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Trial record 1 of 1 for:    NCT00160641
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A Study of the Safety and Effectiveness of Liquid 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: NCT00160641
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : March 7, 2013
Last Update Posted : March 27, 2020
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 567
Recruitment Details Enrollment started in December 2005. 67 centers in 13 countries enrolled subjects. Participant Flow refers to the Safety Set (SS) consisting of all enrolled subjects who received at least 1 dose of study medication. Due to fraud findings at 1 site, data of the 15 subjects of site were not analyzed with data from all other sites and not part of SS.
Pre-assignment Details

This Open-label Study consists of two different populations:

of those subjects who failed to achieve predefined criteria in preceding study C87050 [NCT00160602] who entered C87051 on Week 16 of the preceding study and of those who completed the Week 24 assessment of the preceding study.

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: 1 ml of Liquid product 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 567
Completed 346
Not Completed 221
Reason Not Completed
Adverse Event             102
Withdrawal by Subject             87
Lost to Follow-up             8
Lack of Efficacy             12
Protocol Violation             3
Other             9
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: 1 ml of Liquid product 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 567
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 567 participants
<=18 years
0
   0.0%
Between 18 and 65 years
486
  85.7%
>=65 years
81
  14.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 567 participants
51.6  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 567 participants
Female
463
  81.7%
Male
104
  18.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 567 participants
United States 35
Serbia 46
Estonia 6
Slovakia 30
Ukraine 70
Lithuania 43
Israel 17
Russian Federation 105
Czech Republic 93
Poland 86
Croatia 10
Bulgaria 14
Latvia 12
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 567 participants
72.37  (14.86)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter (cm)
Number Analyzed 567 participants
165.23  (8.16)
1.Primary Outcome
Title Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 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 CZP was at Baseline of the preceding double-blind study NCT00160602 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 6.8 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: 1 ml of Liquid product 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 567
Measure Type: Number
Unit of Measure: percentage of participants
89.1
2.Primary Outcome
Title Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 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 NCT00160602 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 6.8 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: 1 ml of Liquid product 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 567
Measure Type: Number
Unit of Measure: percentage of participants
35.3
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 6.3 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: 1 ml of Liquid product 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 567
Measure Type: Number
Unit of Measure: percentage of participants
17.6
4.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 52
Hide Description The assessments are based on a 20 % or greater improvement from Baseline to Week 52 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 52 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 567 subjects in the Safety Set (SS), 493 are included in this analysis. Data not available for 74 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: 1 ml of Liquid product 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 493
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
81.7
(78.0 to 85.1)
5.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 100
Hide Description The assessments are based on a 20 % or greater improvement from Baseline to Week 100 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 100 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 567 subjects in the Safety Set (SS), 442 are included in this analysis. Data not available for 125 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: 1 ml of Liquid product 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 442
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
79.4
(75.3 to 83.1)
6.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 148
Hide Description The assessments are based on a 20 % or greater improvement from Baseline to Week 148 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 148 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 567 subjects in the Safety Set (SS), 410 are included in this analysis. Data not available for 157 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: 1 ml of Liquid product 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 410
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
80.2
(76.1 to 84.0)
7.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 196
Hide Description The assessments are based on a 20 % or greater improvement from Baseline to Week 196 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 196 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 567 subjects in the Safety Set (SS), 367 are included in this analysis. Data not available for 200 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: 1 ml of Liquid product 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 367
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
81.5
(77.1 to 85.3)
8.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 244
Hide Description The assessments are based on a 20 % or greater improvement from Baseline to Week 244 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 244 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 567 subjects in the Safety Set (SS), 72 are included in this analysis. Data not available for 495 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: 1 ml of Liquid product 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 72
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
88.9
(79.3 to 95.1)
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 6.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 567 subjects in the Safety Set (SS), 565 are included in this analysis. Data not available for 2 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: 1 ml of Liquid product 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 565
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
74.2
(70.3 to 77.7)
10.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 52
Hide Description The assessments are based on a 50 % or greater improvement from Baseline to Week 52 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 52 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 567 subjects in the Safety Set (SS), 493 are included in this analysis. Data not available for 74 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: 1 ml of Liquid product 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 493
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
48.9
(44.4 to 53.4)
11.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 100
Hide Description The assessments are based on a 50 % or greater improvement from Baseline to Week 100 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 100 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 567 subjects in the Safety Set (SS), 442 are included in this analysis. Data not available for 125 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: 1 ml of Liquid product 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 442
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
51.4
(46.6 to 56.1)
12.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 148
Hide Description The assessments are based on a 50 % or greater improvement from Baseline to Week 148 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 148 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 567 subjects in the Safety Set (SS), 410 are included in this analysis. Data not available for 157 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: 1 ml of Liquid product 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 410
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
51.7
(46.8 to 56.6)
13.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 196
Hide Description The assessments are based on a 50 % or greater improvement from Baseline to Week 196 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 196 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 567 subjects in the Safety Set (SS), 367 are included in this analysis. Data not available for 200 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: 1 ml of Liquid product 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 367
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
56.9
(51.7 to 62.1)
14.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 244
Hide Description The assessments are based on a 50 % or greater improvement from Baseline to Week 244 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 244 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 567 subjects in the Safety Set (SS), 72 are included in this analysis. Data not available for 495 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: 1 ml of Liquid product 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 72
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
62.5
(50.3 to 73.6)
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 6.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 567 subjects in the Safety Set (SS), 565 are included in this analysis. Data not available for 2 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: 1 ml of Liquid product 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 565
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
47.4
(43.3 to 51.6)
16.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 52
Hide Description The assessments are based on a 70 % or greater improvement from Baseline to Week 52 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 52 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 567 subjects in the Safety Set (SS), 493 are included in this analysis. Data not available for 74 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: 1 ml of Liquid product 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 493
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
26.2
(22.3 to 30.3)
17.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 100
Hide Description The assessments are based on a 70 % or greater improvement from Baseline to Week 100 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 100 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 567 subjects in the Safety Set (SS), 442 are included in this analysis. Data not available for 125 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: 1 ml of Liquid product 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 442
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
27.1
(23.1 to 31.6)
18.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 148
Hide Description The assessments are based on a 70 % or greater improvement from Baseline to Week 148 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 148 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 567 subjects in the Safety Set (SS), 410 are included in this analysis. Data not available for 157 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: 1 ml of Liquid product 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 410
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25.6
(21.5 to 30.1)
19.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 196
Hide Description The assessments are based on a 70 % or greater improvement from Baseline to Week 196 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 196 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 567 subjects in the Safety Set (SS), 367 are included in this analysis. Data not available for 200 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: 1 ml of Liquid product 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 367
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
29.4
(24.8 to 34.4)
20.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 244
Hide Description The assessments are based on a 70 % or greater improvement from Baseline to Week 244 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 244 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 567 subjects in the Safety Set (SS), 72 are included in this analysis. Data not available for 495 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: 1 ml of Liquid product 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 72
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
31.9
(21.4 to 44.0)
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 6.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 567 subjects in the Safety Set (SS), 565 are included in this analysis. Data not available for 2 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: 1 ml of Liquid product 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 565
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25.5
(21.9 to 29.3)
22.Secondary Outcome
Title Change From Baseline of the Preceding Double-Blind Study to Week 104 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 104 of the open-label study
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 567 subjects in the Safety Set (SS), 423 are included in this analysis. Data not available for 144 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: 1 ml of Liquid product 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 423
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.99  (4.99)
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 6.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 567 subjects in the Safety Set (SS), 560 are included in this analysis. Data not available for 7 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: 1 ml of Liquid product 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 560
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.567  (0.633)
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 6.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 567 subjects in the Safety Set (SS), 563 are included in this analysis. Data not available for 4 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: 1 ml of Liquid product 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 563
Mean (Standard Deviation)
Unit of Measure: hours
-2.31  (3.31)
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 6.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 567 subjects in the Safety Set (SS), 556 are included in this analysis. Data not available for 11 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: 1 ml of Liquid product 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 556
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.990  (1.408)
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 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 6.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 567 subjects in the Safety Set (SS), 556 are included in this analysis. Data not available for 11 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: 1 ml of Liquid product 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 556
Measure Type: Number
Unit of Measure: percentage of participants
36.0
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 6.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 567 subjects in the Safety Set (SS), 527 are included in this analysis. Data not available for 40 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: 1 ml of Liquid product 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 527
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.628  (8.950)
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 6.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 567 subjects in the Safety Set (SS), 527 are included in this analysis. Data not available for 40 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: 1 ml of Liquid product 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 527
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.325  (12.208)
Time Frame Adverse Events (AEs) were collected up to approximately 6.8 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: 1 ml of Liquid product 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   --/--    
Hide Serious Adverse Events
Certolizumab Pegol
Affected / at Risk (%) # Events
Total   200/567 (35.27%)    
Blood and lymphatic system disorders   
Anaemia * 1  1/567 (0.18%)  1
Haemolytic anaemia * 1  1/567 (0.18%)  1
Thrombocytopenia * 1  1/567 (0.18%)  1
Cardiac disorders   
Coronary artery disease * 1  1/567 (0.18%)  1
Cardiac failure * 1  1/567 (0.18%)  1
Cardiac failure chronic * 1  1/567 (0.18%)  1
Cardiac failure congestive * 1  1/567 (0.18%)  1
Cardiopulmonary failure * 1  1/567 (0.18%)  1
Acute myocardial infarction * 1  1/567 (0.18%)  1
Angina unstable * 1  1/567 (0.18%)  1
Myocardial infarction * 1  4/567 (0.71%)  4
Myocardial ischaemia * 1  2/567 (0.35%)  3
Bradycardia * 1  1/567 (0.18%)  1
Sick sinus syndrome * 1  1/567 (0.18%)  1
Ventricular arrhythmia * 1  1/567 (0.18%)  1
Congenital, familial and genetic disorders   
Pyloric stenosis * 1  1/567 (0.18%)  1
Ear and labyrinth disorders   
Vertigo * 1  2/567 (0.35%)  2
Eye disorders   
Cataract * 1  2/567 (0.35%)  2
Uveitis * 1  1/567 (0.18%)  1
Retinal detachment * 1  1/567 (0.18%)  1
Gastrointestinal disorders   
Gastric polyps * 1  1/567 (0.18%)  1
Small intestinal obstruction * 1  1/567 (0.18%)  1
Dyspepsia * 1  1/567 (0.18%)  1
Gastric ulcer * 1  2/567 (0.35%)  2
Gastroduodenitis * 1  1/567 (0.18%)  1
Abdominal pain * 1  1/567 (0.18%)  1
Abdominal pain upper * 1  3/567 (0.53%)  3
Food poisoning * 1  1/567 (0.18%)  1
Gastrointestinal perforation * 1  1/567 (0.18%)  1
Inguinal hernia * 1  1/567 (0.18%)  1
Gastrointestinal haemorrhage * 1  1/567 (0.18%)  1
Peritonitis * 1  1/567 (0.18%)  1
Periproctitis * 1  1/567 (0.18%)  1
General disorders   
Death and sudden death * 1  1/567 (0.18%)  1
Sudden cardiac death * 1  1/567 (0.18%)  1
Hernia * 1  1/567 (0.18%)  1
Cyst * 1  1/567 (0.18%)  1
Chest pain * 1  1/567 (0.18%)  1
Hepatobiliary disorders   
Cholecystitis * 1  1/567 (0.18%)  1
Cholecystitis acute * 1  2/567 (0.35%)  2
Cholecystitis chronic * 1  2/567 (0.35%)  2
Cholelithiasis * 1  5/567 (0.88%)  5
Cryptogenic cirrhosis * 1  1/567 (0.18%)  1
Hepatic cirrhosis * 1  1/567 (0.18%)  1
Hepatitis * 1  1/567 (0.18%)  1
Immune system disorders   
Serum sickness * 1  1/567 (0.18%)  1
Infections and infestations   
Anal abscess * 1  1/567 (0.18%)  1
Appendicitis * 1  1/567 (0.18%)  1
Diverticulitis * 1  1/567 (0.18%)  1
Gastroenteritis * 1  1/567 (0.18%)  1
Arthritis bacterial * 1  2/567 (0.35%)  2
Cellulitis * 1  5/567 (0.88%)  5
Gangrene * 1  1/567 (0.18%)  1
Arthritis infective * 1  1/567 (0.18%)  1
Bursitis infective * 1  3/567 (0.53%)  3
Osteomyelitis * 1  1/567 (0.18%)  1
Borrelia infection * 1  2/567 (0.35%)  2
Lyme disease * 1  1/567 (0.18%)  1
Colitis pseudomembranous * 1  1/567 (0.18%)  1
Tooth abscess * 1  1/567 (0.18%)  1
Otitis media acute * 1  2/567 (0.35%)  3
Salpingo-oophoritis * 1  1/567 (0.18%)  1
Tubo-ovarian abscess * 1  1/567 (0.18%)  1
Gallbladder empyema * 1  1/567 (0.18%)  1
Herpes zoster * 1  1/567 (0.18%)  1
Abscess limb * 1  1/567 (0.18%)  1
Postoperative wound infection * 1  1/567 (0.18%)  1
Pneumonia klebsiella * 1  1/567 (0.18%)  1
Bronchitis acute * 1  2/567 (0.35%)  2
Bronchopneumonia * 1  2/567 (0.35%)  3
Embolic pneumonia * 1  1/567 (0.18%)  1
Pneumonia * 1  9/567 (1.59%)  9
Pneumonia primary atypical * 1  1/567 (0.18%)  1
Papilloma viral infection * 1  1/567 (0.18%)  2
Carbuncle * 1  1/567 (0.18%)  1
Diabetic foot infection * 1  1/567 (0.18%)  1
Erysipelas * 1  3/567 (0.53%)  3
Pneumococcal sepsis * 1  1/567 (0.18%)  1
Pneumonia pneumococcal * 1  1/567 (0.18%)  1
Toxic shock syndrome streptococcal * 1  1/567 (0.18%)  1
Disseminated tuberculosis * 1  1/567 (0.18%)  1
Lymph node tuberculosis * 1  1/567 (0.18%)  1
Meningitis tuberculous * 1  1/567 (0.18%)  2
Pulmonary tuberculosis * 1  9/567 (1.59%)  9
Tuberculosis * 1  4/567 (0.71%)  4
Tuberculosis of central nervous system * 1  1/567 (0.18%)  1
Tuberculosis of intrathoracic lymph nodes * 1  1/567 (0.18%)  1
Laryngitis * 1  1/567 (0.18%)  1
Peritonsillar abscess * 1  2/567 (0.35%)  2
Upper respiratory tract infection * 1  1/567 (0.18%)  1
Cystitis * 1  1/567 (0.18%)  1
Pyelocystitis * 1  1/567 (0.18%)  1
Pyelonephritis * 1  1/567 (0.18%)  1
Pyelonephritis acute * 1  4/567 (0.71%)  4
Pyelonephritis chronic * 1  2/567 (0.35%)  2
Urinary tract infection * 1  2/567 (0.35%)  2
Injury, poisoning and procedural complications   
Joint dislocation * 1  2/567 (0.35%)  2
Stress fracture * 1  1/567 (0.18%)  1
Joint injury * 1  1/567 (0.18%)  1
Meniscus lesion * 1  1/567 (0.18%)  1
Ankle fracture * 1  1/567 (0.18%)  1
Femoral neck fracture * 1  1/567 (0.18%)  1
Femur fracture * 1  2/567 (0.35%)  2
Lower limb fracture * 1  1/567 (0.18%)  1
Tendon rupture * 1  1/567 (0.18%)  1
Road traffic accident * 1  1/567 (0.18%)  1
Wound * 1  1/567 (0.18%)  1
Postoperative hernia * 1  1/567 (0.18%)  1
Head injury * 1  1/567 (0.18%)  1
Neck injury * 1  1/567 (0.18%)  1
Contusion * 1  1/567 (0.18%)  1
Spinal compression fracture * 1  1/567 (0.18%)  1
Thermal burn * 1  1/567 (0.18%)  1
Sternal fracture * 1  1/567 (0.18%)  1
Forearm fracture * 1  1/567 (0.18%)  1
Ulna fracture * 1  1/567 (0.18%)  1
Upper limb fracture * 1  1/567 (0.18%)  1
Investigations   
Transaminases increased * 1  1/567 (0.18%)  1
Body temperature increased * 1  1/567 (0.18%)  1
Platelet count decreased * 1  1/567 (0.18%)  1
Chest X-ray abnormal * 1  1/567 (0.18%)  1
White blood cell count decreased * 1  1/567 (0.18%)  1
Metabolism and nutrition disorders   
Diabetes mellitus * 1  1/567 (0.18%)  1
Musculoskeletal and connective tissue disorders   
Arthritis * 1  1/567 (0.18%)  1
Arthritis reactive * 1  1/567 (0.18%)  1
Haemarthrosis * 1  1/567 (0.18%)  1
Osteonecrosis * 1  5/567 (0.88%)  7
Flat feet * 1  1/567 (0.18%)  1
Lower limb deformity * 1  1/567 (0.18%)  2
Toe deformity * 1  2/567 (0.35%)  2
Intervertebral disc protrusion * 1  1/567 (0.18%)  1
Arthralgia * 1  2/567 (0.35%)  3
Joint swelling * 1  1/567 (0.18%)  1
Back pain * 1  3/567 (0.53%)  3
Neck pain * 1  1/567 (0.18%)  1
Osteoarthritis * 1  10/567 (1.76%)  11
Rheumatoid arthritis * 1  19/567 (3.35%)  22
Fistula * 1  2/567 (0.35%)  2
Cervical spinal stenosis * 1  1/567 (0.18%)  1
Lumbar spinal stenosis * 1  2/567 (0.35%)  2
Tenosynovitis * 1  1/567 (0.18%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer * 1  2/567 (0.35%)  2
Breast cancer stage II * 1  1/567 (0.18%)  1
Squamous cell carcinoma of the cervix * 1  1/567 (0.18%)  1
Colon cancer * 1  2/567 (0.35%)  3
Colon cancer metastatic * 1  1/567 (0.18%)  1
Colon cancer stage II * 1  1/567 (0.18%)  1
Pituitary tumour benign * 1  1/567 (0.18%)  1
Gastric cancer * 1  1/567 (0.18%)  2
Pancreatic neoplasm * 1  1/567 (0.18%)  1
Gastrointestinal cancer metastatic * 1  1/567 (0.18%)  1
Hodgkin's disease stage III * 1  1/567 (0.18%)  1
Laryngeal cancer * 1  1/567 (0.18%)  1
Ganglioneuroma * 1  1/567 (0.18%)  1
Lung neoplasm * 1  1/567 (0.18%)  1
Lung neoplasm malignant * 1  3/567 (0.53%)  3
Malignant melanoma * 1  1/567 (0.18%)  1
Testis cancer * 1  1/567 (0.18%)  1
Uterine leiomyoma * 1  6/567 (1.06%)  6
Nervous system disorders   
Acoustic neuritis * 1  1/567 (0.18%)  1
Cerebral haemorrhage * 1  1/567 (0.18%)  1
Cerebrovascular accident * 1  2/567 (0.35%)  2
Vertebrobasilar insufficiency * 1  1/567 (0.18%)  1
Carpal tunnel syndrome * 1  1/567 (0.18%)  1
Radicular syndrome * 1  1/567 (0.18%)  1
Transient ischaemic attack * 1  7/567 (1.23%)  9
Vocal cord paralysis * 1  1/567 (0.18%)  2
Psychiatric disorders   
Mental disorder * 1  1/567 (0.18%)  1
Renal and urinary disorders   
Glomerulonephritis proliferative * 1  1/567 (0.18%)  1
Renal failure * 1  1/567 (0.18%)  1
Haematuria * 1  2/567 (0.35%)  2
Proteinuria * 1  1/567 (0.18%)  1
Calculus urinary * 1  1/567 (0.18%)  1
Renal colic * 1  2/567 (0.35%)  2
Reproductive system and breast disorders   
Menorrhagia * 1  1/567 (0.18%)  1
Metrorrhagia * 1  3/567 (0.53%)  4
Ovarian cyst * 1  4/567 (0.71%)  4
Colpocele * 1  1/567 (0.18%)  1
Uterine prolapse * 1  1/567 (0.18%)  1
Endometrial hyperplasia * 1  2/567 (0.35%)  2
Uterine haemorrhage * 1  1/567 (0.18%)  1
Uterine polyp * 1  1/567 (0.18%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnoea * 1  1/567 (0.18%)  1
Asthma * 1  1/567 (0.18%)  1
Chronic obstructive pulmonary disease * 1  1/567 (0.18%)  1
Rheumatoid lung * 1  2/567 (0.35%)  2
Hiccups * 1  1/567 (0.18%)  1
Interstitial lung disease * 1  1/567 (0.18%)  1
Pleurisy * 1  1/567 (0.18%)  1
Pleural effusion * 1  1/567 (0.18%)  1
Pulmonary embolism * 1  2/567 (0.35%)  2
Skin and subcutaneous tissue disorders   
Leukocytoclastic vasculitis * 1  1/567 (0.18%)  1
Surgical and medical procedures   
Peritoneal adhesions division * 1  1/567 (0.18%)  1
Hip arthroplasty * 1  2/567 (0.35%)  2
Knee arthroplasty * 1  1/567 (0.18%)  1
Vascular disorders   
Hypertensive crisis * 1  1/567 (0.18%)  1
Venous thrombosis * 1  1/567 (0.18%)  1
Deep vein thrombosis * 1  1/567 (0.18%)  1
Venous thrombosis limb * 1  2/567 (0.35%)  2
Varicose ulceration * 1  1/567 (0.18%)  1
Varicose vein * 1  1/567 (0.18%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Certolizumab Pegol
Affected / at Risk (%) # Events
Total   383/567 (67.55%)    
Infections and infestations   
Upper respiratory tract infection * 1  91/567 (16.05%)  150
Nasopharyngitis * 1  65/567 (11.46%)  99
Urinary tract infection * 1  60/567 (10.58%)  90
Bronchitis acute * 1  52/567 (9.17%)  69
Viral infection * 1  46/567 (8.11%)  61
Pharyngitis * 1  33/567 (5.82%)  48
Respiratory tract infection * 1  31/567 (5.47%)  48
Investigations   
Activated partial thromboplastin time prolonged * 1  65/567 (11.46%)  106
Alanine aminotransferase increased * 1  29/567 (5.11%)  42
Musculoskeletal and connective tissue disorders   
Rheumatoid arthritis * 1  76/567 (13.40%)  146
Back pain * 1  44/567 (7.76%)  56
Nervous system disorders   
Headache * 1  44/567 (7.76%)  61
Vascular disorders   
Hypertension * 1  77/567 (13.58%)  85
*
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
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
Phone: +1 877 822 9493 (UCB)
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00160641    
Other Study ID Numbers: C87051
2005-002629-30 ( EudraCT Number )
First Submitted: September 8, 2005
First Posted: September 12, 2005
Results First Submitted: January 31, 2013
Results First Posted: March 7, 2013
Last Update Posted: March 27, 2020