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

• 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: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Rheumatoid Arthritis
• Intervention: Biological: Certolizumab Pegol
• Enrollment: 567

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Certolizumab Pegol
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
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)

Outcome Measures

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
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)

Outcome Measure Data

Analysis Population Description

Safety Set

Arm/Group Title	Certolizumab Pegol
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
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)

Outcome Measure Data

Analysis Population Description

Safety Set

Arm/Group Title	Certolizumab Pegol
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
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)

Outcome Measure Data

Analysis Population Description

Safety Set

Arm/Group Title	Certolizumab Pegol
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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])
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)

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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)

Adverse Events

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
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	--/--
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)
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)

Limitations and Caveats

[Not Specified]

More Information

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)

Publications:

Paul S, Marotte H, Kavanaugh A, Goupille P, Kvien TK, de Longueville M, Mulleman D, Sandborn WJ, Vande Casteele N. Exposure-Response Relationship of Certolizumab Pegol and Achievement of Low Disease Activity and Remission in Patients With Rheumatoid Arthritis. Clin Transl Sci. 2020 Jul;13(4):743-751. doi: 10.1111/cts.12760. Epub 2020 Apr 1.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Curtis JR, Winthrop K, O'Brien C, Ndlovu MN, de Longueville M, Haraoui B. Use of a baseline risk score to identify the risk of serious infectious events in patients with rheumatoid arthritis during certolizumab pegol treatment. Arthritis Res Ther. 2017 Dec 15;19(1):276. doi: 10.1186/s13075-017-1466-y.

Smolen JS, van Vollenhoven R, Kavanaugh A, Strand V, Vencovsky J, Schiff M, Landewe R, Haraoui B, Arendt C, Mountian I, Carter D, van der Heijde D. Certolizumab pegol plus methotrexate 5-year results from the rheumatoid arthritis prevention of structural damage (RAPID) 2 randomized controlled trial and long-term extension in rheumatoid arthritis patients. Arthritis Res Ther. 2015 Sep 10;17(1):245. doi: 10.1186/s13075-015-0767-2.

• 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