Dosing Flexibility Study in Patients With Rheumatoid Arthritis (DoseFlex)

• ClinicalTrials.gov Identifier: NCT00580840
• Recruitment Status: Completed
• First Posted: December 27, 2007
• Results First Posted: March 19, 2012
• Last Update Posted: August 2, 2018
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Rheumatoid Arthritis
• Interventions: Drug: Certolizumab pegol; Other: Placebo
• Enrollment: 333

Participant Flow

Recruitment Details	The study started in December 2007 with subjects from Canada, France, and United States. The primary completion date occurred in December 2010, with study completion in March 2011.
Pre-assignment Details

Arm/Group Title	Overall	CZP 400 mg and PLO + MTX	CZP 200 mg and PLO + MTX	PLO + MTX
Arm/Group Description	Overall for the Run-in period includes all 333 subjects that entered the study. Overall for the Double-blind period includes all 209 subjects that completed the Run-in period.	Certolizumab Pegol (CZP) 400 mg and Placebo (PLO) + Methotrexate (MTX)	Certolizumab Pegol (CZP) 200 mg and Placebo (PLO) + Methotrexate (MTX)	Placebo (PTO) + Methotrexate (MTX)
Period Title: Run-in
Started	333 [1]	0	0	0
Completed	209 [2]	0	0	0
Not Completed	124	0	0	0
Reason Not Completed
Adverse Event	17	0	0	0
Lack of Efficacy	93	0	0	0
Loss of Efficacy	1	0	0	0
Lost to Follow-up	4	0	0	0
Withdrawal by Subject	5	0	0	0
Other: Per Sponsor Request	2	0	0	0
Other: Did Not Meet Joint Count Criteria	1	0	0	0
Other: Exclusionary Lab Value	1	0	0	0
[1] 620 subjects were screened for the study with 333 being enrolled.; [2] Of the 209 randomized participants, 208 are in the Full Analysis Set (FAS).
Period Title: Double-Blind
Started	0	70	70	69
Completed	0	63	61	54
Not Completed	0	7	9	15
Reason Not Completed
Adverse Event	0	3	4	1
Loss of Efficacy	0	1	2	10
Lost to Follow-up	0	1	0	2
Withdrawal by Subject	0	1	2	2
Other: Discontinued Methotrexate	0	1	0	0
Other: Forbidden Medication	0	0	1	0

Baseline Characteristics

Arm/Group Title		Run-in Overall
Arm/Group Description		Overall includes all 333 subjects that entered the Run-in period of the study
Overall Number of Baseline Participants		333
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	333 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	264 79.3%
	>=65 years	69 20.7%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	333 participants
		54.2 (12.75)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	333 participants
	Female	253 76.0%
	Male	80 24.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants	Number Analyzed	333 participants
France		7
United States		306
Canada		20

Outcome Measures

1. Primary Outcome

Title	Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 34 in Patients Randomized at Week 18
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, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)
Time Frame	Baseline, Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	69	70	69
Measure Type: Number; Unit of Measure: percentage of subjects
	65.2	67.1	44.9

2. Secondary Outcome

Title	Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 16 in All Patients
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, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis

Arm/Group Title	Run-in Overall
Arm/Group Description:	Overall includes all 333 subjects that entered the Run-in period of the study
Overall Number of Participants Analyzed	333
Measure Type: Number; Unit of Measure: percentage of subjects
	61.3

3. Secondary Outcome

Title	Percentage of ACR50 (American College of Rheumatology 50% Improvement) Responders at Week 16 in All Patients
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, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis

Arm/Group Title	Run-in Overall
Arm/Group Description:	Overall includes all 333 subjects that entered the Run-in period of the study
Overall Number of Participants Analyzed	333
Measure Type: Number; Unit of Measure: percentage of subjects
	37.8

4. Secondary Outcome

Title	Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 16 in All Patients
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, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis

Arm/Group Title	Run-in Overall
Arm/Group Description:	Overall includes all 333 subjects that entered the Run-in period of the study
Overall Number of Participants Analyzed	333
Measure Type: Number; Unit of Measure: percentage of subjects
	16.2

5. Secondary Outcome

Title	Change From Baseline in DAS28 (Disease Activity Score-28 Items) at Week 16 in All Patients
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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. < 2.6 Remission, > = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

Of the 333 subjects in the Run-in period, 325 are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Run-in Overall
Arm/Group Description:	Overall includes all 333 subjects that entered the Run-in period of the study
Overall Number of Participants Analyzed	325
Mean (Standard Deviation); Unit of Measure: units on a scale
	-2.3 (1.3)

6. Secondary Outcome

Title	Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 16 in All Patients
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 Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. <= 3.3 Remission, > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

Of the 333 subjects in the Run-in period, 326 are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Run-in Overall
Arm/Group Description:	Overall includes all 333 subjects that entered the Run-in period of the study
Overall Number of Participants Analyzed	326
Mean (Standard Deviation); Unit of Measure: units on a scale
	-24.1 (13.5)

7. Secondary Outcome

Title	Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 16 in All Patients
Description	CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

Of the 333 subjects in the Run-in period, 328 are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Run-in Overall
Arm/Group Description:	Overall includes all 333 subjects that entered the Run-in period of the study
Overall Number of Participants Analyzed	328
Mean (Standard Deviation); Unit of Measure: units on a scale
	-23.3 (13.2)

8. Secondary Outcome

Title	DAS28 (Disease Activity Score-28 Items) Remission (DAS28 <2.6) at Week 16 in All Patients
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. Missing values were imputed using Non-Responder Imputation (NRI). < 2.6 (Remission), > = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis

Arm/Group Title	Run-in Overall
Arm/Group Description:	Overall includes all 333 subjects that entered the Run-in period of the study
Overall Number of Participants Analyzed	333
Measure Type: Number; Unit of Measure: percentage of subjects
	17.7

9. Secondary Outcome

Title	SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Week 16 in All Patients
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 Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI). <= 3.3 (Remission), > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis

Arm/Group Title	Run-in Overall
Arm/Group Description:	Overall includes all 333 subjects that entered the Run-in period of the study
Overall Number of Participants Analyzed	333
Measure Type: Number; Unit of Measure: percentage of subjects
	15.9

10. Secondary Outcome

Title	CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Week 16 in All Patients
Description	CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI). The range for the CDAI is 0 - 76 with a lower CDAI score indicating approvement in activity and a higher score indicating a decline activity.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis

Arm/Group Title	Run-in Overall
Arm/Group Description:	Overall includes all 333 subjects that entered the Run-in period of the study
Overall Number of Participants Analyzed	333
Measure Type: Number; Unit of Measure: percentage of subjects
	17.1

11. Secondary Outcome

Title	Ratio From Baseline in CRP (C-reactive Protein) Level at Week 16 in All Patients
Description	Ratio is defined as the CRP value at Week 16 divided by the CRP value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

Of the 333 subjects in the Run-in period, 330 are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Run-in Overall
Arm/Group Description:	Overall includes all 333 subjects that entered the Run-in period of the study
Overall Number of Participants Analyzed	330
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Ratio
	0.5; (122.6%)

12. Secondary Outcome

Title	Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) Score at Week 16 in All Patients
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). Thus, the mean also has a range from 0-3. Change from baseline is computed as the value at Week 16 minus the 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 16

Outcome Measure Data

Analysis Population Description

Of the 333 subjects in the Run-in period, 330 are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Run-in Overall
Arm/Group Description:	Overall includes all 333 subjects that entered the Run-in period of the study
Overall Number of Participants Analyzed	330
Mean (Standard Deviation); Unit of Measure: units on a scale
	-0.5 (0.6)

13. Secondary Outcome

Title	Percentage of ACR50 (American College of Rheumatology 50% Improvement) Responders at Week 34 in Patients Randomized at Week 18
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, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)
Time Frame	Baseline, Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	69	70	69
Measure Type: Number; Unit of Measure: percentage of subjects
	52.2	50.0	30.4

14. Secondary Outcome

Title	Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 34 in Patients Randomized at Week 18
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, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)
Time Frame	Baseline, Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	69	70	69
Measure Type: Number; Unit of Measure: percentage of subjects
	37.7	30.0	15.9

15. Secondary Outcome

Title	Change From Baseline in DAS28 (Disease Activity Score-28 Items) at Week 34 in Patients Randomized at Week 18
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. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward. < 2.6 Remission, > = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High
Time Frame	Baseline, Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 204 subjects (69 400 mg CZP, 68 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	69	68	67
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-3.04 (0.163)	-2.83 (0.164)	-1.65 (0.166)

16. Secondary Outcome

Title	Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 34 in Patients Randomized at Week 18
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 Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. <= 3.3 Remission, > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High
Time Frame	Baseline, Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	68	70	67
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-30.46 (1.554)	-28.15 (1.532)	-17.35 (1.571)

17. Secondary Outcome

Title	Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 34 in Patients Randomized at Week 18
Description	CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. Range for CDAI is 0-76 with a lower CDAI score reflects approvement in activity and a higher score reflects a decline.
Time Frame	Baseline, Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	69	70	67
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-29.06 (1.509)	-27.14 (1.498)	-17.03 (1.536)

18. Secondary Outcome

Title	DAS28 (Disease Activity Score-28 Items) Remission (DAS28 <2.6) at Week 34 in Patients Randomized at Week 18
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. Missing values were imputed using Non-Responder Imputation (NRI). < 2.6 (Remission), > = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High
Time Frame	Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	69	70	69
Measure Type: Number; Unit of Measure: percentage of subjects
	29.0	18.6	5.8

19. Secondary Outcome

Title	SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Week 34 in Patients Randomized at Week 18
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 Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI). <= 3.3 (Remission), > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High
Time Frame	Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	69	70	69
Measure Type: Number; Unit of Measure: percentage of subjects
	29.0	17.1	13.0

20. Secondary Outcome

Title	CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Week 34 in Patients Randomized at Week 18
Description	CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI). The range for the CDAI is 0 - 76 with a lower CDAI score indicating approvement in activity and a higher score indicating a decline activity.
Time Frame	Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	69	70	69
Measure Type: Number; Unit of Measure: percentage of subjects
	27.5	21.4	15.9

21. Secondary Outcome

Title	Ratio From Baseline in CRP (C-reactive Protein) Level at Week 34 in Patients Randomized at Week 18
Description	Ratio is defined as the CRP value at Week 34 divided by the CRP value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method with an ANCOVA model on observed log transformed data with factors treatment and log transformed Baseline CRP level. The number presented is the geometric least squares mean with it's 95% confidence interval.
Time Frame	Baseline, Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	69	70	68
Least Squares Mean (95% Confidence Interval); Unit of Measure: Ratio
	0.44; (0.36 to 0.53)	0.48; (0.40 to 0.58)	0.82; (0.68 to 0.99)

22. Secondary Outcome

Title	Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) Score at Week 34 in Patients Randomized at Week 18
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). Thus, the mean also has a range from 0-3. Change from baseline is computed as the value at Week 34 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame	Baseline, Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	69	70	68
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-0.64 (0.060)	-0.72 (0.060)	-0.38 (0.061)

23. Secondary Outcome

Title	Change From Baseline in Fatigue Assessment Scale (FAS) at Week 34 in Patients Randomized at Week 18
Description	Change from Baseline in Fatigue Assessment scale (0 to 10, 0 is "No Fatigue" and 10 is "Fatigue as bad as you can imagine") is computed as the value at Week 34 minus the Baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame	Baseline, Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	68	70	67
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-2.39 (0.261)	-3.03 (0.258)	-1.33 (0.264)

24. Secondary Outcome

Title	Change From Baseline in Physical Functioning (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18
Description	There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame	Baseline, Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	69	70	68
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	8.39 (1.080)	9.07 (1.076)	4.09 (1.086)

25. Secondary Outcome

Title	Change From Baseline in Role Physical (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18
Description	There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame	Baseline, Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	69	69	68
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	9.80 (1.095)	11.06 (1.097)	7.14 (1.099)

26. Secondary Outcome

Title	Change From Baseline in Bodily Pain (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18
Description	There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame	Baseline, Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	69	69	68
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	12.95 (1.042)	11.28 (1.044)	6.12 (1.047)

27. Secondary Outcome

Title	Change From Baseline in General Health (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18
Description	There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame	Baseline, Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	68	69	68
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	5.46 (0.959)	5.51 (0.956)	3.16 (0.961)

28. Secondary Outcome

Title	Change From Baseline in Vitality (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18
Description	There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame	Baseline, Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	68	69	68
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	9.88 (1.127)	11.53 (1.123)	5.47 (1.129)

29. Secondary Outcome

Title	Change From Baseline in Social Functioning (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18
Description	There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame	Baseline, Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	69	70	68
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	8.87 (1.179)	10.03 (1.170)	6.42 (1.187)

30. Secondary Outcome

Title	Change From Baseline in Role Emotional (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18
Description	There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame	Baseline, Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 204 subjects (67 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	67	69	68
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	6.86 (1.322)	8.86 (1.313)	5.86 (1.306)

31. Secondary Outcome

Title	Change From Baseline in Mental Health (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18
Description	There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame	Baseline, Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	68	69	68
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	5.38 (1.050)	7.44 (1.042)	4.13 (1.049)

32. Secondary Outcome

Title	Change From Baseline in PCS (Short Form 36-item Health Survey Physical Component Summary) at Week 34 in Patients Randomized at Week 18
Description	PCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from 1 to 81, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame	Baseline, Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 202 subjects (66 400 mg CZP, 68 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	66	68	68
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	10.54 (0.939)	9.65 (0.928)	5.09 (0.926)

33. Secondary Outcome

Title	Change From Baseline in MCS (Short Form 36-item Health Survey Mental Component Summary) at Week 34 in Patients Randomized at Week 18
Description	MCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from -9 to 82, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame	Baseline, Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 202 subjects (66 400 mg CZP, 68 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	66	68	68
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	5.51 (1.162)	8.59 (1.147)	4.90 (1.143)

34. Secondary Outcome

Title	Change From Baseline in PAAP (Patient's Assessment of Arthritis Pain) at Week 34 in Patients Randomized at Week 18
Description	Change from Baseline in Patient's Assessment of Arthritis Pain-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 34 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame	Baseline, Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	69	70	68
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-36.41 (2.894)	-34.33 (2.869)	-17.47 (2.911)

35. Secondary Outcome

Title	Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Week 34 in Patients Randomized at Week 18
Description	Change from Baseline in Patient's Global Assessment of Disease Activity-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 34 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame	Baseline, Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	69	70	68
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-35.58 (2.966)	-33.07 (2.946)	-16.37 (2.987)

36. Secondary Outcome

Title	Median Time to Loss of ACR20 (American College of Rheumatology 20% Improvement) Response After Week 18 in Patients Randomized at Week 18.
Description	ACR20 loss are subjects with <20% improvement from Baseline for tender joint count, swollen joint count, and at least 3/5 core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein, 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale at 2 consecutive visits. Subjects losing response for 2 consecutive visits are considered as having the event on the day of the visit where response was first lost.
Time Frame	Week 18 up to Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis.

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	69	70	69
Median (Inter-Quartile Range); Unit of Measure: days
	NA [1]; (100.0 to NA)	NA [1]; (NA to NA)	98.0 [1]; (17.0 to NA)

[1]

Because the analysis was run on the Full Analysis Set (FAS) the survival curves drop dramatically initially causing values to be non-computable.

37. Other Pre-specified Outcome

Title	Ratio From Baseline in ESR (Erythrocyte Sedimentation Rate) Level at Week 16 in All Patients
Description	Ratio is defined as the ESR value at Week 16 divided by the ESR value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

Of the 333 subjects in the Run-in period, 328 are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Run-in Overall
Arm/Group Description:	Overall includes all 333 subjects that entered the Run-in period of the study
Overall Number of Participants Analyzed	328
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Ratio
	0.6; (76.7%)

38. Other Pre-specified Outcome

Title	Ratio From Baseline in ESR (Erythrocyte Sedimentation Rate) Level at Week 34 in Patients Randomized at Week 18
Description	Ratio is defined as the ESR value at Week 34 divided by the ESR value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method with an ANCOVA model on observed log transformed data with factors treatment and log transformed Baseline CRP level. The number presented is the geometric least squares mean with it's 95% confidence interval.
Time Frame	Baseline, Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (69 400 mg CZP, 68 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	69	68	68
Least Squares Mean (95% Confidence Interval); Unit of Measure: Ratio
	0.56; (0.48 to 0.65)	0.62; (0.53 to 0.72)	0.84; (0.71 to 0.98)

39. Other Pre-specified Outcome

Title	Change From Baseline in PhGADA (Physician's Global Assessment of Disease Activity) at Week 34 in Patients Randomized at Week 18
Description	Change from Baseline in Physician's Global Assessment of Disease Activity-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 34 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame	Baseline, Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	69	70	67
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-44.62 (2.428)	-40.24 (2.427)	-25.97 (2.476)

40. Other Pre-specified Outcome

Title	Change From Baseline in TJC (Tender Joint Count) at Week 34 in Patients Randomized at Week 18
Description	Change from Baseline in Tender Joint Count is computed as the value at Week 34 minus the Baseline value (28 joints were assessed at each visit). A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame	Baseline, Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	69	70	68
Least Squares Mean (Standard Error); Unit of Measure: Joints
	-11.81 (0.702)	-11.33 (0.692)	-7.16 (0.707)

41. Other Pre-specified Outcome

Title	Change From Baseline in SJC (Swollen Joint Count) at Week 34 in Patients Randomized at Week 18
Description	Change from Baseline in Swollen Joint Count is computed as the value at Week 34 minus the Baseline value (28 joints were assessed at each visit). A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Time Frame	Baseline, Week 34

Outcome Measure Data

Analysis Population Description

Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	Certolizumab Pegol 400 mg and Placebo + Methotrexate	Certolizumab Pegol 200 mg and Placebo + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate	200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate	Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
Overall Number of Participants Analyzed	69	70	68
Least Squares Mean (Standard Error); Unit of Measure: Joints
	-9.29 (0.542)	-8.37 (0.540)	-5.41 (0.547)

Adverse Events

Time Frame	The first column represents Adverse Event (AE) reporting for the 16-Week run-in period. The last three columns represents AE reporting for the 18-Week double-blind period.
Adverse Event Reporting Description	Of the 209 randomized participants, 208 are in the Full Analysis Set (FAS), as 1 subject was randomized but did not receive treatment during the Double-Blind (DB) period.
Arm/Group Title	Run-in Overall		Certolizumab Pegol 400 mg and Placebo + Methotrexate		Certolizumab Pegol 200 mg and Placebo + Methotrexate		Placebo + Methotrexate
Arm/Group Description	Overall includes all 333 subjects that entered the Run-in period of the study		400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate		200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate		Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
All-Cause Mortality
	Run-in Overall		Certolizumab Pegol 400 mg and Placebo + Methotrexate		Certolizumab Pegol 200 mg and Placebo + Methotrexate		Placebo + Methotrexate
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--		--/--
Serious Adverse Events
	Run-in Overall		Certolizumab Pegol 400 mg and Placebo + Methotrexate		Certolizumab Pegol 200 mg and Placebo + Methotrexate		Placebo + Methotrexate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/333 (5.41%)		2/69 (2.90%)		5/70 (7.14%)		0/69 (0.00%)
Blood and lymphatic system disorders
Pancytopenia * 1	1/333 (0.30%)	1	0/69 (0.00%)	0	0/70 (0.00%)	0	0/69 (0.00%)	0
Thrombocytopenia * 1	1/333 (0.30%)	1	0/69 (0.00%)	0	0/70 (0.00%)	0	0/69 (0.00%)	0
Cardiac disorders
Coronary artery disease * 1	1/333 (0.30%)	1	0/69 (0.00%)	0	0/70 (0.00%)	0	0/69 (0.00%)	0
Angina pectoris * 1	1/333 (0.30%)	1	0/69 (0.00%)	0	0/70 (0.00%)	0	0/69 (0.00%)	0
Ventricular tachycardia * 1	1/333 (0.30%)	1	0/69 (0.00%)	0	0/70 (0.00%)	0	0/69 (0.00%)	0
Coronary artery occlusion * 1	0/333 (0.00%)	0	0/69 (0.00%)	0	1/70 (1.43%)	1	0/69 (0.00%)	0
Pericardial effusion * 1	0/333 (0.00%)	0	0/69 (0.00%)	0	1/70 (1.43%)	1	0/69 (0.00%)	0
Gastrointestinal disorders
Abdominal pain * 1	1/333 (0.30%)	1	0/69 (0.00%)	0	0/70 (0.00%)	0	0/69 (0.00%)	0
Colitis * 1	1/333 (0.30%)	1	0/69 (0.00%)	0	0/70 (0.00%)	0	0/69 (0.00%)	0
Gastrointestinal haemorrhage * 1	1/333 (0.30%)	1	0/69 (0.00%)	0	0/70 (0.00%)	0	0/69 (0.00%)	0
General disorders
Chest pain * 1	1/333 (0.30%)	1	0/69 (0.00%)	0	0/70 (0.00%)	0	0/69 (0.00%)	0
Pyrexia * 1	0/333 (0.00%)	0	0/69 (0.00%)	0	1/70 (1.43%)	1	0/69 (0.00%)	0
Infections and infestations
Cellulitis * 1	3/333 (0.90%)	3	0/69 (0.00%)	0	0/70 (0.00%)	0	0/69 (0.00%)	0
Pneumonia * 1	2/333 (0.60%)	2	0/69 (0.00%)	0	1/70 (1.43%)	1	0/69 (0.00%)	0
Pneumonia pneumococcal * 1	1/333 (0.30%)	1	0/69 (0.00%)	0	0/70 (0.00%)	0	0/69 (0.00%)	0
Upper respiratory tract infection * 1	1/333 (0.30%)	1	0/69 (0.00%)	0	0/70 (0.00%)	0	0/69 (0.00%)	0
Pyelonephritis * 1	1/333 (0.30%)	1	0/69 (0.00%)	0	0/70 (0.00%)	0	0/69 (0.00%)	0
Oral candidiasis * 1	0/333 (0.00%)	0	0/69 (0.00%)	0	1/70 (1.43%)	1	0/69 (0.00%)	0
Herpes pharyngitis * 1	0/333 (0.00%)	0	0/69 (0.00%)	0	1/70 (1.43%)	1	0/69 (0.00%)	0
Kidney infection * 1	0/333 (0.00%)	0	0/69 (0.00%)	0	1/70 (1.43%)	1	0/69 (0.00%)	0
Injury, poisoning and procedural complications
Drug toxicity * 1	1/333 (0.30%)	1	0/69 (0.00%)	0	0/70 (0.00%)	0	0/69 (0.00%)	0
Musculoskeletal and connective tissue disorders
Bursitis * 1	1/333 (0.30%)	1	0/69 (0.00%)	0	0/70 (0.00%)	0	0/69 (0.00%)	0
Osteoarthritis * 1	1/333 (0.30%)	1	0/69 (0.00%)	0	0/70 (0.00%)	0	0/69 (0.00%)	0
Lupus-like syndrome * 1	0/333 (0.00%)	0	0/69 (0.00%)	0	1/70 (1.43%)	2	0/69 (0.00%)	0
Back pain * 1	0/333 (0.00%)	0	0/69 (0.00%)	0	1/70 (1.43%)	1	0/69 (0.00%)	0
Musculoskeletal chest pain * 1	0/333 (0.00%)	0	1/69 (1.45%)	1	0/70 (0.00%)	0	0/69 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma * 1	1/333 (0.30%)	1	0/69 (0.00%)	0	0/70 (0.00%)	0	0/69 (0.00%)	0
Psychiatric disorders
Depression * 1	1/333 (0.30%)	1	0/69 (0.00%)	0	0/70 (0.00%)	0	0/69 (0.00%)	0
Renal and urinary disorders
Renal failure acute * 1	1/333 (0.30%)	1	0/69 (0.00%)	0	0/70 (0.00%)	0	0/69 (0.00%)	0
Reproductive system and breast disorders
Pelvic peritoneal adhesions * 1	0/333 (0.00%)	0	0/69 (0.00%)	0	1/70 (1.43%)	1	0/69 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea * 1	1/333 (0.30%)	1	0/69 (0.00%)	0	0/70 (0.00%)	0	0/69 (0.00%)	0
Epistaxis * 1	1/333 (0.30%)	1	0/69 (0.00%)	0	0/70 (0.00%)	0	0/69 (0.00%)	0
Painful respiration * 1	1/333 (0.30%)	1	0/69 (0.00%)	0	0/70 (0.00%)	0	0/69 (0.00%)	0
Skin and subcutaneous tissue disorders
Dermal cyst * 1	0/333 (0.00%)	0	1/69 (1.45%)	1	0/70 (0.00%)	0	0/69 (0.00%)	0
Surgical and medical procedures
Implantable defibrillator insertion * 1	1/333 (0.30%)	1	0/69 (0.00%)	0	0/70 (0.00%)	0	0/69 (0.00%)	0
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA (11.1)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Run-in Overall		Certolizumab Pegol 400 mg and Placebo + Methotrexate		Certolizumab Pegol 200 mg and Placebo + Methotrexate		Placebo + Methotrexate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	80/333 (24.02%)		20/69 (28.99%)		12/70 (17.14%)		27/69 (39.13%)
Infections and infestations
Nasopharyngitis * 1	7/333 (2.10%)	7	1/69 (1.45%)	1	1/70 (1.43%)	1	4/69 (5.80%)	4
Upper respiratory tract infection * 1	42/333 (12.61%)	46	8/69 (11.59%)	8	5/70 (7.14%)	6	10/69 (14.49%)	11
Urinary tract infection * 1	27/333 (8.11%)	31	6/69 (8.70%)	6	5/70 (7.14%)	5	7/69 (10.14%)	8
Musculoskeletal and connective tissue disorders
Arthralgia * 1	10/333 (3.00%)	12	5/69 (7.25%)	5	1/70 (1.43%)	1	2/69 (2.90%)	2
Rheumatoid arthritis * 1	9/333 (2.70%)	10	2/69 (2.90%)	2	1/70 (1.43%)	2	6/69 (8.70%)	6
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA (11.1)

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):

Furst DE, Shaikh SA, Greenwald M, Bennett B, Davies O, Luijtens K, Staelens F, Koetse W, Bertin P. Two dosing regimens of certolizumab pegol in patients with active rheumatoid arthritis. Arthritis Care Res (Hoboken). 2015 Feb;67(2):151-60. doi: 10.1002/acr.22496.

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00580840
• Other Study ID Numbers: C87077; 2007-005288-86 ( EudraCT Number )
• First Submitted: December 21, 2007
• First Posted: December 27, 2007
• Results First Submitted: December 14, 2011
• Results First Posted: March 19, 2012
• Last Update Posted: August 2, 2018