Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis (REALISTIC)

• ClinicalTrials.gov Identifier: NCT00717236
• Recruitment Status: Completed
• First Posted: July 17, 2008
• Results First Posted: May 6, 2011
• Last Update Posted: August 1, 2018
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Rheumatoid Arthritis
• Interventions: Drug: Certolizumab pegol (CZP); Other: Placebo
• Enrollment: 1648

Participant Flow

Recruitment Details	The study started in July 2008 with subjects from the United States, Canada, France, Germany, Italy, the Netherlands, and Spain. The primary completion date occurred in March 2010, with study completion in March 2011.
Pre-assignment Details	Of the 1648 subjects that were screened, 585 subjects had screen failures. Therefore, 1063 subjects were randomized in this study.

Arm/Group Title	Certolizumab Pegol (CZP)	Placebo
Arm/Group Description	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Period Title: Double-Blind Period
Started	851	212
Completed	771	184
Not Completed	80	28
Reason Not Completed
Adverse Event	33	6
Lack of Efficacy	6	6
Lost to Follow-up	3	5
Withdrawal by Subject	10	2
Loss of efficacy	3	0
Other: Death	1	0
Other: Pregnancy	1	0
Other: Protocol Violation	2	0
Other: Inclusion/Exclusion criteria	6	2
Other: Site withdrew	2	0
Other: Screening failure	1	0
Other: subject withdrew consent	1	1
Other: Abnormal chest X-ray	2	1
Other: History of adenoid grown	1	0
Other: History of cancer	1	0
Other: Sponsor request	1	0
Other: Inappropriate randomization	1	0
Other: Detection of Hepatitis C Virus	1	0
Other: Subject moved	1	1
Other: Stopped taking DMARD	1	0
Other: Prohibited medication taken	2	2
Other: Transportation problems	0	1
Other: Investigator Decision	0	1
Period Title: Open-Label Period
Started	771	184
Completed	646	163
Not Completed	125	21
Reason Not Completed
Adverse Event	29	4
Lack of Efficacy	30	8
Lost to Follow-up	28	4
Withdrawal by Subject	20	2
Loss of Efficacy	6	1
Other: Peripheral Neuropathy	0	1
Other: Lack of Compliance	1	1
Other: History of Basal Cell Carcinoma	1	0
Other: Moved	1	0
Other: Investigator Decision	1	0
Other: Loss of Staff (unblinded)	1	0
Other: Sponsor Request	3	0
Other: Cataract Surgery	1	0
Other: Administration of Golimumab	1	0
Other: Completion Accidently Performed	1	0
Other: Medical Monitor Recommendation	1	0

Baseline Characteristics

Arm/Group Title		Certolizumab Pegol (CZP)	Placebo	Total
Arm/Group Description		400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.	Total of all reporting groups
Overall Number of Baseline Participants		851	212	1063
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	851 participants	212 participants	1063 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	644 75.7%	164 77.4%	808 76.0%
	>=65 years	207 24.3%	48 22.6%	255 24.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	851 participants	212 participants	1063 participants
		55.4 (12.43)	53.9 (12.66)	55.1 (12.49)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	851 participants	212 participants	1063 participants
	Female	660 77.6%	169 79.7%	829 78.0%
	Male	191 22.4%	43 20.3%	234 22.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants	Number Analyzed	851 participants	212 participants	1063 participants
France		14	0	14
United States		575	141	716
Canada		65	17	82
Spain		26	8	34
Netherlands		4	0	4
Germany		154	44	198
Italy		13	2	15

Outcome Measures

1. Primary Outcome

Title	American College of Rheumatology 20% (ACR20) Response at Week 12
Description	ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All 1063 subjects (851 CZP, 212 Placebo) included in the Full Analysis Set (FAS) are included in this analysis

Arm/Group Title	Certolizumab Pegol (CZP)	Placebo
Arm/Group Description:	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	851	212
Measure Type: Number; Unit of Measure: percentage of subjects
	51.1	25.9

2. Secondary Outcome

Title	American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Concomitant Methotrexate (MTX) Use.
Description	ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Of the 1063 subjects in the Full Analysis Set (FAS), 732 were in the concomitant methotrexate use stratum (589 CZP, 143 Placebo) and are included in this analysis.

Arm/Group Title	Certolizumab Pegol (CZP)	Placebo
Arm/Group Description:	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	589	143
Measure Type: Number; Unit of Measure: percentage of subjects
	52.5	28.0

3. Secondary Outcome

Title	American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Concomitant Methotrexate (MTX) Use.
Description	ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Of the 1063 subjects in the Full Analysis Set (FAS), 331 were in the no concomitant methotrexate use stratum (262 CZP, 69 Placebo) and are included in this analysis.

Arm/Group Title	Certolizumab Pegol (CZP)	Placebo
Arm/Group Description:	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	262	69
Measure Type: Number; Unit of Measure: percentage of subjects
	48.1	21.7

4. Secondary Outcome

Title	American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Prior Anti-tumor Necrosis (Anti-TNF) Use
Description	ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Of the 1063 subjects in the Full Analysis Set (FAS), 400 were in the prior anti-tumor necrosis (anti-TNF) use stratum (320 CZP, 80 Placebo) and are included in this analysis.

Arm/Group Title	Certolizumab Pegol (CZP)	Placebo
Arm/Group Description:	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	320	80
Measure Type: Number; Unit of Measure: percentage of subjects
	47.2	27.5

5. Secondary Outcome

Title	American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Prior Anti-tumor Necrosis (Anti-TNF) Use
Description	ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Of the 1063 subjects in the Full Analysis Set (FAS), 663 were in the no prior anti-tumor necrosis (anti-TNF) use stratum (531 CZP, 132 Placebo) and are included in this analysis.

Arm/Group Title	Certolizumab Pegol (CZP)	Placebo
Arm/Group Description:	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	531	132
Measure Type: Number; Unit of Measure: percentage of subjects
	53.5	25.0

6. Secondary Outcome

Title	American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration < 2 Years
Description	ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Of the 1063 subjects in the Full Analysis Set (FAS), 256 were in the disease duration less than 2 years stratum (206 CZP, 50 Placebo) and are included in this analysis.

Arm/Group Title	Certolizumab Pegol (CZP)	Placebo
Arm/Group Description:	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	206	50
Measure Type: Number; Unit of Measure: percentage of subjects
	50.0	30.0

7. Secondary Outcome

Title	American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration ≥ 2 Years.
Description	ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Of the 1063 subjects in the Full Analysis Set (FAS), 807 were in the disease duration greater than or equal to 2 years stratum (645 CZP, 162 Placebo) and are included in this analysis.

Arm/Group Title	Certolizumab Pegol (CZP)	Placebo
Arm/Group Description:	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	645	162
Measure Type: Number; Unit of Measure: percentage of subjects
	51.5	24.7

8. Secondary Outcome

Title	American College of Rheumatology 50% (ACR50) Response at Week 12
Description	ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.

Arm/Group Title	Certolizumab Pegol (CZP)	Placebo
Arm/Group Description:	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	851	212
Measure Type: Number; Unit of Measure: percentage of subjects
	26.6	9.9

9. Secondary Outcome

Title	American College of Rheumatology 70% (ACR70) Response at Week 12.
Description	ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.

Arm/Group Title	Certolizumab Pegol (CZP)	Placebo
Arm/Group Description:	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	851	212
Measure Type: Number; Unit of Measure: percentage of subjects
	12.9	2.8

10. Secondary Outcome

Title	Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 12
Description	DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Of the 1063 subjects in the Full Analysis Set (FAS) 1037(834 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol (CZP)	Placebo
Arm/Group Description:	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	834	203
Mean (Standard Deviation); Unit of Measure: units on a scale
	-1.70 (1.269)	-0.84 (1.209)

11. Secondary Outcome

Title	Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12
Description	SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Of the 1063 subjects in the Full Analysis Set (FAS) 1024 (824 CZP, 200 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol (CZP)	Placebo
Arm/Group Description:	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	824	200
Mean (Standard Deviation); Unit of Measure: units on a scale
	-19.66 (14.493)	-10.78 (15.172)

12. Secondary Outcome

Title	Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12
Description	CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Of the 1063 subjects in the Full Analysis Set (FAS) 1024 (824 CZP, 200 Placebo) are included in this analysis.

Arm/Group Title	Certolizumab Pegol (CZP)	Placebo
Arm/Group Description:	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	824	200
Mean (Standard Deviation); Unit of Measure: units on a scale
	-18.96 (14.019)	-10.93 (14.494)

13. Secondary Outcome

Title	DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 12
Description	DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.

Arm/Group Title	Certolizumab Pegol (CZP)	Placebo
Arm/Group Description:	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	851	212
Measure Type: Number; Unit of Measure: percentage of subjects
	16.0	5.7

14. Secondary Outcome

Title	SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 12
Description	SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.

Arm/Group Title	Certolizumab Pegol (CZP)	Placebo
Arm/Group Description:	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	851	212
Measure Type: Number; Unit of Measure: percentage of subjects
	7.8	1.9

15. Secondary Outcome

Title	CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 12
Description	CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.

Arm/Group Title	Certolizumab Pegol (CZP)	Placebo
Arm/Group Description:	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	851	212
Measure Type: Number; Unit of Measure: percentage of subjects
	8.3	1.9

16. Secondary Outcome

Title	Change From Baseline in Tender Joint Count (TJC) at Week 12
Description	TJC is calculated based on tenderness response of 28 joints. TJC possible values range from 0 to 28. A lower TJC indicates less joint tenderness. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Of the 1063 subjects in the Full Analysis Set (FAS) 1043 (838 CZP, 205 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol (CZP)	Placebo
Arm/Group Description:	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	838	205
Mean (Standard Deviation); Unit of Measure: units on a scale
	-7.4 (7.13)	-4.5 (7.38)

17. Secondary Outcome

Title	Change From Baseline in Swollen Joint Count (SJC) at Week 12
Description	SJC is calculated based on swelling response of 28 joints. SJC possible values range from 0 to 28. A lower SJC indicates less joint swelling. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Of the 1063 subjects in the Full Analysis Set (FAS) 1043 (838 CZP, 205 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol (CZP)	Placebo
Arm/Group Description:	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	838	205
Mean (Standard Deviation); Unit of Measure: units on a scale
	-6.4 (5.57)	-3.6 (5.64)

18. Secondary Outcome

Title	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12
Description	HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Of the 1063 subjects in the Full Analysis Set (FAS) 1029 (826 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol (CZP)	Placebo
Arm/Group Description:	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	826	203
Mean (Standard Deviation); Unit of Measure: units on a scale
	-0.38 (0.524)	-0.19 (0.507)

19. Secondary Outcome

Title	Change From Baseline in C-reactive Protein (CRP) at Week 12
Description	Change from baseline in CRP (mg/L) is computed as the ratio of Week 12 value divided by baseline value. A ratio less then 1 indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Of the 1063 subjects in the Full Analysis Set (FAS) 1046 (841 CZP, 205 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol (CZP)	Placebo
Arm/Group Description:	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	841	205
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: mg/L
	0.55; (0.0% to 16.6%)	1.05; (0.1% to 17.6%)

20. Secondary Outcome

Title	Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 12
Description	Change from Baseline in PAAP-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Of the 1063 subjects in the Full Analysis Set (FAS) 1038 (835 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol (CZP)	Placebo
Arm/Group Description:	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	835	203
Mean (Standard Deviation); Unit of Measure: mm
	-22.1 (28.31)	-10.7 (27.32)

21. Secondary Outcome

Title	Change From Baseline in Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 12
Description	Change from Baseline in PtGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Of the 1063 subjects in the Full Analysis Set (FAS) 1038 (835 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol (CZP)	Placebo
Arm/Group Description:	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	835	203
Mean (Standard Deviation); Unit of Measure: mm
	-21.5 (27.78)	-10.1 (26.24)

22. Secondary Outcome

Title	Change From Baseline in Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 12
Description	Change from Baseline in PhGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Of the 1063 subjects in the Full Analysis Set (FAS) 1029 (827 CZP, 202 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol (CZP)	Placebo
Arm/Group Description:	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	827	202
Mean (Standard Deviation); Unit of Measure: mm
	-31.2 (23.58)	-19.0 (25.15)

23. Secondary Outcome

Title	Time to Sustained American College of Rheumatology 20% (ACR20) Response
Description	The time from randomization to sustained ACR20 response at 2 consecutive visits (at the latest on Week 12).
Time Frame	Baseline up to Week 12

Outcome Measure Data

Analysis Population Description

All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.

Arm/Group Title	Certolizumab Pegol (CZP)	Placebo
Arm/Group Description:	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	851	212
Measure Type: Number; Unit of Measure: percentage of subjects
	40.4	13.2

24. Secondary Outcome

Title	European League Against Rheumatism (EULAR) Response at Week 12
Description	EULAR response (good response, moderate response, or no response) is defined based on the present value and improvement from baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive protein)].
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.

Arm/Group Title	Certolizumab Pegol (CZP)	Placebo
Arm/Group Description:	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	851	212
Measure Type: Number; Unit of Measure: percentage of subjects
Good response	28.9	10.4
Moderate response	44.5	37.3
No response	26.6	52.4

25. Secondary Outcome

Title	American College of Rheumatology 20% (ACR20) Response at Week 28
Description	ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS). This analysis was carried out using imputation.
Time Frame	Baseline, Week 28

Outcome Measure Data

Analysis Population Description

Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis

Arm/Group Title	Open Label Certolizumab Pegol (CZP)
Arm/Group Description:	Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	954
Measure Type: Number; Unit of Measure: percentage of subjects
	58.5

26. Secondary Outcome

Title	American College of Rheumatology 50% (ACR50) Response at Week 28
Description	ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS). This analysis was carried out using imputation.
Time Frame	Baseline, Week 28

Outcome Measure Data

Analysis Population Description

Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis

Arm/Group Title	Open Label Certolizumab Pegol (CZP)
Arm/Group Description:	Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	954
Measure Type: Number; Unit of Measure: percentage of subjects
	35.0

27. Secondary Outcome

Title	American College of Rheumatology 70% (ACR70) Response at Week 28
Description	ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS). This analysis was carried out using imputation.
Time Frame	Baseline, Week 28

Outcome Measure Data

Analysis Population Description

Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis

Arm/Group Title	Open Label Certolizumab Pegol (CZP)
Arm/Group Description:	Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	954
Measure Type: Number; Unit of Measure: percentage of subjects
	17.4

28. Secondary Outcome

Title	Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 28
Description	DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. Change from Baseline is computed as the value at Week 28 minus Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
Time Frame	Baseline, Week 28

Outcome Measure Data

Analysis Population Description

Of the 954 subjects in the Open Label Set (OLS) 840 had observed values at Week 28 and Baseline and are included in this analysis.

Arm/Group Title	Open Label Certolizumab Pegol (CZP)
Arm/Group Description:	Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	840
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-1.94 (0.055)

29. Secondary Outcome

Title	Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 28
Description	SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from Baseline is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
Time Frame	Baseline, Week 28

Outcome Measure Data

Analysis Population Description

Of the 954 subjects in the Open Label Set (OLS) 828 had observed values at Week 28 and Baseline and are included in this analysis.

Arm/Group Title	Open Label Certolizumab Pegol (CZP)
Arm/Group Description:	Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	828
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-22.35 (0.546)

30. Secondary Outcome

Title	Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 28
Description	CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from Baseline is computed as value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
Time Frame	Baseline, Week 28

Outcome Measure Data

Analysis Population Description

Of the 954 subjects in the Open Label Set (OLS) 840 had observed values at Week 28 and Baseline and are included in this analysis.

Arm/Group Title	Open Label Certolizumab Pegol (CZP)
Arm/Group Description:	Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	840
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-21.66 (0.533)

31. Secondary Outcome

Title	DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 28
Description	DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. This analysis was carried out using imputation.
Time Frame	Week 28

Outcome Measure Data

Analysis Population Description

Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis

Arm/Group Title	Open Label Certolizumab Pegol (CZP)
Arm/Group Description:	Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	954
Measure Type: Number; Unit of Measure: percentage of subjects
	22.6

32. Secondary Outcome

Title	SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 28
Description	SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. This analysis was carried out using imputation.
Time Frame	Week 28

Outcome Measure Data

Analysis Population Description

Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis

Arm/Group Title	Open Label Certolizumab Pegol (CZP)
Arm/Group Description:	Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	954
Measure Type: Number; Unit of Measure: percentage of subjects
	11.4

33. Secondary Outcome

Title	CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 28
Description	CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. This analysis was carried out using imputation.
Time Frame	Week 28

Outcome Measure Data

Analysis Population Description

Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis

Arm/Group Title	Open Label Certolizumab Pegol (CZP)
Arm/Group Description:	Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	954
Measure Type: Number; Unit of Measure: percentage of subjects
	12.1

34. Secondary Outcome

Title	Change From Baseline in Tender Joint Count (TJC) at Week 28
Description	TJC is calculated based on tenderness response of 28 joints. TJC possible values range from 0 to 28. A lower TJC indicates less joint tenderness. Change from Baseline is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
Time Frame	Baseline, Week 28

Outcome Measure Data

Analysis Population Description

Of the 954 subjects in the Open Label Set (OLS) 861 had observed values at Week 28 and Baseline and are included in this analysis.

Arm/Group Title	Open Label Certolizumab Pegol (CZP)
Arm/Group Description:	Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	861
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-8.6 (0.26)

35. Secondary Outcome

Title	Change From Baseline in Swollen Joint Count (SJC) at Week 28
Description	SJC is calculated based on swelling response of 28 joints. SJC possible values range from 0 to 28. A lower SJC indicates less joint swelling. Change from baseline is computed as the value at Week 28 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
Time Frame	Baseline, Week 28

Outcome Measure Data

Analysis Population Description

Of the 954 subjects in the Open Label Set (OLS) 861 had observed values at Week 28 and Baseline and are included in this analysis.

Arm/Group Title	Open Label Certolizumab Pegol (CZP)
Arm/Group Description:	Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	861
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-7.2 (0.19)

36. Secondary Outcome

Title	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 28
Description	HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Change from baseline is computed as the value at Week 28 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
Time Frame	Baseline, Week 28

Outcome Measure Data

Analysis Population Description

Of the 954 subjects in the Open Label Set (OLS) 854 had observed values at Week 28 and Baseline and are included in this analysis

Arm/Group Title	Open Label Certolizumab Pegol (CZP)
Arm/Group Description:	Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	854
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-0.46 (0.023)

37. Secondary Outcome

Title	Change From Baseline in C-reactive Protein (CRP) at Week 28
Description	Change from Baseline in CRP (mg/L) is computed as the ratio of the value at Week 28 divided by Baseline value. A ratio less then 1 indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
Time Frame	Baseline, Week 28

Outcome Measure Data

Analysis Population Description

Of the 954 subjects in the Open Label Set (OLS) 851 had observed values at Week 28 and Baseline and are included in this analysis

Arm/Group Title	Open Label Certolizumab Pegol (CZP)
Arm/Group Description:	Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	851
Least Squares Mean (95% Confidence Interval); Unit of Measure: mg/L
	0.59; (0.55 to 0.63)

38. Secondary Outcome

Title	Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 28
Description	Change from Baseline in PAAP-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
Time Frame	Baseline, Week 28

Outcome Measure Data

Analysis Population Description

Of the 954 subjects in the Open Label Set (OLS) 856 had observed values at Week 28 and Baseline and are included in this analysis

Arm/Group Title	Open Label Certolizumab Pegol (CZP)
Arm/Group Description:	Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	856
Least Squares Mean (Standard Error); Unit of Measure: mm
	-23.1 (1.06)

39. Secondary Outcome

Title	Change From Baseline in Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 28
Description	Change from Baseline in PtGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
Time Frame	Baseline, Week 28

Outcome Measure Data

Analysis Population Description

Of the 954 subjects in the Open Label Set (OLS) 857 had observed values at Week 28 and Baseline and are included in this analysis

Arm/Group Title	Open Label Certolizumab Pegol (CZP)
Arm/Group Description:	Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	857
Least Squares Mean (Standard Error); Unit of Measure: mm
	-23.0 (1.04)

40. Secondary Outcome

Title	Change From Baseline in Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 28
Description	Change from Baseline in PhGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
Time Frame	Baseline, Week 28

Outcome Measure Data

Analysis Population Description

Of the 954 subjects in the Open Label Set (OLS) 848 had observed values at Week 28 and Baseline and are included in this analysis

Arm/Group Title	Open Label Certolizumab Pegol (CZP)
Arm/Group Description:	Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Overall Number of Participants Analyzed	848
Least Squares Mean (Standard Error); Unit of Measure: mm
	-35.6 (0.85)

Adverse Events

Time Frame	The first two columns refer to the 12-week double blind phase, and an additional 12-week follow up for those who withdrew during the double blind period. The third column displays AEs for the 56-week open label phase and the 12-week safety follow-up.
Adverse Event Reporting Description	Of the 1063 subjects in the Full Analysis Set (FAS), 1055 are included in the adverse event reporting based upon the Safety Set (SS) population. The Safety Set includes all subjects randomized who received at least 1 dosing.
Arm/Group Title	Certolizumab Pegol (CZP)		Placebo		Open Label Certolizumab Pegol (CZP)
Arm/Group Description	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. From Week 12, 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.		Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. From Week 12, 200 mg certolizumab pegol (CZP) given as 1 subcutaneous injection every other week for a minimum 16 additional weeks until CZP is commercially available.		Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
All-Cause Mortality
	Certolizumab Pegol (CZP)		Placebo		Open Label Certolizumab Pegol (CZP)
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--
Serious Adverse Events
	Certolizumab Pegol (CZP)		Placebo		Open Label Certolizumab Pegol (CZP)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	52/846 (6.15%)		12/209 (5.74%)		77/954 (8.07%)
Blood and lymphatic system disorders
Anaemia * 1	0/846 (0.00%)	0	1/209 (0.48%)	1	0/954 (0.00%)	0
Lymphadenopathy * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Cardiac disorders
Coronary artery disease * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Cardiac failure * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	1/954 (0.10%)	1
Acute myocardial infarction * 1	2/846 (0.24%)	2	0/209 (0.00%)	0	2/954 (0.21%)	2
Arteriospasm coronary * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Myocardial infarction * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	3/954 (0.31%)	3
Artial fibrillation * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	2/954 (0.21%)	3
Cardiac failure congestive * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	3/954 (0.31%)	3
Perocardial effusion * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Supraventricular tachycardia * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Angina Pectoris * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Ear and labyrinth disorders
Vertigo * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Ear pain * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Gastrointestinal disorders
Pancreatitis * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Abdominal pain * 1	2/846 (0.24%)	2	0/209 (0.00%)	0	0/954 (0.00%)	0
Nausea * 1	1/846 (0.12%)	1	1/209 (0.48%)	1	0/954 (0.00%)	0
Vomiting * 1	2/846 (0.24%)	2	0/209 (0.00%)	0	0/954 (0.00%)	0
Umbilical hernia * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Gastrooesophageal reflux disease * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Colitis ischaemic * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Diarrhoea * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	2/954 (0.21%)	2
Impaired gastric emptying * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Large intestine perforation * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Volvulus * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Stomatitis * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
General disorders
Chest pain * 1	3/846 (0.35%)	3	2/209 (0.96%)	2	1/954 (0.10%)	1
Non-cardiac chest pain * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Impaired healing * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Necrosis * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Hepatobiliary disorders
Cholecystitis * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Immune system disorders
Drug hypersensitivity * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Infections and infestations
Diverticulitis * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	2/954 (0.21%)	2
Bronchopulmonary aspergillosis * 1	2/846 (0.24%)	3	0/209 (0.00%)	0	0/954 (0.00%)	0
Cellulitis * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	5/954 (0.52%)	5
Bursitis infective * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Osteomyelitis * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Abscess limb * 1	2/846 (0.24%)	2	0/209 (0.00%)	0	0/954 (0.00%)	0
Bronchitis * 1	2/846 (0.24%)	2	0/209 (0.00%)	0	3/954 (0.31%)	4
Pneumonia * 1	4/846 (0.47%)	4	1/209 (0.48%)	1	8/954 (0.84%)	8
Pneumonia necrotising * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Urosepsis * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Staphylococcal infection * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Pharyngitis streptococcal * 1	0/846 (0.00%)	0	1/209 (0.48%)	1	1/954 (0.10%)	1
Upper respiratory tract infection * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Cystitis * 1	0/846 (0.00%)	0	1/209 (0.48%)	1	0/954 (0.00%)	0
Pyelonephritis acute * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Urinary tract infection * 1	3/846 (0.35%)	3	0/209 (0.00%)	0	3/954 (0.31%)	3
Gastroenteritis viral * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Pyelonephritis * 1	1/846 (0.12%)	1	1/209 (0.48%)	1	0/954 (0.00%)	0
Clostridial infection * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Gastroenteritis * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Ear lobe infection * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Postoperative wound infection * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Pneumonia streptococcal * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Disseminated tuberculosis * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Sinusitis * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	2/954 (0.21%)	2
Gastritis viral * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Injury, poisoning and procedural complications
Femoral neck fracture * 1	0/846 (0.00%)	0	1/209 (0.48%)	1	0/954 (0.00%)	0
Hip fracture * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Lower limb fracture * 1	0/846 (0.00%)	0	1/209 (0.48%)	1	0/954 (0.00%)	0
Tibia fracture * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Foreign body trauma * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Spinal compression fracture * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Concussion * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Subdural haematoma * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Device breakage * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Gastrointestinal disorder postoperative * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Ankle fracture * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Polytraumatism * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Skin laceration * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Upper limb fracture * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Investigations
Blood glucose increased * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	1/954 (0.10%)	1
Metabolism and nutrition disorders
Dehydration * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	3/954 (0.31%)	3
Diabetes mellitus * 1	0/846 (0.00%)	0	1/209 (0.48%)	1	0/954 (0.00%)	0
Hyponatraemia * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	3/954 (0.31%)	3
Spinal column stenosis * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Bursitis * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Intervertebral disc protrusion * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	2/954 (0.21%)	2
Rotator cuff syndrome * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Arthralgia * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Osteoarthritis * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	2/954 (0.21%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer * 1	0/846 (0.00%)	0	1/209 (0.48%)	1	1/954 (0.10%)	1
Carcinoid tumour * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Hepatic neoplasm * 1	0/846 (0.00%)	0	1/209 (0.48%)	1	0/954 (0.00%)	0
Adenocarcinoma pancreas * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Malignant melanoma * 1	1/846 (0.12%)	1	1/209 (0.48%)	1	1/954 (0.10%)	1
Sarcoma uterus * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Colon adenoma * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Breast cancer metastatic * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Ovarian granulosa-theca cell tumor * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Mycosis fungoides * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Small cell lung cancer metastatic * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	2/954 (0.21%)	2
Basal cell carcinoma * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Uterine leiomyoma * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Nervous system disorders
Syncope * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	2/954 (0.21%)	2
Brain stem infarction * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Grand mal convulsion * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Dizziness * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Pregnancy, puerperium and perinatal conditions
Pregnancy * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	1/954 (0.10%)	1
Psychiatric disorders
Suicide attempt * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Depression * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Renal and urinary disorders
Bladder prolapse * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Azotaemia * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Renal failure * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	2/954 (0.21%)	2
Renal failure acute * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Renal impairment * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Nephrolithiasis * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Reproductive system and breast disorders
Cervical dysplasia * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional * 1	0/846 (0.00%)	0	1/209 (0.48%)	1	1/954 (0.10%)	1
Asthma * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	1/954 (0.10%)	1
Chronic obstructive pulmonary disease * 1	2/846 (0.24%)	2	0/209 (0.00%)	0	0/954 (0.00%)	0
Pulmonary oedema * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Dyspnoea * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	1/954 (0.10%)	1
Pneumonitis * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Plural effusion * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Pulmonary embolism * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	2/954 (0.21%)	2
Skin and subcutaneous tissue disorders
Angioneurotic oedema * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Urticaria * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Drug eurption * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Skin ulcer * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Surgical and medical procedures
Gastric bypass * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Synoviorthesis * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Vascular disorders
Hypertensive crisis * 1	1/846 (0.12%)	1	0/209 (0.00%)	0	0/954 (0.00%)	0
Peripheral artery aneurysm * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Deep vein thrombosis * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	2/954 (0.21%)	2
Femoral arterial stenosis * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	1/954 (0.10%)	1
Hypertension * 1	0/846 (0.00%)	0	0/209 (0.00%)	0	2/954 (0.21%)	3
* 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 (CZP)		Placebo		Open Label Certolizumab Pegol (CZP)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	174/846 (20.57%)		42/209 (20.10%)		246/954 (25.79%)
Infections and infestations
Upper respiratory tract infection * 1	62/846 (7.33%)	68	11/209 (5.26%)	12	76/954 (7.97%)	83
Nasopharyngitis * 1	27/846 (3.19%)	31	4/209 (1.91%)	4	53/954 (5.56%)	58
Urinary Tract Infection * 1	24/846 (2.84%)	28	9/209 (4.31%)	10	64/954 (6.71%)	76
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis * 1	37/846 (4.37%)	46	16/209 (7.66%)	18	68/954 (7.13%)	83
Nervous system disorders
Headache * 1	46/846 (5.44%)	57	11/209 (5.26%)	13	35/954 (3.67%)	40
* 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.

UCB has > 60 but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.

Results Point of Contact

• Name/Title: UCB (Study Director)
• Organization: UCB Clinical Trial Call Center
• Phone: +1 887 822 9493

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

Pope J, Bingham CO 3rd, Fleischmann RM, Dougados M, Massarotti EM, Wollenhaupt J, Duncan B, Coteur G, Weinblatt ME. Impact of certolizumab pegol on patient-reported outcomes in rheumatoid arthritis and correlation with clinical measures of disease activity. Arthritis Res Ther. 2015 Nov 27;17:343. doi: 10.1186/s13075-015-0849-1.

Weinblatt ME, Fleischmann R, van Vollenhoven RF, Emery P, Huizinga TW, Cutolo M, van der Heijde D, Duncan B, Davies O, Luijtens K, Dougados M. Twenty-eight-week results from the REALISTIC phase IIIb randomized trial: efficacy, safety and predictability of response to certolizumab pegol in a diverse rheumatoid arthritis population. Arthritis Res Ther. 2015 Nov 15;17:325. doi: 10.1186/s13075-015-0841-9.

Weinblatt ME, Fleischmann R, Huizinga TW, Emery P, Pope J, Massarotti EM, van Vollenhoven RF, Wollenhaupt J, Bingham CO 3rd, Duncan B, Goel N, Davies OR, Dougados M. Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study. Rheumatology (Oxford). 2012 Dec;51(12):2204-14. doi: 10.1093/rheumatology/kes150. Epub 2012 Aug 25.

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00717236
• Other Study ID Numbers: C87094; 2008-005427-28 ( EudraCT Number )
• First Submitted: July 15, 2008
• First Posted: July 17, 2008
• Results First Submitted: March 10, 2011
• Results First Posted: May 6, 2011
• Last Update Posted: August 1, 2018