Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Moderate to Low Disease Activity, Certolizumab Pegol
Brief summary
To continue to assess the clinical safety and efficacy of Certolizumab Pegol as add-on therapy with stable-dose Disease Modifying Anti-Rheumatic Drugs (DMARDs)
Detailed description
This is a Phase IIIB, multi-centre, open-label, follow-up study to study C87076 \[NCT00674362\] designed to continue to assess the safety and efficacy of Certolizumab Pegol. Two different population will enter the study from C87076 \[NCT00674362\] and will be treated with Certolizumab Pegol every two weeks until it is commercially available for the indication of Rheumatoid Arthritis (RA) in the subject's country or region or until further notice from UCB: Population 1: Are those subjects who failed to achieve remission at Week 20 and/or Week 24 and who completed the Week 24 assessment of study C86076 \[NCT00674362\].The Week 24 assessment (visit 14) of C87076 \[NCT00674362\] will also be the entry assessment (visit 1) for C87080. The subjects will receive Certolizumab Pegol 200 mg every two weeks. No induction period will be applied to ensure the blinding of study C87076 \[NCT00674362\]. Population 2: Are those subjects who achieved remission at both Week 20 and Week 24, flared up between Week 24 and Week 52 and completed the Week 52 assessment in study C87076 \[NCT00674362\]. The Week 52 assessment (visit 26) of C87076 \[NCT00674362\] will also be the entry assessment (visit 1) for C87080. Subjects who flared prior to Week 48 in the C87076 \[NCT00674362\] study will receive Certolizumab Pegol 200 mg every two weeks in the C87080 study. Those who flared at Week 48 or Week 52, 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.
Interventions
BIOLOGICALCertolizumab Pegol
200 mg every two weeks Certolizuimab Pegol 200 mg every two weeks 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.
Sponsors
UCB Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with established adult rheumatoid arthritis on Disease Modifying Anti-Rheumatic Drugs (DMARDs) therapy who were included in C87076 protocol and: * either failed to achieve remission after 6 months of study treatment * or flared after the 6 months of study treatment and completed the study (C87076 \[NCT00674362\])
Exclusion criteria
* All the concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment * Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period | From Entry Visit up to approximately 144 weeks | 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. |
| Percentage of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) During The Study Period | From Entry Visit up to approximately 144 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Completion/Withdrawal Visit | Completion/Withdrawal Visit (up to approximately Week 136) | 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. |
| Percentage of Subjects With ACR20 (American College of Rheumatology 20 % Improvement) Response at Completion/Withdrawal Visit | Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136) | 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. |
| Percentage of Subjects With ACR50 (American College of Rheumatology 50 % Improvement) Response at Completion/Withdrawal Visit | Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136) | 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. |
| Percentage of Subjects With ACR70 (American College of Rheumatology 70 % Improvement) Response at Completion/Withdrawal Visit | Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136) | 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. |
| Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) at Completion/Withdrawal Visit | Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136) | 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. |
| Change From Baseline in PtAAP (Patient's Assessment of Arthritis Pain) at Completion/Withdrawal Visit | Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136) | 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. |
| Change From Baseline in FAS (Fatigue Assessment Scale) at Completion/Withdrawal Visit | Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136) | 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. |
| Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Completion/Withdrawal Visit | Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to Week approximately 136) | 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. |
| Geometric Mean of Plasma Concentration of Certolizumab Pegol at Week 24 Visit | Week 24 | 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). |
| 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 | Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136) | Antibody positive is defined as Anti-CZP antibody levels \> 2.4 units/mL at any visit. |
| Percentage of Subjects Willing to Self-inject at Week 0 | Week 0 of this study (C87080 [NCT00843778]) | The percentage of subjects willing to self-inject at Week 0 will be presented using the Full Analysis Set. |
| Mean PRE-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0 | Week 0 of this study (C87080 [NCT00843778]) | 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. |
| Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0 | Week 0 of this study (C87080 [NCT00843778]) | 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. |
| Percentage of Subjects With DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Completion/Withdrawal Visit | Completion/Withdrawal Visit (up to approximately Week 136) | 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. |
| Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 4 | 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. |
| Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 6 | 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. |
| Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 8 | 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. |
| Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 10 | 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. |
| Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 | 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. |
| Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 0 | 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. |
| Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 2 | 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. |
| Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 4 | 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. |
| Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 6 | 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. |
| Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 8 | 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. |
| Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 10 | 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. |
| Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 12 | 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. |
| Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 2 | 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. |
| Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Completion/Withdrawal Visit | Completion/Withdrawal Visit (up to approximately Week 136) | 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. |
Countries
Austria, France, Germany, Italy, Poland
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 130 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 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
| Characteristic | Certolizumab Pegol |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 113 Participants |
| Age, Continuous | 52.8 years STANDARD_DEVIATION 12.3 |
| Region of Enrollment Austria | 15 participants |
| Region of Enrollment France | 3 participants |
| Region of Enrollment Germany | 28 participants |
| Region of Enrollment Italy | 7 participants |
| Region of Enrollment Poland | 77 participants |
| Sex: Female, Male Female | 105 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 35 / 130 |
| serious Total, serious adverse events | 25 / 130 |
Outcome results
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.
Time frame: From Entry Visit up to approximately 144 weeks
Population: Safety Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period | 70.8 percentage of participants |
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.
Time frame: From Entry Visit up to approximately 144 weeks
Population: Safety Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) During The Study Period | 19.2 percentage of participants |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol | Change From Baseline in FAS (Fatigue Assessment Scale) at Completion/Withdrawal Visit | -1.23 units on a scale | Standard Deviation 2.43 |
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol | 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
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol | 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
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol | 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
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).
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Certolizumab Pegol | Geometric Mean of Plasma Concentration of Certolizumab Pegol at Week 24 Visit | 17.091 μg/mL |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol | Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 0 | 9.588 units on a scale | Standard Deviation 0.471 |
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.
Time frame: Week 10
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol | Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 10 | 9.771 units on a scale | Standard Deviation 0.335 |
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.
Time frame: Week 12
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol | Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 12 | 9.611 units on a scale | Standard Deviation 0.652 |
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.
Time frame: Week 2
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol | Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 2 | 9.688 units on a scale | Standard Deviation 0.448 |
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.
Time frame: Week 4
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol | Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 4 | 9.804 units on a scale | Standard Deviation 0.34 |
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.
Time frame: Week 6
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol | Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 6 | 9.705 units on a scale | Standard Deviation 0.388 |
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.
Time frame: Week 8
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol | Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 8 | 9.634 units on a scale | Standard Deviation 0.423 |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Certolizumab Pegol | 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 1.73 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Certolizumab Pegol | 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 1.79 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 1.36 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 1.1 |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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 |
| Certolizumab Pegol | 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
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.
Time frame: Week 0 of this study (C87080 [NCT00843778])
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects Willing to Self-inject at Week 0 | 69.2 percentage of participants |
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects With ACR20 (American College of Rheumatology 20 % Improvement) Response at Completion/Withdrawal Visit | 57.3 percentage of participants |
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects With ACR50 (American College of Rheumatology 50 % Improvement) Response at Completion/Withdrawal Visit | 35.5 percentage of participants |
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects With ACR70 (American College of Rheumatology 70 % Improvement) Response at Completion/Withdrawal Visit | 15.3 percentage of participants |
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Completion/Withdrawal Visit | 27.9 percentage of participants |
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | 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
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.
Time frame: Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)
Population: Safety Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | 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
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects With SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Completion/Withdrawal Visit | 25.8 percentage of participants |