Trial Outcomes & Findings for Follow-up of Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study (NCT NCT00843778)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

131 participants

Primary outcome timeframe

From Entry Visit up to approximately 144 weeks

Results posted on

2014-01-30

Participant Flow

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.

Participant Flow refers to the Enrolled Set consisting of all subjects who gave informed consent.

Participant milestones

Participant milestones
Measure	Certolizumab Pegol 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 Study STARTED	131
Overall Study COMPLETED	96
Overall Study NOT COMPLETED	35

Reasons for withdrawal

Reasons for withdrawal
Measure	Certolizumab Pegol 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 Study Adverse Event	15
Overall Study Lack of Efficacy	14
Overall Study Loss of efficacy	2
Overall Study Withdrawal by Subject	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Certolizumab Pegol n=130 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	113 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants
Age, Continuous	52.8 years STANDARD_DEVIATION 12.3 • n=5 Participants
Sex: Female, Male Female	105 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Region of Enrollment Austria	15 participants n=5 Participants
Region of Enrollment France	3 participants n=5 Participants
Region of Enrollment Germany	28 participants n=5 Participants
Region of Enrollment Italy	7 participants n=5 Participants
Region of Enrollment Poland	77 participants n=5 Participants

PRIMARY outcome

Timeframe: From Entry Visit up to approximately 144 weeks

Population: Safety Set

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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=130 Participants 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.
Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period	70.8 percentage of participants

PRIMARY outcome

Timeframe: From Entry Visit up to approximately 144 weeks

Population: Safety Set

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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=130 Participants 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.
Percentage of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) During The Study Period	19.2 percentage of participants

SECONDARY outcome

Timeframe: Completion/Withdrawal Visit (up to approximately Week 136)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=114 Participants 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.
Percentage of Subjects With DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Completion/Withdrawal Visit	34.2 percentage of participants

SECONDARY outcome

Timeframe: Completion/Withdrawal Visit (up to approximately Week 136)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=122 Participants 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.
Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Completion/Withdrawal Visit	27.9 percentage of participants

SECONDARY outcome

Timeframe: Completion/Withdrawal Visit (up to approximately Week 136)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=120 Participants 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.
Percentage of Subjects With SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Completion/Withdrawal Visit	25.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=124 Participants 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.
Percentage of Subjects With ACR20 (American College of Rheumatology 20 % Improvement) Response at Completion/Withdrawal Visit	57.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=124 Participants 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.
Percentage of Subjects With ACR50 (American College of Rheumatology 50 % Improvement) Response at Completion/Withdrawal Visit	35.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=124 Participants 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.
Percentage of Subjects With ACR70 (American College of Rheumatology 70 % Improvement) Response at Completion/Withdrawal Visit	15.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=119 Participants 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.
Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) at Completion/Withdrawal Visit	-0.36 units on a scale Standard Deviation 0.55

SECONDARY outcome

Timeframe: Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=102 Participants 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.
Change From Baseline in PtAAP (Patient's Assessment of Arthritis Pain) at Completion/Withdrawal Visit	-15.90 units on a scale Standard Deviation 23.72

SECONDARY outcome

Timeframe: Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=117 Participants 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.
Change From Baseline in FAS (Fatigue Assessment Scale) at Completion/Withdrawal Visit	-1.23 units on a scale Standard Deviation 2.43

SECONDARY outcome

Timeframe: Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to Week approximately 136)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=119 Participants 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.
Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Completion/Withdrawal Visit	-13.18 units on a scale Standard Deviation 23.73

SECONDARY outcome

Timeframe: Week 24

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=89 Participants 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.
Geometric Mean of Plasma Concentration of Certolizumab Pegol at Week 24 Visit	17.091 μg/mL Interval 14.981 to 19.499

SECONDARY outcome

Timeframe: Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)

Population: Safety Set

Antibody positive is defined as Anti-CZP antibody levels \> 2.4 units/mL at any visit.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=130 Participants 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.
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	10.0 percentage of participants

SECONDARY outcome

Timeframe: Week 0 of this study (C87080 [NCT00843778])

Population: Full Analysis Set

The percentage of subjects willing to self-inject at Week 0 will be presented using the Full Analysis Set.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=130 Participants 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.
Percentage of Subjects Willing to Self-inject at Week 0	69.2 percentage of participants

SECONDARY outcome

Timeframe: Week 0 of this study (C87080 [NCT00843778])

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=130 Participants 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.
Mean PRE-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0 Feelings about injections (N = 66)	7.929 units on a scale Standard Deviation 1.979
Mean PRE-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0 Self-confidence (N = 66)	5.922 units on a scale Standard Deviation 2.174
Mean PRE-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0 Satisfaction with self-injection (N = 66)	7.462 units on a scale Standard Deviation 2.033

SECONDARY outcome

Timeframe: Week 0 of this study (C87080 [NCT00843778])

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=130 Participants 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.
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0 Feelings about injections (N = 66)	8.093 units on a scale Standard Deviation 1.853
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0 Self-image (N = 66)	8.295 units on a scale Standard Deviation 2.243
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0 Self-confidence (N = 66)	6.881 units on a scale Standard Deviation 1.839
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0 Injection-site reactions (N = 66)	9.206 units on a scale Standard Deviation 1.158
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0 Ease of use (N = 65)	7.376 units on a scale Standard Deviation 1.579
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0 Satisfaction with self-injection (N = 65)	6.994 units on a scale Standard Deviation 0.909

SECONDARY outcome

Timeframe: Week 2

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=130 Participants 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.
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 2 Feelings about injections (N = 81)	8.076 units on a scale Standard Deviation 1.979
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 2 Self-image (N = 80)	8.313 units on a scale Standard Deviation 2.019
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 2 Self-confidence (N = 80)	6.719 units on a scale Standard Deviation 1.905
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 2 Injection-site reactions (N = 81)	8.984 units on a scale Standard Deviation 1.376
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 2 Ease of use (N = 80)	7.250 units on a scale Standard Deviation 1.790
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 2 Satisfaction with self-injection (N =81)	6.847 units on a scale Standard Deviation 1.184

SECONDARY outcome

Timeframe: Week 4

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=130 Participants 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.
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 4 Feelings about injections (N = 83)	8.213 units on a scale Standard Deviation 1.785
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 4 Self-image (N = 83)	8.434 units on a scale Standard Deviation 1.941
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 4 Self-confidence (N = 83)	6.847 units on a scale Standard Deviation 1.707
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 4 Injection-site reactions (N = 82)	9.013 units on a scale Standard Deviation 1.360
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 4 Ease of use (N = 82)	7.512 units on a scale Standard Deviation 1.607
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 4 Satisfaction with self-injection (N = 83)	6.995 units on a scale Standard Deviation 1.100

SECONDARY outcome

Timeframe: Week 6

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=130 Participants 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.
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 6 Feelings about injections (N = 68)	8.407 units on a scale Standard Deviation 1.732
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 6 Self-image (N = 67)	8.545 units on a scale Standard Deviation 1.854
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 6 Self-confidence (N = 68)	6.777 units on a scale Standard Deviation 2.225
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 6 Injection-site reactions (N = 67)	9.025 units on a scale Standard Deviation 1.357
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 6 Ease of use (N = 66)	7.982 units on a scale Standard Deviation 1.308
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 6 Satisfaction with self-injection (N = 68)	7.068 units on a scale Standard Deviation 1.042

SECONDARY outcome

Timeframe: Week 8

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=130 Participants 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.
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 8 Feelings about injections (N = 80)	8.458 units on a scale Standard Deviation 1.635
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 8 Self-image (N = 80)	8.563 units on a scale Standard Deviation 1.769
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 8 Self-confidence (N = 80)	6.854 units on a scale Standard Deviation 1.842
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 8 Injection-site reactions (N = 78)	9.214 units on a scale Standard Deviation 1.144
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 8 Ease of use (N = 79)	7.585 units on a scale Standard Deviation 1.401
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 8 Satisfaction with self-injection (N = 80)	7.112 units on a scale Standard Deviation 0.971

SECONDARY outcome

Timeframe: Week 10

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=130 Participants 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.
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 10 Feelings about injections (N = 74)	8.446 units on a scale Standard Deviation 1.730
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 10 Self-image (N = 72)	8.472 units on a scale Standard Deviation 1.948
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 10 Self-confidence (N = 74)	7.050 units on a scale Standard Deviation 1.852
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 10 Injection-site reactions (N = 73)	8.908 units on a scale Standard Deviation 1.459
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 10 Ease of use (N = 73)	7.792 units on a scale Standard Deviation 1.488
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 10 Satisfaction with self-injection (N = 73)	7.105 units on a scale Standard Deviation 0.876

SECONDARY outcome

Timeframe: Week 12

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=130 Participants 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.
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 Feelings about injections (N = 75)	8.467 units on a scale Standard Deviation 1.673
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 Self-image (N = 74)	8.446 units on a scale Standard Deviation 2.057
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 Self-confidence (N = 75)	7.122 units on a scale Standard Deviation 1.803
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 Injection-site reactions (N = 75)	9.038 units on a scale Standard Deviation 1.513
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 Ease of use (N = 74)	7.973 units on a scale Standard Deviation 1.335
Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 Satisfaction with self-injection (N = 75)	7.127 units on a scale Standard Deviation 0.975

SECONDARY outcome

Timeframe: Week 0

Population: 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.