Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Moderate to Low Disease activity, Certolizumab pegol
Brief summary
To assess the clinical efficacy and safety of certolizumab pegol as add-on therapy with stable-dose disease-modifying antirheumatic drugs (DMARDs) for achieving clinical remission in patients with moderate to low disease activity rheumatoid arthritis
Detailed description
Treatment period starts with a 24-week, double blind, placebo-controlled, randomized period followed by an open label phase until week 52. In the double blind phase eligible patients will be randomized via an Interactive Voice Response System (IVRS) in a 1:1 ratio to receive either certolizumab pegol (400 mg at Weeks 0, 2 and 4, followed by 200 mg every two weeks) or placebo up to and including Week 22. All patients will continue to receive their Disease Modifying AntiRheumatic Drugs (DMARDs) therapy established before study entry until Week 52. At Week 24, patients will not receive any injection but will be evaluated: * Non-remitters at Week 24 (patients who did not achieve remission at both Week 20 and Week 24) will be discontinued from the study and may be given the opportunity to enter in an open-label follow-up trial, C87080 \[NCT00843778\], with certolizumab pegol. * Remitters (i.e. patients who achieved remission as measured by Clinical Disease Activity Index (CDAI) at both Week 20 and Week 24) will stop their randomized treatment (certolizumab pegol or placebo) and be followed up until Week 52. Remitters who flare up (CDAI ≥11 confirmed at two consecutive visits four weeks apart) between Week 24 and Week 52 will be re-treated with the same dosing regimen of certolizumab pegol (3 administrations of 400mg, given every 2 weeks, followed by 200 mg given every other week) up to and including Week 50. Remitters who flare up between Week 24 and Week 52 and complete 52-week study period will be allowed to enter open label follow up trial at Week 52.
Interventions
BIOLOGICALCertolizumab pegol
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
BIOLOGICALPlacebo
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with established diagnosis of low to moderate adult rheumatoid arthritis, currently on Disease Modifying AntiRheumatic Drugs (DMARDs) therapy for at least six months and not longer than 10 years
Exclusion criteria
* All the concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment, or with the safety of the patient * Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial * Patients must not have received any previous biological therapy for rheumatoid arthritis (RA)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24 | Week 20 and Week 24 | 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 (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24 | Baseline, Week 24 | HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Change from Baseline is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. |
| Change From Baseline in Short Form 36-items Health Survey (SF-36) Vitality Domain at Week 24 | Baseline, Week 24 | There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement |
| Change From Baseline in Short Form 36-items Health Survey (SF-36) Social Functioning Domain at Week 24 | Baseline, Week 24 | There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement |
| Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Emotional Domain at Week 24 | Baseline, Week 24 | There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement |
| Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Health Domain at Week 24 | Baseline, Week 24 | There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement |
| Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (VAS) at Week 24 | Baseline, Week 24 | Change from Baseline in Patient's Assessment of Arthritis Pain-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. |
| Change From Baseline in Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS) at Week 24 | Baseline, Week 24 | Change from Baseline in Patient's Global Assessment of Disease Activity-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. |
| Change From Baseline in Fatigue Assessment Scale at Week 24 | Baseline, Week 24 | Change from Baseline in Fatigue Assessment scale (0 to 10, 0 is No Fatigue and 10 is Fatigue as bad as you can imagine) is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. |
| 28-joint Count Disease Activity Score (DAS28-ESR) Remission (<2.6) at Both Week 20 and Week 24 | Week 20 and Week 24 | 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 (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI) |
| Simplified Disease Activity Index (SDAI) Remission (≤3.3) at Both Week 20 and Week 24 | Week 20 and Week 24 | 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 (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI) |
| Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Clinical Disease Activity Index (CDAI) Scores at 2 Consecutive Visits | Week 24 up to Week 52 | 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 (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Patients losing remission (CDAI \>2.8) for two consecutive visits will be considered as having the event on the day of the visit where remission was first lost. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1. |
| Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Simplified Disease Activity Index (SDAI) Scores at 2 Consecutive Visits | Week 24 up to Week 52 | SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in cm) and Physician's Global Assessment of Disease Activity (PhGADA-VAS in cm). 28 joints are examined. A lower score indicates less disease activity. Patients losing remission (SDAI \>3.3) for two consecutive visits will be considered as having the event on the day of the visit where remission was first lost. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1. |
| Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using DAS28-ESR Scores at 2 Consecutive Visits | Week 24 up to Week 52 | DAS28-ESR is calculated using tender joint count (TJC), swollen joint count (SJC), erythrocyte sedimentation rate (ESR mm/hour) and Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS mm). 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat(ESR) + 0.014xPtGADA-VAS. 28 joints are examined. Lower score indicates less disease activity. Patients losing remission (DAS28-ESR≥2.6) for two consecutive visits will be considered as having the event on the first of the two visits. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1. |
| American College of Rheumatology 20% (ACR20) Response at Week 24 | Baseline, Week 24 | ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI) |
| American College of Rheumatology 50% (ACR50) Response at Week 24 | Baseline, Week 24 | ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI) |
| American College of Rheumatology 70% (ACR70) Response at Week 24 | Baseline, Week 24 | ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI) |
| Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Scores at Week 24 | Baseline, Week 24 | PCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from 1 to 81, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement. |
| Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Component Summary (MCS) Scores at Week 24 | Baseline, Week 24 | MCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from -9 to 82, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement |
| Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Functioning Domain at Week 24 | Baseline, Week 24 | There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement |
| Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Physical Domain at Week 24 | Baseline, Week 24 | There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement |
| Change From Baseline in Short Form 36-items Health Survey (SF-36) Bodily Pain Domain at Week 24 | Baseline, Week 24 | There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement |
| Change From Baseline in Short Form 36-items Health Survey (SF-36) General Health Domain at Week 24 | Baseline, Week 24 | There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement |
Other
| Measure | Time frame | Description |
|---|---|---|
| Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Activity States at Week 24 | Week 24 | The number representing the association is the Kappa Correlation Coefficient for CDAI/DAS28-ESR for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA). |
| Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Activity States at Week 24 | Week 24 | The number representing the association is the Kappa Correlation Coefficient for DAS28-ESR/SDAI for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA). |
| Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Remission at Week 24 | Week 24 | The number representing the association is the Kappa Correlation Coefficient for CDAI/SDAI remission. |
| Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Remission at Week 24 | Week 24 | The number representing the association is the Kappa Correlation Coefficient for CDAI/DAS28-ESR remission |
| Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Remission at Week 24 | Week 24 | The number representing the association is the Kappa Correlation Coefficient for DAS28-ESR/SDAI remission. |
| Time From Stopping Treatment (Week 24) to First Flare (up to Week 52) Using Clinical Disease Activity Index (CDAI) at 2 Consecutive Visits | From Week 24 up to Week 52 | Subjects having a flare (CDAI ≥11) between Week 24 and Week 52 for two consecutive visits will be considered as having the event on the day of the visit where flare first appeared. |
| Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Activity States at Week 24 | Week 24 | The number representing the association is the Kappa Correlation Coefficient for CDAI/SDAI for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA). |
Countries
Austria, France, Germany, Italy, Poland
Participant flow
Recruitment details
The study started in June 2008 with subjects from Germany, France, Austria, Italy, and Poland. The primary completion date occurred in May 2010, with an anticipated study completion in December 2010.
Participants by arm
| Arm | Count |
|---|---|
| Certolizumab Pegol 200 mg (CDP870) Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22) | 96 |
| Placebo Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22) | 98 |
| Total | 194 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Double Blind | Adverse Event | 6 | 6 |
| Double Blind | Lack of Efficacy | 2 | 6 |
| Double Blind | Loss of efficacy | 0 | 1 |
| Double Blind | Other: Loss of Patient Compliance | 0 | 1 |
| Double Blind | Other: Surgery | 0 | 1 |
| Double Blind | Withdrawal by Subject | 4 | 3 |
| Open Label | Adverse Event | 1 | 0 |
| Open Label | Other: Subject moved to extension study | 1 | 0 |
Baseline characteristics
| Characteristic | Certolizumab Pegol 200 mg (CDP870) | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical >=65 years | 18 Participants | 17 Participants | 35 Participants |
| Age, Categorical Between 18 and 65 years | 78 Participants | 80 Participants | 158 Participants |
| Age Continuous | 53.6 years STANDARD_DEVIATION 11.9 | 54.0 years STANDARD_DEVIATION 12.4 | 53.8 years STANDARD_DEVIATION 12.1 |
| Region of Enrollment Austria | 17 participants | 15 participants | 32 participants |
| Region of Enrollment France | 2 participants | 2 participants | 4 participants |
| Region of Enrollment Germany | 31 participants | 31 participants | 62 participants |
| Region of Enrollment Italy | 6 participants | 4 participants | 10 participants |
| Region of Enrollment Poland | 40 participants | 46 participants | 86 participants |
| Sex: Female, Male Female | 81 Participants | 75 Participants | 156 Participants |
| Sex: Female, Male Male | 15 Participants | 23 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 32 / 96 | 34 / 98 | 4 / 27 |
| serious Total, serious adverse events | 5 / 96 | 7 / 98 | 1 / 27 |
Outcome results
Primary
Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24
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 (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI)
Time frame: Week 20 and Week 24
Population: All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24 | 18.8 percentage of subjects |
| Placebo | Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24 | 6.1 percentage of subjects |
Secondary
28-joint Count Disease Activity Score (DAS28-ESR) Remission (<2.6) at Both Week 20 and Week 24
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 (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI)
Time frame: Week 20 and Week 24
Population: Since imputation was used, all 194 subjects are included in the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | 28-joint Count Disease Activity Score (DAS28-ESR) Remission (<2.6) at Both Week 20 and Week 24 | 19.8 percentage of subjects |
| Placebo | 28-joint Count Disease Activity Score (DAS28-ESR) Remission (<2.6) at Both Week 20 and Week 24 | 3.1 percentage of subjects |
Secondary
American College of Rheumatology 20% (ACR20) Response at Week 24
ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)
Time frame: Baseline, Week 24
Population: Since imputation was used, all 194 subjects are included in the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | American College of Rheumatology 20% (ACR20) Response at Week 24 | 36.5 percentage of subjects |
| Placebo | American College of Rheumatology 20% (ACR20) Response at Week 24 | 15.3 percentage of subjects |
Secondary
American College of Rheumatology 50% (ACR50) Response at Week 24
ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)
Time frame: Baseline, Week 24
Population: Since imputation was used, all 194 subjects are included in the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | American College of Rheumatology 50% (ACR50) Response at Week 24 | 20.8 percentage of subjects |
| Placebo | American College of Rheumatology 50% (ACR50) Response at Week 24 | 7.1 percentage of subjects |
Secondary
American College of Rheumatology 70% (ACR70) Response at Week 24
ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)
Time frame: Baseline, Week 24
Population: Since imputation was used, all 194 subjects are included in the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | American College of Rheumatology 70% (ACR70) Response at Week 24 | 9.4 percentage of subjects |
| Placebo | American College of Rheumatology 70% (ACR70) Response at Week 24 | 3.1 percentage of subjects |
Secondary
Change From Baseline in Fatigue Assessment Scale at Week 24
Change from Baseline in Fatigue Assessment scale (0 to 10, 0 is No Fatigue and 10 is Fatigue as bad as you can imagine) is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time frame: Baseline, Week 24
Population: Of the 194 subjects, 180 (90 CZP, 90 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | Change From Baseline in Fatigue Assessment Scale at Week 24 | -1.2 units on a scale | Standard Deviation 2.24 |
| Placebo | Change From Baseline in Fatigue Assessment Scale at Week 24 | 0.1 units on a scale | Standard Deviation 2.12 |
Secondary
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24
HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Change from Baseline is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time frame: Baseline, Week 24
Population: Of the 194 subjects, 182 (91 CZP, 91 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24 | -0.25 units on a scale | Standard Deviation 0.46 |
| Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24 | -0.03 units on a scale | Standard Deviation 0.49 |
Secondary
Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (VAS) at Week 24
Change from Baseline in Patient's Assessment of Arthritis Pain-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time frame: Baseline, Week 24
Population: Of the 194 subjects, 162 (81 CZP, 81 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (VAS) at Week 24 | -12.4 mm | Standard Deviation 25.49 |
| Placebo | Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (VAS) at Week 24 | 1.0 mm | Standard Deviation 24.27 |
Secondary
Change From Baseline in Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS) at Week 24
Change from Baseline in Patient's Global Assessment of Disease Activity-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time frame: Baseline, Week 24
Population: Of the 194 subjects, 183 (92 CZP, 91 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | Change From Baseline in Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS) at Week 24 | -7.6 mm | Standard Deviation 28.69 |
| Placebo | Change From Baseline in Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS) at Week 24 | 2.9 mm | Standard Deviation 25.43 |
Secondary
Change From Baseline in Short Form 36-items Health Survey (SF-36) Bodily Pain Domain at Week 24
There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement
Time frame: Baseline, Week 24
Population: Of the 194 subjects in the Full Analysis Set (FAS), 167 (83 CZP, 84 Placebo) had values at Baseline and Week 24 and are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | Change From Baseline in Short Form 36-items Health Survey (SF-36) Bodily Pain Domain at Week 24 | 8.0 units on a scale | Standard Deviation 8.7 |
| Placebo | Change From Baseline in Short Form 36-items Health Survey (SF-36) Bodily Pain Domain at Week 24 | 2.8 units on a scale | Standard Deviation 8.5 |
Secondary
Change From Baseline in Short Form 36-items Health Survey (SF-36) General Health Domain at Week 24
There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement
Time frame: Baseline, Week 24
Population: Of the 194 subjects in the Full Analysis Set (FAS), 166 (82 CZP, 84 Placebo) had values at Baseline and Week 24 and are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | Change From Baseline in Short Form 36-items Health Survey (SF-36) General Health Domain at Week 24 | 5.0 units on a scale | Standard Deviation 7.59 |
| Placebo | Change From Baseline in Short Form 36-items Health Survey (SF-36) General Health Domain at Week 24 | 0.9 units on a scale | Standard Deviation 8.06 |
Secondary
Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Component Summary (MCS) Scores at Week 24
MCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from -9 to 82, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement
Time frame: Baseline, Week 24
Population: Of the 194 subjects in the Full Analysis Set (FAS), 164 (82 CZP, 82 Placebo) had values at Baseline and Week 24 and are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Component Summary (MCS) Scores at Week 24 | 4.0 units on a scale | Standard Deviation 9.77 |
| Placebo | Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Component Summary (MCS) Scores at Week 24 | 0.5 units on a scale | Standard Deviation 9.26 |
Secondary
Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Health Domain at Week 24
There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement
Time frame: Baseline, Week 24
Population: Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Health Domain at Week 24 | 5.2 units on a scale | Standard Deviation 8.43 |
| Placebo | Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Health Domain at Week 24 | 1.2 units on a scale | Standard Deviation 7.72 |
Secondary
Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Scores at Week 24
PCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from 1 to 81, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement.
Time frame: Baseline, Week 24
Population: Of the 194 subjects in the Full Analysis Set (FAS), 164 (82 CZP, 82 Placebo) had values at Baseline and Week 24 and are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Scores at Week 24 | 6.0 units on a scale | Standard Deviation 7.5 |
| Placebo | Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Scores at Week 24 | 1.7 units on a scale | Standard Deviation 7.56 |
Secondary
Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Functioning Domain at Week 24
There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement
Time frame: Baseline, Week 24
Population: Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Functioning Domain at Week 24 | 5.1 units on a scale | Standard Deviation 7.36 |
| Placebo | Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Functioning Domain at Week 24 | 0.4 units on a scale | Standard Deviation 8.9 |
Secondary
Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Emotional Domain at Week 24
There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement
Time frame: Baseline, Week 24
Population: Of the 194 subjects in the Full Analysis Set (FAS), 166 (83 CZP, 83 Placebo) had values at Baseline and Week 24 and are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Emotional Domain at Week 24 | 3.2 units on a scale | Standard Deviation 13.74 |
| Placebo | Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Emotional Domain at Week 24 | -0.2 units on a scale | Standard Deviation 12.33 |
Secondary
Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Physical Domain at Week 24
There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement
Time frame: Baseline, Week 24
Population: Of the 194 subjects in the Full Analysis Set (FAS), 167 (83 CZP, 84 Placebo) had values at Baseline and Week 24 and are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Physical Domain at Week 24 | 4.7 units on a scale | Standard Deviation 9.77 |
| Placebo | Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Physical Domain at Week 24 | 1.7 units on a scale | Standard Deviation 7.81 |
Secondary
Change From Baseline in Short Form 36-items Health Survey (SF-36) Social Functioning Domain at Week 24
There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement
Time frame: Baseline, Week 24
Population: Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | Change From Baseline in Short Form 36-items Health Survey (SF-36) Social Functioning Domain at Week 24 | 4.3 units on a scale | Standard Deviation 10.21 |
| Placebo | Change From Baseline in Short Form 36-items Health Survey (SF-36) Social Functioning Domain at Week 24 | 0.8 units on a scale | Standard Deviation 8.89 |
Secondary
Change From Baseline in Short Form 36-items Health Survey (SF-36) Vitality Domain at Week 24
There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement
Time frame: Baseline, Week 24
Population: Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | Change From Baseline in Short Form 36-items Health Survey (SF-36) Vitality Domain at Week 24 | 6.4 units on a scale | Standard Deviation 8.74 |
| Placebo | Change From Baseline in Short Form 36-items Health Survey (SF-36) Vitality Domain at Week 24 | 0.6 units on a scale | Standard Deviation 8.41 |
Secondary
Simplified Disease Activity Index (SDAI) Remission (≤3.3) at Both Week 20 and Week 24
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 (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI)
Time frame: Week 20 and Week 24
Population: Since imputation was used, all 194 subjects are included in the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | Simplified Disease Activity Index (SDAI) Remission (≤3.3) at Both Week 20 and Week 24 | 14.6 percentage of subjects |
| Placebo | Simplified Disease Activity Index (SDAI) Remission (≤3.3) at Both Week 20 and Week 24 | 4.1 percentage of subjects |
Secondary
Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Clinical Disease Activity Index (CDAI) Scores at 2 Consecutive Visits
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 (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Patients losing remission (CDAI \>2.8) for two consecutive visits will be considered as having the event on the day of the visit where remission was first lost. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1.
Time frame: Week 24 up to Week 52
Population: All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Clinical Disease Activity Index (CDAI) Scores at 2 Consecutive Visits | 12.1 days | Standard Deviation 2.83 |
| Placebo | Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Clinical Disease Activity Index (CDAI) Scores at 2 Consecutive Visits | 3.4 days | Standard Deviation 1.02 |
Secondary
Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using DAS28-ESR Scores at 2 Consecutive Visits
DAS28-ESR is calculated using tender joint count (TJC), swollen joint count (SJC), erythrocyte sedimentation rate (ESR mm/hour) and Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS mm). 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat(ESR) + 0.014xPtGADA-VAS. 28 joints are examined. Lower score indicates less disease activity. Patients losing remission (DAS28-ESR≥2.6) for two consecutive visits will be considered as having the event on the first of the two visits. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1.
Time frame: Week 24 up to Week 52
Population: All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using DAS28-ESR Scores at 2 Consecutive Visits | 12.1 Days | Standard Deviation 2.96 |
| Placebo | Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using DAS28-ESR Scores at 2 Consecutive Visits | 1.0 Days | Standard Deviation 0 |
Secondary
Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Simplified Disease Activity Index (SDAI) Scores at 2 Consecutive Visits
SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in cm) and Physician's Global Assessment of Disease Activity (PhGADA-VAS in cm). 28 joints are examined. A lower score indicates less disease activity. Patients losing remission (SDAI \>3.3) for two consecutive visits will be considered as having the event on the day of the visit where remission was first lost. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1.
Time frame: Week 24 up to Week 52
Population: All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Simplified Disease Activity Index (SDAI) Scores at 2 Consecutive Visits | 9.8 days | Standard Deviation 2.57 |
| Placebo | Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Simplified Disease Activity Index (SDAI) Scores at 2 Consecutive Visits | 2.1 days | Standard Deviation 0.53 |
Other Pre-specified
Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Activity States at Week 24
The number representing the association is the Kappa Correlation Coefficient for CDAI/DAS28-ESR for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA).
Time frame: Week 24
Population: Of the 194 subjects in the Full Analysis Set (FAS) 148 (79 CZP, 69 Placebo) had measures for both CDAI and DAS28-ESR at Week 24 and are included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Activity States at Week 24 | LDA vs. Non-LDA | 0.08 Kappa Correlation Coefficient |
| Certolizumab Pegol 200 mg (CDP870) | Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Activity States at Week 24 | MDA vs. Non-MDA | 0.36 Kappa Correlation Coefficient |
| Certolizumab Pegol 200 mg (CDP870) | Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Activity States at Week 24 | HDA vs. Non-HDA | 0.54 Kappa Correlation Coefficient |
| Placebo | Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Activity States at Week 24 | HDA vs. Non-HDA | 0.65 Kappa Correlation Coefficient |
| Placebo | Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Activity States at Week 24 | LDA vs. Non-LDA | 0.08 Kappa Correlation Coefficient |
| Placebo | Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Activity States at Week 24 | MDA vs. Non-MDA | 0.44 Kappa Correlation Coefficient |
Other Pre-specified
Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Remission at Week 24
The number representing the association is the Kappa Correlation Coefficient for CDAI/DAS28-ESR remission
Time frame: Week 24
Population: Of the 194 subjects in the Full Analysis Set (FAS) 148 (79 CZP, 69 Placebo) had measures for both CDAI and DAS28-ESR at Week 24 and are included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Remission at Week 24 | 0.53 Kappa Correlation Coefficient |
| Placebo | Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Remission at Week 24 | 0.31 Kappa Correlation Coefficient |
Other Pre-specified
Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Activity States at Week 24
The number representing the association is the Kappa Correlation Coefficient for CDAI/SDAI for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA).
Time frame: Week 24
Population: Of the 194 subjects in the Full Analysis Set (FAS) 143 (76 CZP, 67 Placebo) had measures for both CDAI and SDAI at Week 24 and are included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Activity States at Week 24 | LDA vs. Non-LDA | 0.82 Kappa Correlation Coefficient |
| Certolizumab Pegol 200 mg (CDP870) | Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Activity States at Week 24 | MDA vs. Non-MDA | 0.68 Kappa Correlation Coefficient |
| Certolizumab Pegol 200 mg (CDP870) | Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Activity States at Week 24 | HDA vs. Non-HDA | 0.59 Kappa Correlation Coefficient |
| Placebo | Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Activity States at Week 24 | MDA vs. Non-MDA | 0.71 Kappa Correlation Coefficient |
| Placebo | Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Activity States at Week 24 | LDA vs. Non-LDA | 0.96 Kappa Correlation Coefficient |
| Placebo | Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Activity States at Week 24 | HDA vs. Non-HDA | 0.71 Kappa Correlation Coefficient |
Other Pre-specified
Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Remission at Week 24
The number representing the association is the Kappa Correlation Coefficient for CDAI/SDAI remission.
Time frame: Week 24
Population: Of the 194 subjects in the Full Analysis Set (FAS) 143 (76 CZP, 67 Placebo) had measures for both CDAI and SDAI at Week 24 and are included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Remission at Week 24 | 0.88 Kappa Correlation Coefficient |
| Placebo | Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Remission at Week 24 | 1.00 Kappa Correlation Coefficient |
Other Pre-specified
Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Activity States at Week 24
The number representing the association is the Kappa Correlation Coefficient for DAS28-ESR/SDAI for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA).
Time frame: Week 24
Population: Of the 194 subjects in the Full Analysis Set (FAS) 142 (76 CZP, 66 Placebo) had measures for both DAS28-ESR and SDAI at Week 24 and are included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Activity States at Week 24 | HDA vs. Non-HDA | 0.74 Kappa Correlation Coefficient |
| Certolizumab Pegol 200 mg (CDP870) | Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Activity States at Week 24 | LDA vs. Non-LDA | 0.20 Kappa Correlation Coefficient |
| Certolizumab Pegol 200 mg (CDP870) | Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Activity States at Week 24 | MDA vs. Non-MDA | 0.44 Kappa Correlation Coefficient |
| Placebo | Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Activity States at Week 24 | HDA vs. Non-HDA | 0.91 Kappa Correlation Coefficient |
| Placebo | Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Activity States at Week 24 | LDA vs. Non-LDA | 0.10 Kappa Correlation Coefficient |
| Placebo | Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Activity States at Week 24 | MDA vs. Non-MDA | 0.59 Kappa Correlation Coefficient |
Other Pre-specified
Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Remission at Week 24
The number representing the association is the Kappa Correlation Coefficient for DAS28-ESR/SDAI remission.
Time frame: Week 24
Population: Of the 194 subjects in the Full Analysis Set (FAS) 142 (76 CZP, 66 Placebo) had measures for both DAS28-ESR and SDAI at Week 24 and are included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Remission at Week 24 | 0.61 Kappa Correlation Coefficient |
| Placebo | Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Remission at Week 24 | 0.31 Kappa Correlation Coefficient |
Other Pre-specified
Time From Stopping Treatment (Week 24) to First Flare (up to Week 52) Using Clinical Disease Activity Index (CDAI) at 2 Consecutive Visits
Subjects having a flare (CDAI ≥11) between Week 24 and Week 52 for two consecutive visits will be considered as having the event on the day of the visit where flare first appeared.
Time frame: From Week 24 up to Week 52
Population: All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.~An ad-hoc analysis has been performed on the Week 24 Responder Set (W24RS) which showed similar results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol 200 mg (CDP870) | Time From Stopping Treatment (Week 24) to First Flare (up to Week 52) Using Clinical Disease Activity Index (CDAI) at 2 Consecutive Visits | 82.3 days | Standard Error 10.28 |
| Placebo | Time From Stopping Treatment (Week 24) to First Flare (up to Week 52) Using Clinical Disease Activity Index (CDAI) at 2 Consecutive Visits | 34.5 days | Standard Error 4.93 |