| Primary | Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period | 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. | | Posted | | Number | | percentage of participants | | From Entry Visit up to approximately 144 weeks | | | | ID | Title | Description |
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| OG000 | 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. |
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| Primary | Percentage of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) During The Study Period | 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. | | Posted | | Number | | percentage of participants | | From Entry Visit up to approximately 144 weeks | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Percentage of Subjects With DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Completion/Withdrawal 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. | 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. | Posted | | Number | | percentage of participants | | Completion/Withdrawal Visit (up to approximately Week 136) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Completion/Withdrawal 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. | 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. | Posted | | Number | | percentage of participants | | Completion/Withdrawal Visit (up to approximately Week 136) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Percentage of Subjects With SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Completion/Withdrawal 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. | 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. | Posted | | Number | | percentage of participants | | Completion/Withdrawal Visit (up to approximately Week 136) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Percentage of Subjects With ACR20 (American College of Rheumatology 20 % Improvement) Response at Completion/Withdrawal 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. | 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. | Posted | | Number | | percentage of participants | | Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Percentage of Subjects With ACR50 (American College of Rheumatology 50 % Improvement) Response at Completion/Withdrawal 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. | 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. | Posted | | Number | | percentage of participants | | Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Percentage of Subjects With ACR70 (American College of Rheumatology 70 % Improvement) Response at Completion/Withdrawal 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. | 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. | Posted | | Number | | percentage of participants | | Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) at Completion/Withdrawal 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. | 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. | Posted | | Median | Standard Deviation | units on a scale | | Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Change From Baseline in PtAAP (Patient's Assessment of Arthritis Pain) at Completion/Withdrawal 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Change From Baseline in FAS (Fatigue Assessment Scale) at Completion/Withdrawal 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Completion/Withdrawal 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to Week approximately 136) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Geometric Mean of Plasma Concentration of Certolizumab Pegol at Week 24 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). | 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. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | Week 24 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | 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 | Antibody positive is defined as Anti-CZP antibody levels > 2.4 units/mL at any visit. | | Posted | | Number | | percentage of participants | | Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Percentage of Subjects Willing to Self-inject at Week 0 | The percentage of subjects willing to self-inject at Week 0 will be presented using the Full Analysis Set. | | Posted | | Number | | percentage of participants | | Week 0 of this study (C87080 [NCT00843778]) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Mean PRE-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0 | 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 0 of this study (C87080 [NCT00843778]) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0 | 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 0 of this study (C87080 [NCT00843778]) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 2 | 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 2 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 4 | 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 4 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 6 | 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 6 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 8 | 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 8 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 10 | 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 10 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 | 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 12 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 0 | 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 0 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 2 | 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 2 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 4 | 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 4 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 6 | 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 6 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 8 | 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 8 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 10 | 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 10 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 12 | 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 12 | | | | ID | Title | Description |
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| OG000 | 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. |
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