included in this analysis. Data not available for 663 subjects.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 183
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
58.5
(51.0 to 65.7)
15.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Completion/Withdrawal
Hide Description The assessments are based on a 50 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 846 subjects in the Safety Set (SS), 841 are included in this analysis. Data not available for 5 subjects.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 841
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
57.6
(54.1 to 60.9)
16.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 48
Hide Description The assessments are based on a 70 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame From Baseline of the preceding double-blind study to Week 48 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 846 subjects in the Safety Set (SS), 733 are included in this analysis. Data not available for 113 subjects.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 733
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
37.7
(34.1 to 41.3)
17.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 96
Hide Description The assessments are based on a 70 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame From Baseline of the preceding double-blind study to Week 96 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 846 subjects in the Safety Set (SS), 668 are included in this analysis. Data not available for 178 subjects.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 668
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
40.7
(37.0 to 44.6)
18.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 144
Hide Description The assessments are based on a 70 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame From Baseline of the preceding double-blind study to Week 144 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 846 subjects in the Safety Set (SS), 602 are included in this analysis. Data not available for 244 subjects.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 602
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
41.2
(37.2 to 45.2)
19.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 192
Hide Description The assessments are based on a 70 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame From Baseline of the preceding double-blind study to Week 192 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 846 subjects in the Safety Set (SS), 537 are included in this analysis. Data not available for 309 subjects.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 537
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
42.8
(38.6 to 47.1)
20.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 240
Hide Description The assessments are based on a 70 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame From Baseline of the preceding double-blind study to Week 240 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 846 subjects in the Safety Set (SS), 183 are included in this analysis. Data not available for 663 subjects.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 183
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
34.4
(27.6 to 41.8)
21.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Completion/Withdrawal
Hide Description The assessments are based on a 70 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time Frame From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 846 subjects in the Safety Set (SS), 841 are included in this analysis. Data not available for 5 subjects.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 841
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
38.2
(34.9 to 41.5)
22.Secondary Outcome
Title Change From Baseline of the Preceding Double-Blind Study to Week 96 in Modified Total Sharp Score (mTSS)
Hide Description The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively, as assessed by x-rays of the hands and feet. The score ranges from 0 to 448 with higher scores representing greater damage. A negative value in mTSS change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame From Baseline of the preceding double-blind study to Week 96 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 846 subjects in the Safety Set (SS), 661 are included in this analysis. Data not available for 185 subjects.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 661
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.95  (4.79)
23.Secondary Outcome
Title Change From Baseline of the Preceding Double-Blind Study to Completion/Withdrawal Visit in Health Assessment Questionnaire – Disability Index (HAQ-DI) Total Score
Hide Description The HAQ-DI assesses the degree of difficulty experienced in eight domains (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Gripping, Other Activities) of daily living activities using 20 questions. The HAQ-DI is calculated by summing the domain scores and dividing them by the number of domains. It ranges from 0 (no difficulty) to 3 (unable to do). Negative values indicate an improvement from Baseline to the Post-Baseline Visit with larger negative values showing a better improvement.
Time Frame From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 846 subjects in the Safety Set (SS), 824 are included in this analysis. Data not available for 22 subjects.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 824
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.674  (0.640)
24.Secondary Outcome
Title Change From Baseline to Completion/Withdrawal Visit in Duration of Morning Stiffness
Hide Description Morning stiffness is defined as the time in hours elapsed between the time of usual awakening (even if not in the morning) and the time the subject is as limber as he/she will be during a day involving typical activities. A negative value in duration of morning stiffness change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 846 subjects in the Safety Set (SS), 838 are included in this analysis. Data not available for 8 subjects.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 838
Mean (Standard Deviation)
Unit of Measure: hours
-2.147  (3.846)
25.Secondary Outcome
Title Change From Baseline to Completion/Withdrawal Visit in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR])
Hide Description DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline.
Time Frame From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 846 subjects in the Safety Set (SS), 834 are included in this analysis. Data not available for 12 subjects.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 834
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.222  (1.511)
26.Secondary Outcome
Title Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit
Hide Description Good EULAR response is defined as Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR]) improvement from Baseline of the preceding double-blind study > 1.2 and DAS28[ESR] value < 3.2.
Time Frame From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 846 subjects in the Safety Set (SS), 834 are included in this analysis. Data not available for 12 subjects.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 834
Measure Type: Number
Unit of Measure: percentage of participants
42.4
27.Secondary Outcome
Title Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Physical Component Summary (PCS) Score
Hide Description The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept PCS score are scored to yield values between 0 (worst) and 100 (best).
Time Frame From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 846 subjects in the Safety Set (SS), 777 are included in this analysis. Data not available for 69 subjects.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 777
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.813  (9.092)
28.Secondary Outcome
Title Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Mental Component Summary (MCS) Score
Hide Description The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept MCS score are scored to yield values between 0 (worst) and 100 (best).
Time Frame From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 846 subjects in the Safety Set (SS), 777 are included in this analysis. Data not available for 69 subjects.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

Overall Number of Participants Analyzed 777
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.612  (12.592)
Time Frame Adverse Events (AEs) were collected up to approximately 7 years, from first dose of Certolizumab Pegol (CZP) to the end of the open-label study.
Adverse Event Reporting Description AEs refer to the Safety Set. Safety Set includes all enrolled subjects who received at least 1 dose of study medication.
 
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.

All-Cause Mortality
Certolizumab Pegol
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Certolizumab Pegol
Affected / at Risk (%) # Events
Total   352/846 (41.61%)    
Blood and lymphatic system disorders   
Iron deficiency anaemia * 1  1/846 (0.12%)  1
Anaemia * 1  2/846 (0.24%)  2
Neutrophilia * 1  1/846 (0.12%)  1
Lymphadenitis * 1  1/846 (0.12%)  1
Lymphadenopathy * 1  1/846 (0.12%)  1
Lymphadenopathy mediastinal * 1  1/846 (0.12%)  2
Pancytopenia * 1  1/846 (0.12%)  1
Cardiac disorders   
Aortic valve disease * 1  1/846 (0.12%)  1
Atrioventricular block complete * 1  1/846 (0.12%)  1
Ischaemic cardiomyopathy * 1  1/846 (0.12%)  1
Coronary artery disease * 1  1/846 (0.12%)  1
Cardiac failure * 1  4/846 (0.47%)  4
Acute myocardial infarction * 1  1/846 (0.12%)  1
Angina pectoris * 1  4/846 (0.47%)  4
Angina unstable * 1  2/846 (0.24%)  2
Myocardial infarction * 1  5/846 (0.59%)  7
Myocardial ischaemia * 1  3/846 (0.35%)  3
Mitral valve incompetence * 1  1/846 (0.12%)  1
Myocarditis * 1  1/846 (0.12%)  1
Arrhythmia * 1  1/846 (0.12%)  1
Atrioventricular extrasystoles * 1  1/846 (0.12%)  1
Extrasystoles * 1  1/846 (0.12%)  1
Arrhythmia supraventricular * 1  1/846 (0.12%)  1
Atrial fibrillation * 1  6/846 (0.71%)  7
Supraventricular tachycardia * 1  1/846 (0.12%)  1
Cardiac arrest * 1  1/846 (0.12%)  1
Congenital, familial and genetic disorders   
Arnold-Chiari malformation * 1  1/846 (0.12%)  1
Ear and labyrinth disorders   
Vertigo * 1  1/846 (0.12%)  1
Vertigo positional * 1  1/846 (0.12%)  1
Eye disorders   
Cataract * 1  4/846 (0.47%)  5
Macular hole * 1  1/846 (0.12%)  2
Retinal detachment * 1  1/846 (0.12%)  1
Gastrointestinal disorders   
Abdominal hernia * 1  1/846 (0.12%)  1
Pancreatitis * 1  1/846 (0.12%)  1
Pancreatitis chronic * 1  1/846 (0.12%)  1
Tooth impacted * 1  1/846 (0.12%)  1
Hiatus hernia * 1  1/846 (0.12%)  1
Duodenal ulcer * 1  1/846 (0.12%)  1
Femoral hernia * 1  1/846 (0.12%)  1
Gastric ulcer * 1  1/846 (0.12%)  1
Gastritis * 1  1/846 (0.12%)  1
Abdominal pain * 1  4/846 (0.47%)  4
Gastrointestinal motility disorder * 1  1/846 (0.12%)  1
Ileus * 1  1/846 (0.12%)  2
Inguinal hernia * 1  4/846 (0.47%)  4
Nausea * 1  1/846 (0.12%)  1
Vomiting * 1  4/846 (0.47%)  4
Megacolon * 1  1/846 (0.12%)  1
Gastrointestinal haemorrhage * 1  1/846 (0.12%)  1
Melaena * 1  1/846 (0.12%)  1
Lip ulceration * 1  1/846 (0.12%)  1
General disorders   
Asthenia * 1  1/846 (0.12%)  1
Sudden death * 1  2/846 (0.24%)  2
Pyrexia * 1  5/846 (0.59%)  5
Chest pain * 1  2/846 (0.24%)  2
Non-cardiac chest pain * 1  1/846 (0.12%)  1
Hepatobiliary disorders   
Cholecystitis * 1  3/846 (0.35%)  3
Cholecystitis acute * 1  1/846 (0.12%)  1
Cholelithiasis * 1  10/846 (1.18%)  10
Hepatic cyst * 1  1/846 (0.12%)  1
Hepatitis alcoholic * 1  1/846 (0.12%)  1
Immune system disorders   
Sarcoidosis * 1  3/846 (0.35%)  3
Allergy to arthropod bite * 1  1/846 (0.12%)  1
Infections and infestations   
Anorectal infection * 1  1/846 (0.12%)  1
Appendicitis * 1  3/846 (0.35%)  3
Diverticulitis * 1  1/846 (0.12%)  1
Gastroenteritis * 1  3/846 (0.35%)  3
Peritoneal infection * 1  1/846 (0.12%)  1
Arthritis bacterial * 1  6/846 (0.71%)  6
Asymptomatic bacteriuria * 1  2/846 (0.24%)  2
Cellulitis * 1  11/846 (1.30%)  12
Folliculitis * 1  1/846 (0.12%)  1
Arthritis infective * 1  2/846 (0.24%)  2
Bursitis infective * 1  3/846 (0.35%)  3
Sialoadenitis * 1  1/846 (0.12%)  1
Tooth abscess * 1  1/846 (0.12%)  1
Ear infection * 1  2/846 (0.24%)  2
Otitis media acute * 1  1/846 (0.12%)  1
Infectious mononucleosis * 1  1/846 (0.12%)  1
Escherichia infection * 1  1/846 (0.12%)  1
Dacryocystitis infective * 1  1/846 (0.12%)  1
Salpingitis * 1  1/846 (0.12%)  1
Geotrichum infection * 1  1/846 (0.12%)  1
Cholecystitis infective * 1  1/846 (0.12%)  1
Herpes zoster * 1  5/846 (0.59%)  5
Herpes zoster disseminated * 1  1/846 (0.12%)  1
Histoplasmosis * 1  1/846 (0.12%)  1
Abscess soft tissue * 1  1/846 (0.12%)  1
Device related infection * 1  3/846 (0.35%)  3
Groin abscess * 1  1/846 (0.12%)  1
Localised infection * 1  1/846 (0.12%)  1
Postoperative wound infection * 1  3/846 (0.35%)  3
Wound infection * 1  1/846 (0.12%)  1
Bronchitis * 1  4/846 (0.47%)  4
Bronchitis acute * 1  5/846 (0.59%)  6
Bronchitis chronic * 1  1/846 (0.12%)  2
Bronchopneumonia * 1  2/846 (0.24%)  2
Lobar pneumonia * 1  2/846 (0.24%)  2
Lower respiratory tract infection * 1  1/846 (0.12%)  1
Obstructive chronic bronchitis with acute exacerbation * 1  1/846 (0.12%)  1
Pneumonia * 1  29/846 (3.43%)  31
Pyothorax * 1  2/846 (0.24%)  2
Nocardiosis * 1  1/846 (0.12%)  1
Condyloma acuminatum * 1  1/846 (0.12%)  1
Gastroenteritis salmonella * 1  2/846 (0.24%)  2
Sepsis * 1  4/846 (0.47%)  4
Urosepsis * 1  2/846 (0.24%)  2
Burn infection * 1  1/846 (0.12%)  1
Furuncle * 1  2/846 (0.24%)  2
Pyoderma * 1  1/846 (0.12%)  1
Soft tissue infection * 1  1/846 (0.12%)  1
Subcutaneous abscess * 1  5/846 (0.59%)  5
Pneumonia staphylococcal * 1  1/846 (0.12%)  1
Staphylococcal bacteraemia * 1  1/846 (0.12%)  1
Erysipelas * 1  6/846 (0.71%)  6
Meningitis streptococcal * 1  1/846 (0.12%)  1
Streptococcal bacteraemia * 1  1/846 (0.12%)  1
Disseminated tuberculosis * 1  4/846 (0.47%)  4
Pulmonary tuberculosis * 1  9/846 (1.06%)  9
Tuberculosis * 1  3/846 (0.35%)  3
Tuberculous pleurisy * 1  2/846 (0.24%)  2
Acute sinusitis * 1  2/846 (0.24%)  2
Acute tonsillitis * 1  1/846 (0.12%)  1
Chronic sinusitis * 1  1/846 (0.12%)  2
Chronic tonsillitis * 1  1/846 (0.12%)  1
Laryngitis * 1  1/846 (0.12%)  1
Laryngopharyngitis * 1  1/846 (0.12%)  1
Nasal vestibulitis * 1  1/846 (0.12%)  1
Pharyngitis * 1  3/846 (0.35%)  3
Rhinitis * 1  1/846 (0.12%)  1
Sinusitis * 1  3/846 (0.35%)  3
Tonsillitis * 1  4/846 (0.47%)  5
Pyelonephritis * 1  1/846 (0.12%)  1
Pyelonephritis acute * 1  4/846 (0.47%)  5
Urinary tract infection * 1  5/846 (0.59%)  5
Viral infection * 1  1/846 (0.12%)  1
Yersinia bacteraemia * 1  1/846 (0.12%)  1
Injury, poisoning and procedural complications   
Concussion * 1  4/846 (0.47%)  5
Traumatic brain injury * 1  1/846 (0.12%)  1
Haemothorax * 1  1/846 (0.12%)  1
Dislocation of joint prosthesis * 1  1/846 (0.12%)  1
Complication of device removal * 1  1/846 (0.12%)  1
Joint dislocation * 1  1/846 (0.12%)  1
Multiple fractures * 1  1/846 (0.12%)  1
Anastomotic ulcer * 1  1/846 (0.12%)  1
Joint injury * 1  2/846 (0.24%)  2
Limb traumatic amputation * 1  1/846 (0.12%)  1
Meniscus lesion * 1  1/846 (0.12%)  1
Femoral neck fracture * 1  3/846 (0.35%)  3
Femur fracture * 1  2/846 (0.24%)  2
Foot fracture * 1  1/846 (0.12%)  1
Hip fracture * 1  3/846 (0.35%)  4
Lower limb fracture * 1  6/846 (0.71%)  6
Tibia fracture * 1  3/846 (0.35%)  3
Tendon rupture * 1  1/846 (0.12%)  1
Excoriation * 1  1/846 (0.12%)  1
Polytraumatism * 1  1/846 (0.12%)  1
Wound secretion * 1  1/846 (0.12%)  1
Post procedural haemorrhage * 1  1/846 (0.12%)  1
Seroma * 1  1/846 (0.12%)  2
Intentional overdose * 1  1/846 (0.12%)  1
Overdose * 1  2/846 (0.24%)  2
Acetabulum fracture * 1  1/846 (0.12%)  1
Pelvic fracture * 1  2/846 (0.24%)  2
Drug toxicity * 1  1/846 (0.12%)  1
Neck injury * 1  1/846 (0.12%)  1
Vertebral injury * 1  1/846 (0.12%)  1
Contusion * 1  2/846 (0.24%)  2
Skin laceration * 1  2/846 (0.24%)  2
Skull fracture * 1  1/846 (0.12%)  1
Dislocation of vertebra * 1  2/846 (0.24%)  2
Thoracic vertebral fracture * 1  1/846 (0.12%)  1
Rib fracture * 1  1/846 (0.12%)  1
Forearm fracture * 1  3/846 (0.35%)  3
Hand fracture * 1  1/846 (0.12%)  1
Humerus fracture * 1  2/846 (0.24%)  2
Radius fracture * 1  1/846 (0.12%)  1
Upper limb fracture * 1  5/846 (0.59%)  5
Wrist fracture * 1  2/846 (0.24%)  2
Investigations   
Blood creatinine increased * 1  1/846 (0.12%)  1
Blood urea increased * 1  1/846 (0.12%)  1
Smear cervix abnormal * 1  1/846 (0.12%)  1
Chest X-ray abnormal * 1  1/846 (0.12%)  2
Blood creatine phosphokinase increased * 1  1/846 (0.12%)  1
Neutrophil count decreased * 1  1/846 (0.12%)  1
Metabolism and nutrition disorders   
Diabetes mellitus * 1  2/846 (0.24%)  2
Hypercholesterolaemia * 1  1/846 (0.12%)  1
Hypoglycaemia * 1  2/846 (0.24%)  2
Ketoacidosis * 1  1/846 (0.12%)  1
Musculoskeletal and connective tissue disorders   
Arthritis * 1  4/846 (0.47%)  5
Osteonecrosis * 1  7/846 (0.83%)  8
Finger deformity * 1  1/846 (0.12%)  1
Foot deformity * 1  1/846 (0.12%)  1
Knee deformity * 1  1/846 (0.12%)  1
Lower limb deformity * 1  1/846 (0.12%)  3
Toe deformity * 1  3/846 (0.35%)  3
Upper limb deformity * 1  1/846 (0.12%)  1
Wrist deformity * 1  1/846 (0.12%)  2
Intervertebral disc protusion * 1  2/846 (0.24%)  2
Joint destruction * 1  2/846 (0.24%)  2
Arthralgia * 1  4/846 (0.47%)  4
Back pain * 1  3/846 (0.35%)  3
Flank pain * 1  1/846 (0.12%)  1
Pain in extremity * 1  1/846 (0.12%)  1
Osteoarthritis * 1  8/846 (0.95%)  9
Osteoporotic fracture * 1  1/846 (0.12%)  1
Rheumatoid arthritis * 1  34/846 (4.02%)  38
Rheumatoid nodule * 1  1/846 (0.12%)  1
Scoliosis * 1  1/846 (0.12%)  1
Spondylitis * 1  1/846 (0.12%)  1
Synovial cyst * 1  1/846 (0.12%)  1
Synovitis * 1  1/846 (0.12%)  1
Shoulder deformity * 1  1/846 (0.12%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer * 1  3/846 (0.35%)  3
Colon cancer * 1  2/846 (0.24%)  2
Thyroid neoplasm * 1  1/846 (0.12%)  1
Endometrial cancer * 1  1/846 (0.12%)  1
Gastric cancer stage IV * 1  1/846 (0.12%)  1
Malignant peritoneal neoplasm * 1  1/846 (0.12%)  1
Lip and/ or oral cavity cancer * 1  1/846 (0.12%)  1
Castleman's disease * 1  1/846 (0.12%)  1
Metastases to central nervous system * 1  1/846 (0.12%)  1
Metastases to liver * 1  1/846 (0.12%)  1
Metastases to lung * 1  1/846 (0.12%)  1
Myeloproliferative disorder * 1  1/846 (0.12%)  1
Neoplasm malignant * 1  2/846 (0.24%)  2
Squamous cell carcinoma * 1  1/846 (0.12%)  1
Meningioma * 1  1/846 (0.12%)  1
Ovarian adenoma * 1  1/846 (0.12%)  1
Ovarian germ cell teratoma benign * 1  1/846 (0.12%)  1
Renal cell carcinoma stage II * 1  1/846 (0.12%)  1
Small cell lung cancer stage unspecified * 1  1/846 (0.12%)  1
Malignant melanoma * 1  2/846 (0.24%)  2
Basal cell carcinoma * 1  3/846 (0.35%)  4
Squamous cell carcinoma of skin * 1  1/846 (0.12%)  1
Benign urinary tract neoplasm * 1  1/846 (0.12%)  1
Uterine leiomyoma * 1  3/846 (0.35%)  3
Uterine cancer * 1  1/846 (0.12%)  1
Vaginal cancer stage 0 * 1  1/846 (0.12%)  1
Nervous system disorders   
Cerebral haemorrhage * 1  1/846 (0.12%)  1
Cerebrovascular accident * 1  4/846 (0.47%)  5
Ischaemic cerebral infarction * 1  1/846 (0.12%)  1
Cerebrovascular disorder * 1  1/846 (0.12%)  1
Vertebrobasilar insufficiency * 1  1/846 (0.12%)  1
Cervicobrachial syndrome * 1  1/846 (0.12%)  1
Diabetic neuropathy * 1  1/846 (0.12%)  1
Syncope * 1  3/846 (0.35%)  3
Syncope vasovagal * 1  1/846 (0.12%)  1
Grand mal convulsion * 1  1/846 (0.12%)  1
Headache * 1  2/846 (0.24%)  2
Dizziness * 1  1/846 (0.12%)  1
Hemiparesis * 1  1/846 (0.12%)  1
Radiculopathy * 1  1/846 (0.12%)  1
Transient ischaemic attack * 1  2/846 (0.24%)  2
Pregnancy, puerperium and perinatal conditions   
Pregnancy * 1  3/846 (0.35%)  3
Pregnancy on oral contraceptive * 1  1/846 (0.12%)  1
Psychiatric disorders   
Bipolar disorder * 1  1/846 (0.12%)  1
Confusional state * 1  1/846 (0.12%)  1
Depression * 1  3/846 (0.35%)  4
Conversion disorder * 1  1/846 (0.12%)  1
Suicide attempt * 1  1/846 (0.12%)  1
Renal and urinary disorders   
Stress incontinence * 1  1/846 (0.12%)  1
Bladder prolapse * 1  1/846 (0.12%)  1
Glomerulonephritis membranoproliferative * 1  1/846 (0.12%)  1
Renal failure * 1  1/846 (0.12%)  1
Renal cyst * 1  1/846 (0.12%)  1
Haematuria * 1  1/846 (0.12%)  1
Calculus ureteric * 1  1/846 (0.12%)  1
Renal colic * 1  4/846 (0.47%)  4
Reproductive system and breast disorders   
Cervical dysplasia * 1  1/846 (0.12%)  1
Cervical polyp * 1  2/846 (0.24%)  2
Metrorrhagia * 1  4/846 (0.47%)  4
Ovarian cyst * 1  2/846 (0.24%)  2
Ovarian haemorrhage * 1  1/846 (0.12%)  1
Uterine prolapse * 1  2/846 (0.24%)  2
Vaginal prolapse * 1  1/846 (0.12%)  1
Benign prostatic hyperplasia * 1  1/846 (0.12%)  1
Pelvic pain * 1  1/846 (0.12%)  1
Endometrial hyperplasia * 1  2/846 (0.24%)  2
Uterine haemorrhage * 1  1/846 (0.12%)  1
Uterine polyp * 1  2/846 (0.24%)  2
Bartholin's cyst * 1  1/846 (0.12%)  1
Vaginal haemorrhage * 1  1/846 (0.12%)  1
Respiratory, thoracic and mediastinal disorders   
Asthma * 1  1/846 (0.12%)  1
Chronic obstructive pulmonary disease * 1  4/846 (0.47%)  5
Alveolitis fibrosing * 1  1/846 (0.12%)  1
Nasal polyps * 1  1/846 (0.12%)  1
Emphysema * 1  1/846 (0.12%)  1
Interstitial lung disease * 1  1/846 (0.12%)  1
Lung infiltration * 1  2/846 (0.24%)  2
Pleurisy * 1  2/846 (0.24%)  2
Hydrothorax * 1  1/846 (0.12%)  1
Pleural effusion * 1  5/846 (0.59%)  6
Pneumothorax * 1  1/846 (0.12%)  1
Acute pulmonary oedema * 1  1/846 (0.12%)  1
Pulmonary embolism * 1  5/846 (0.59%)  5
Respiratory failure * 1  2/846 (0.24%)  2
Skin and subcutaneous tissue disorders   
Dermatitis allergic * 1  1/846 (0.12%)  1
Pityriasis rosea * 1  1/846 (0.12%)  1
Pruritus generalised * 1  1/846 (0.12%)  1
Purpura * 1  1/846 (0.12%)  1
Rash * 1  1/846 (0.12%)  1
Skin ulcer * 1  1/846 (0.12%)  1
Urticaria * 1  1/846 (0.12%)  1
Surgical and medical procedures   
Joint arthroplasty * 1  3/846 (0.35%)  3
Knee arthroplasty * 1  3/846 (0.35%)  3
Synovectomy * 1  1/846 (0.12%)  1
Brain operation * 1  1/846 (0.12%)  1
Therapy regimen changed * 1  1/846 (0.12%)  1
Hysterectomy * 1  1/846 (0.12%)  1
Vascular disorders   
Haematoma * 1  1/846 (0.12%)  1
Post thrombotic syndrome * 1  1/846 (0.12%)  1
Thrombosis * 1  1/846 (0.12%)  1
Venous thrombosis * 1  3/846 (0.35%)  3
Arteriosclerosis * 1  1/846 (0.12%)  1
Deep vein thrombosis * 1  6/846 (0.71%)  6
Trombophlebitis * 1  1/846 (0.12%)  1
Venous thrombosis limb * 1  3/846 (0.35%)  4
Essential hypertension * 1  1/846 (0.12%)  1
Hypertension * 1  2/846 (0.24%)  2
Orthostatic hypotension * 1  1/846 (0.12%)  1
Rheumatoid vasculitis * 1  2/846 (0.24%)  2
Vasculitis * 1  1/846 (0.12%)  1
Vena cava thrombosis * 1  1/846 (0.12%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Certolizumab Pegol
Affected / at Risk (%) # Events
Total   682/846 (80.61%)    
Blood and lymphatic system disorders   
Anaemia * 1  57/846 (6.74%)  77
Eye disorders   
Conjunctivitis * 1  55/846 (6.50%)  77
Gastrointestinal disorders   
Diarrhoea * 1  66/846 (7.80%)  90
Nausea * 1  53/846 (6.26%)  84
Dyspepsia * 1  57/846 (6.74%)  76
Gastritis * 1  48/846 (5.67%)  59
General disorders   
Pyrexia * 1  59/846 (6.97%)  86
Infections and infestations   
Urinary tract infection * 1  150/846 (17.73%)  280
Nasopharyngitis * 1  158/846 (18.68%)  270
Upper respiratory tract infection * 1  138/846 (16.31%)  267
Bronchitis acute * 1  99/846 (11.70%)  134
Pharyngitis * 1  86/846 (10.17%)  132
Herpes simplex * 1  71/846 (8.39%)  131
Influenza * 1  87/846 (10.28%)  115
Sinusitis * 1  72/846 (8.51%)  110
Bronchitis * 1  66/846 (7.80%)  89
Rhinitis * 1  56/846 (6.62%)  75
Respiratory tract infection * 1  45/846 (5.32%)  74
Investigations   
Hepatic enzyme increased * 1  45/846 (5.32%)  73
Alanine aminotransferase increased * 1  52/846 (6.15%)  72
Musculoskeletal and connective tissue disorders   
Rheumatoid arthritis * 1  133/846 (15.72%)  225
Back pain * 1  103/846 (12.17%)  150
Arthralgia * 1  71/846 (8.39%)  119
Nervous system disorders   
Headache * 1  92/846 (10.87%)  140
Psychiatric disorders   
Depression * 1  43/846 (5.08%)  54
Respiratory, thoracic and mediastinal disorders   
Cough * 1  58/846 (6.86%)  77
Skin and subcutaneous tissue disorders   
Rash * 1  63/846 (7.45%)  84
Vascular disorders   
Hypertension * 1  159/846 (18.79%)  242
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
Phone: +1 877 822 9493 (UCB)
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00175877     History of Changes
Other Study ID Numbers: C87028
2005-001350-24 ( EudraCT Number )
First Submitted: September 9, 2005
First Posted: September 15, 2005
Results First Submitted: February 4, 2013
Results First Posted: March 8, 2013
Last Update Posted: August 1, 2018