Follow-up of Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study (CERTAIN 2)

• ClinicalTrials.gov Identifier: NCT00843778
• Recruitment Status: Completed
• First Posted: February 13, 2009
• Results First Posted: October 31, 2013
• Last Update Posted: January 30, 2014
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Rheumatoid Arthritis
• Intervention: Biological: Certolizumab Pegol
• Enrollment: 131

Participant Flow

Recruitment Details	Subjects must have either failed to achieve remission in C87076 [NCT00674362] at Week 20 and/or Week 24 (CDAI >2.8), which was confirmed at Week 24, or must have achieved remission at Week 20, which was confirmed at Week 24, flared up between Week 24 and Week 52 and completed the entire C87076 study through Week 52.
Pre-assignment Details	Participant Flow refers to the Enrolled Set consisting of all subjects who gave informed consent.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Period Title: Overall Study
Started	131
Completed	96
Not Completed	35
Reason Not Completed
Adverse Event	15
Lack of Efficacy	14
Loss of efficacy	2
Withdrawal by Subject	4

Baseline Characteristics

Arm/Group Title		Certolizumab Pegol
Arm/Group Description		Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Baseline Participants		130
Baseline Analysis Population Description		One subject did not receive treatment during C87080, so it is excluded from the Full Analysis Set (FAS) and Safety Set (SS). Full Analysis Set (FAS) consists of all subjects from the Enrolled Set who were dispensed medication. Safety Set is identical to the FAS.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	130 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	113 86.9%
	>=65 years	17 13.1%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	130 participants
		52.8 (12.3)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	130 participants
	Female	105 80.8%
	Male	25 19.2%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants	Number Analyzed	130 participants
Austria		15
France		3
Germany		28
Italy		7
Poland		77

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period
Description	A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases. A TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design). TEAEs are all AEs in which the onset and time is after the first study drug administration in C87080, up to 70 days after the last injection.
Time Frame	From Entry Visit up to approximately 144 weeks

Outcome Measure Data

Analysis Population Description

Safety Set

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	130
Measure Type: Number; Unit of Measure: percentage of participants
	70.8

2. Primary Outcome

Title	Percentage of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) During The Study Period
Description	A Serious Adverse Event is any untoward medical occurrence that at any dose results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect.
Time Frame	From Entry Visit up to approximately 144 weeks

Outcome Measure Data

Analysis Population Description

Safety Set

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	130
Measure Type: Number; Unit of Measure: percentage of participants
	19.2

3. Secondary Outcome

Title	Percentage of Subjects With DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Completion/Withdrawal Visit
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. < 2.6 (Remission), > = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High.
Time Frame	Completion/Withdrawal Visit (up to approximately Week 136)

Outcome Measure Data

Analysis Population Description

Of the 130 subjects in the Full Analysis Set, 114 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	114
Measure Type: Number; Unit of Measure: percentage of participants
	34.2

4. Secondary Outcome

Title	Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Completion/Withdrawal Visit
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. A lower CDAI score indicating improvement in activity and a higher score indicating a decline activity.
Time Frame	Completion/Withdrawal Visit (up to approximately Week 136)

Outcome Measure Data

Analysis Population Description

Of the 130 subjects in the Full Analysis Set, 122 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	122
Measure Type: Number; Unit of Measure: percentage of participants
	27.9

5. Secondary Outcome

Title	Percentage of Subjects With SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Completion/Withdrawal Visit
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. <= 3.3 (Remission), >3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High.
Time Frame	Completion/Withdrawal Visit (up to approximately Week 136)

Outcome Measure Data

Analysis Population Description

Of the 130 subjects in the Full Analysis Set, 120 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	120
Measure Type: Number; Unit of Measure: percentage of participants
	25.8

6. Secondary Outcome

Title	Percentage of Subjects With ACR20 (American College of Rheumatology 20 % Improvement) Response at Completion/Withdrawal Visit
Description	ACR20 response is defined for 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, 5) Physician's Global Assessment of Disease Activity.
Time Frame	Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)

Outcome Measure Data

Analysis Population Description

Of the 130 subjects in the Full Analysis Set, 124 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	124
Measure Type: Number; Unit of Measure: percentage of participants
	57.3

7. Secondary Outcome

Title	Percentage of Subjects With ACR50 (American College of Rheumatology 50 % Improvement) Response at Completion/Withdrawal Visit
Description	ACR50 response is defined for 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, 5) Physician's Global Assessment of Disease Activity.
Time Frame	Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)

Outcome Measure Data

Analysis Population Description

Of the 130 subjects in the Full Analysis Set, 124 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	124
Measure Type: Number; Unit of Measure: percentage of participants
	35.5

8. Secondary Outcome

Title	Percentage of Subjects With ACR70 (American College of Rheumatology 70 % Improvement) Response at Completion/Withdrawal Visit
Description	ACR70 response is defined for 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, 5) Physician's Global Assessment of Disease Activity.
Time Frame	Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)

Outcome Measure Data

Analysis Population Description

Of the 130 subjects in the Full Analysis Set, 124 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	124
Measure Type: Number; Unit of Measure: percentage of participants
	15.3

9. Secondary Outcome

Title	Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) at Completion/Withdrawal Visit
Description	HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living activities (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 Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement.
Time Frame	Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)

Outcome Measure Data

Analysis Population Description

Of the 130 subjects in the Full Analysis Set, 119 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	119
Median (Standard Deviation); Unit of Measure: units on a scale
	-0.36 (0.55)

10. Secondary Outcome

Title	Change From Baseline in PtAAP (Patient's Assessment of Arthritis Pain) at Completion/Withdrawal Visit
Description	Change from Baseline in Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement.
Time Frame	Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)

Outcome Measure Data

Analysis Population Description

Of the 130 subjects in the Full Analysis Set, 102 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	102
Mean (Standard Deviation); Unit of Measure: units on a scale
	-15.90 (23.72)

11. Secondary Outcome

Title	Change From Baseline in FAS (Fatigue Assessment Scale) at Completion/Withdrawal Visit
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 Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement.
Time Frame	Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)

Outcome Measure Data

Analysis Population Description

Of the 130 subjects in the Full Analysis Set, 117 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	117
Mean (Standard Deviation); Unit of Measure: units on a scale
	-1.23 (2.43)

12. Secondary Outcome

Title	Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Completion/Withdrawal Visit
Description	Change from Baseline in Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS) (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement.
Time Frame	Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to Week approximately 136)

Outcome Measure Data

Analysis Population Description

Of the 130 subjects in the Full Analysis Set, 119 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	119
Mean (Standard Deviation); Unit of Measure: units on a scale
	-13.18 (23.73)

13. Secondary Outcome

Title	Geometric Mean of Plasma Concentration of Certolizumab Pegol at Week 24 Visit
Description	Plasma Samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration. Values below the limit of quantification of 0.41 μg/mL will be set to half the limit of quantification for the summaries (0.205 μg/mL).
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

Of the 130 subjects in the Safety Set, 89 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	89
Geometric Mean (95% Confidence Interval); Unit of Measure: μg/mL
	17.091; (14.981 to 19.499)

14. Secondary Outcome

Title	Percentage of Subjects With Positive Anti-Certolizumab Pegol (CZP) Antibody Status at Any Time From Baseline of the Feeder Study C87076 to the Completion/Withdrawal Visit of the Extension Study
Description	Antibody positive is defined as Anti-CZP antibody levels > 2.4 units/mL at any visit.
Time Frame	Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)

Outcome Measure Data

Analysis Population Description

Safety Set

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	130
Measure Type: Number; Unit of Measure: percentage of participants
	10.0

15. Secondary Outcome

Title	Percentage of Subjects Willing to Self-inject at Week 0
Description	The percentage of subjects willing to self-inject at Week 0 will be presented using the Full Analysis Set.
Time Frame	Week 0 of this study (C87080 [NCT00843778])

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	130
Measure Type: Number; Unit of Measure: percentage of participants
	69.2

16. Secondary Outcome

Title	Mean PRE-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0
Description	The three domains of the PRE SIAQ are feelings about injections, self-confidence, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting completed this pre-self-injection questionnaire. The PRE-SIAQ is taken before the subject's first injection.
Time Frame	Week 0 of this study (C87080 [NCT00843778])

Outcome Measure Data

Analysis Population Description

Of the 130 subjects in the Full Analysis Set, 66 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	130
Mean (Standard Deviation); Unit of Measure: units on a scale
Feelings about injections (N = 66)	7.929 (1.979)
Self-confidence (N = 66)	5.922 (2.174)
Satisfaction with self-injection (N = 66)	7.462 (2.033)

17. Secondary Outcome

Title	Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0
Description	The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Time Frame	Week 0 of this study (C87080 [NCT00843778])

Outcome Measure Data

Analysis Population Description

Of the 130 subjects in the Full Analysis Set, 65 or 66 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	130
Mean (Standard Deviation); Unit of Measure: units on a scale
Feelings about injections (N = 66)	8.093 (1.853)
Self-image (N = 66)	8.295 (2.243)
Self-confidence (N = 66)	6.881 (1.839)
Injection-site reactions (N = 66)	9.206 (1.158)
Ease of use (N = 65)	7.376 (1.579)
Satisfaction with self-injection (N = 65)	6.994 (0.909)

18. Secondary Outcome

Title	Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 2
Description	The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

Of the 130 subjects in the Full Analysis Set, 80 or 81subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	130
Mean (Standard Deviation); Unit of Measure: units on a scale
Feelings about injections (N = 81)	8.076 (1.979)
Self-image (N = 80)	8.313 (2.019)
Self-confidence (N = 80)	6.719 (1.905)
Injection-site reactions (N = 81)	8.984 (1.376)
Ease of use (N = 80)	7.250 (1.790)
Satisfaction with self-injection (N =81)	6.847 (1.184)

19. Secondary Outcome

Title	Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 4
Description	The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

Of the 130 subjects in the Full Analysis Set, 82 or 83 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	130
Mean (Standard Deviation); Unit of Measure: units on a scale
Feelings about injections (N = 83)	8.213 (1.785)
Self-image (N = 83)	8.434 (1.941)
Self-confidence (N = 83)	6.847 (1.707)
Injection-site reactions (N = 82)	9.013 (1.360)
Ease of use (N = 82)	7.512 (1.607)
Satisfaction with self-injection (N = 83)	6.995 (1.100)

20. Secondary Outcome

Title	Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 6
Description	The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

Of the 130 subjects in the Full Analysis Set, 66, 67 or 68 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	130
Mean (Standard Deviation); Unit of Measure: units on a scale
Feelings about injections (N = 68)	8.407 (1.732)
Self-image (N = 67)	8.545 (1.854)
Self-confidence (N = 68)	6.777 (2.225)
Injection-site reactions (N = 67)	9.025 (1.357)
Ease of use (N = 66)	7.982 (1.308)
Satisfaction with self-injection (N = 68)	7.068 (1.042)

21. Secondary Outcome

Title	Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 8
Description	The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

Of the 130 subjects in the Full Analysis Set, 78, 79 or 80 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	130
Mean (Standard Deviation); Unit of Measure: units on a scale
Feelings about injections (N = 80)	8.458 (1.635)
Self-image (N = 80)	8.563 (1.769)
Self-confidence (N = 80)	6.854 (1.842)
Injection-site reactions (N = 78)	9.214 (1.144)
Ease of use (N = 79)	7.585 (1.401)
Satisfaction with self-injection (N = 80)	7.112 (0.971)

22. Secondary Outcome

Title	Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 10
Description	The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Time Frame	Week 10

Outcome Measure Data

Analysis Population Description

Of the 130 subjects in the Full Analysis Set, 72, 73 or 74 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	130
Mean (Standard Deviation); Unit of Measure: units on a scale
Feelings about injections (N = 74)	8.446 (1.730)
Self-image (N = 72)	8.472 (1.948)
Self-confidence (N = 74)	7.050 (1.852)
Injection-site reactions (N = 73)	8.908 (1.459)
Ease of use (N = 73)	7.792 (1.488)
Satisfaction with self-injection (N = 73)	7.105 (0.876)

23. Secondary Outcome

Title	Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12
Description	The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Of the 130 subjects in the Full Analysis Set, 74 or 75 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	130
Mean (Standard Deviation); Unit of Measure: units on a scale
Feelings about injections (N = 75)	8.467 (1.673)
Self-image (N = 74)	8.446 (2.057)
Self-confidence (N = 75)	7.122 (1.803)
Injection-site reactions (N = 75)	9.038 (1.513)
Ease of use (N = 74)	7.973 (1.335)
Satisfaction with self-injection (N = 75)	7.127 (0.975)

24. Secondary Outcome

Title	Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 0
Description	The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

Of the 130 subjects in the Full Analysis Set, 31 subjects are included in the analysis of this outcome measure, based upon the number of subjects receiving hospital nurse injection at this visit, with an available assessment score at the visit.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	31
Mean (Standard Deviation); Unit of Measure: units on a scale
	9.588 (0.471)

25. Secondary Outcome

Title	Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 2
Description	The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

Of the 130 subjects in the Full Analysis Set, 36 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	36
Mean (Standard Deviation); Unit of Measure: units on a scale
	9.688 (0.448)

26. Secondary Outcome

Title	Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 4
Description	The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

Of the 130 subjects in the Full Analysis Set, 35 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	35
Mean (Standard Deviation); Unit of Measure: units on a scale
	9.804 (0.340)

27. Secondary Outcome

Title	Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 6
Description	The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

Of the 130 subjects in the Full Analysis Set, 36 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	36
Mean (Standard Deviation); Unit of Measure: units on a scale
	9.705 (0.388)

28. Secondary Outcome

Title	Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 8
Description	The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

Of the 130 subjects in the Full Analysis Set, 34 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	34
Mean (Standard Deviation); Unit of Measure: units on a scale
	9.634 (0.423)

29. Secondary Outcome

Title	Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 10
Description	The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.
Time Frame	Week 10

Outcome Measure Data

Analysis Population Description

Of the 130 subjects in the Full Analysis Set, 37 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	37
Mean (Standard Deviation); Unit of Measure: units on a scale
	9.771 (0.335)

30. Secondary Outcome

Title	Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 12
Description	The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Of the 130 subjects in the Full Analysis Set, 37 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.

Arm/Group Title	Certolizumab Pegol
Arm/Group Description:	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.
Overall Number of Participants Analyzed	37
Mean (Standard Deviation); Unit of Measure: units on a scale
	9.611 (0.652)

Adverse Events

Time Frame	From entry visit up to approximately 144 weeks
Adverse Event Reporting Description	Adverse Events refer to the Safety Set consisting of all enrolled subjects who were dispensed medication.
Arm/Group Title	Certolizumab Pegol
Arm/Group Description	Certolizumab Pegol: 200 mg every two weeks Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection). Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], will receive respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject enters the C87080 study and will be further treated with 200 mg Certolizumab Pegol every two weeks.
All-Cause Mortality
	Certolizumab Pegol
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Certolizumab Pegol
	Affected / at Risk (%)	# Events
Total	25/130 (19.23%)
Cardiac disorders
Myocardial Ischaemia * 1	2/130 (1.54%)	2
Endocrine disorders
Goitre * 1	1/130 (0.77%)	1
Gastrointestinal disorders
Nausea * 1	1/130 (0.77%)	1
General disorders
Asthenia * 1	1/130 (0.77%)	1
Hepatobiliary disorders
Hepatitis Toxic * 1	1/130 (0.77%)	1
Immune system disorders
Anaphylactic Reaction * 1	1/130 (0.77%)	1
Infections and infestations
Respiratory Tract Infection * 1	1/130 (0.77%)	1
Bronchitis Acute * 1	1/130 (0.77%)	1
Subcutaneous Abscess * 1	1/130 (0.77%)	1
Wound Infection Staphylococcal * 1	1/130 (0.77%)	1
Lymph Node Tuberculosis * 1	1/130 (0.77%)	1
Tuberculosis * 1	2/130 (1.54%)	2
Nasopharyngitis * 1	1/130 (0.77%)	1
Pyelonephritis Acute * 1	1/130 (0.77%)	1
Injury, poisoning and procedural complications
Silicosis * 1	1/130 (0.77%)	1
Patella Fracture * 1	1/130 (0.77%)	1
Musculoskeletal and connective tissue disorders
Knee Deformity * 1	1/130 (0.77%)	1
Joint Destruction * 1	1/130 (0.77%)	1
Joint Instability * 1	1/130 (0.77%)	2
Rheumatoid Arthritis * 1	1/130 (0.77%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant * 1	1/130 (0.77%)	1
Basal Cell Carcinoma * 1	1/130 (0.77%)	1
Nervous system disorders
Headache * 1	1/130 (0.77%)	1
Renal and urinary disorders
Nephrolithiasis * 1	1/130 (0.77%)	1
Reproductive system and breast disorders
Colpocele * 1	1/130 (0.77%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea * 1	2/130 (1.54%)	2
Wheezing * 1	1/130 (0.77%)	1
Cough * 1	1/130 (0.77%)	1
Adenoidal Hypertrophy * 1	1/130 (0.77%)	1
Surgical and medical procedures
Hip Arthroplasty * 1	1/130 (0.77%)	1
Knee Arthroplasty * 1	1/130 (0.77%)	1
Vascular disorders
Peripheral Ischaemia * 1	1/130 (0.77%)	1
Hypertension * 1	1/130 (0.77%)	1
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA (9.0)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Certolizumab Pegol
	Affected / at Risk (%)	# Events
Total	35/130 (26.92%)
Gastrointestinal disorders
Diarrhoea * 1	8/130 (6.15%)
Infections and infestations
Nasopharyngitis * 1	8/130 (6.15%)
Pharyngitis * 1	8/130 (6.15%)
Upper respiratory tract infection * 1	12/130 (9.23%)
Urinary tract infection * 1	8/130 (6.15%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA (9.0)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: UCB Clinical Trial Call Center
• Organization: UCB
• Phone: +1 877 822 ext 9493

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00843778
• Other Study ID Numbers: C87080; 2007-000830-38 ( EudraCT Number )
• First Submitted: January 5, 2009
• First Posted: February 13, 2009
• Results First Submitted: August 19, 2013
• Results First Posted: October 31, 2013
• Last Update Posted: January 30, 2014