Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Joint Disease, Arthritis, Certolizumab pegol, Cimzia
Brief summary
The purpose of this study is to continue to assess the safety of certolizumab pegol in combination with methotrexate (MTX).
Detailed description
Patients having completed the week 34 assessment in the C87077 (NCT00580840) study or having met the pre-defined criteria for flare (defined as patients that have randomized at Week 18 and experienced at 2 consecutive visits between Week 18 and Week 34 inclusive an equal to Baseline (W0) or worst swollen and tender joints counts), will be given the option to enroll in C87084 and receive certolizumab pegol \[400 mg at Entry, Week 2, and Week 4 followed by 200 mg every two weeks (Q2W)\] in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region or until further notice from UCB. All patients will continue their MTX treatment at the same stable dose as during the C87077 (NCT00580840) study, unless there is a need to reduce the dose for reasons for toxicity.
Interventions
DRUGCertolizumab pegol
Liquid certolizumab pegol administered every two weeks as a single injection (400 mg at Entry, Week 2 & Week 4, followed by 200 mg every 2 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 must be able to understand the written Informed Consent Form (ICF) * Patients must have achieved an ACR20 (American College of Rheumatology) response at Week 16 and completed the entire C87077 (NCT00580840) study or patients having been randomized at Week 18 and having met the pre-defined criteria for flare * Patients must have complied with the protocol requirements during their participation in C87077 (NCT00580840) * Female patients of childbearing potential must have a negative urine pregnancy test at Entry and must continue to have negative urine pregnancy tests throughout their study participation * Patients must be willing to comply with protocol
Exclusion criteria
* Patients must not have a diagnosis of any other inflammatory Arthritis * Patients must not have a secondary, non-inflammatory type of Arthritis that in the investigator's opinion is symptomatic enough to interfere with the evaluation of the study drug on the patient's primary diagnosis of Rheumatoid Arthritis (RA) * Patients must not have a history of an infected joint prosthesis with that prosthesis still in situ * Patients who do not meet the Medical History
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 60 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 date and time is after the first study drug administration in C87084, up to 84 days after the last injection. |
| Percentage of Subjects Withdrawing From Study Due To A Treatment-emergent Adverse Event (TEAE) During The Study Period | From Entry Visit up to approximately 60 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 date and time is after the first study drug administration in C87084, up to 84 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 60 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 |
|---|---|---|
| Change From Baseline in DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) at Completion/Withdrawal Visit | Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) | 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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. \< 2.6 Remission, \> = 2.6 - \< =3.2 Low, \> 3.2 - \< = 5.1 Moderate, \> 5.1 High. |
| Change From Baseline in SDAI (Simplified Disease Activity Index) at Completion/Withdrawal Visit | Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) | 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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. \<= 3.3 Remission, \> 3.3 - \<= 11 Low, \> 11 - \<= 26 Moderate, \> 26 High. |
| Change From Baseline in CDAI (Clinical Disease Activity Index) at Completion/Withdrawal Visit | Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) | 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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. |
| Percentage of Subjects With DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Completion/Withdrawal Visit | Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) | 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. Missing values were imputed using Non-Responder Imputation (NRI). \< 2.6 (Remission), \> = 2.6 - \< =3.2 Low, \> 3.2 - \< = 5.1 Moderate, \> 5.1 High. |
| Percentage of Subjects With SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Completion/Withdrawal Visit | Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) | 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. Missing values were imputed using Non-Responder Imputation (NRI). \<= 3.3 (Remission), \> 3.3 - \<= 11 Low, \> 11 - \<= 26 Moderate, \> 26 High. |
| Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Completion/Withdrawal Visit | Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) | 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. Missing values were imputed using Non-Responder Imputation (NRI). The range for the CDAI is 0 - 76 with a lower CDAI score indicating improvement in activity and a higher score indicating a decline activity. |
| Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) at Completion/Withdrawal Visit | Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) | 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). 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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. |
| Change From Baseline in FAS (Fatigue Assessment Scale) at Completion/Withdrawal Visit | Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) | 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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. |
| Change From Baseline in Physical Functioning (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit | Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) | 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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. |
| Change From Baseline in Role Physical (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit | Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) | 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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. |
| Percentage of Subjects With ACR20 (American College of Rheumatology 20% Improvement) Response at Completion/Withdrawal Visit | Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) | 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. |
| Change From Baseline in General Health (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit | Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) | 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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. |
| Change From Baseline in Vitality (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit | Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) | 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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. |
| Change From Baseline in Social Functioning (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit | Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) | 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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. |
| Change From Baseline in Role Emotional (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit | Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) | 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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. |
| Change From Baseline in Mental Health (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit | Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) | 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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. |
| Change From Baseline in PCS (Short Form 36-item Health Survey Physical Component Summary) at Completion/Withdrawal Visit | Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) | 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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. |
| Change From Baseline in MCS (Short Form 36-item Health Survey Mental Component Summary) at Completion/Withdrawal Visit | Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) | 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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. |
| Change From Baseline in PtAAP (Patient's Assessment of Arthritis Pain) at Completion/Withdrawal Visit | Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) | 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 Completion/Withdrawal 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 PtGADA (Patient's Global Assessment of Disease Activity) at Completion/Withdrawal Visit | Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) | 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 Completion/Withdrawal 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 Bodily Pain (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit | Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) | 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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. |
| Percentage of Subjects With ACR50 (American College of Rheumatology 50% Improvement) Response at Completion/Withdrawal Visit | Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) | 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 C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) | 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. |
Countries
Canada, United States
Participant flow
Recruitment details
The study started in September 2008 with subjects from Canada and the United States. The primary completion date occurred in May 2011, with study completion in May 2011.
Pre-assignment details
Participant Flow and Baseline Characteristics refer to the Full Analysis Set (FAS). The Full Analysis Set (FAS) consists of all subjects who were dispensed medication. One subject was discontinued at the discretion of investigator due to missed visits.
Participants by arm
| Arm | Count |
|---|---|
| CDP870 Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB). | 168 |
| Total | 168 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Investigator Decision | 1 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | CDP870 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 33 Participants |
| Age, Categorical Between 18 and 65 years | 135 Participants |
| Age, Continuous | 53.4 years STANDARD_DEVIATION 12.8 |
| Region of Enrollment Canada | 11 participants |
| Region of Enrollment United States | 157 participants |
| Sex: Female, Male Female | 128 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 23 / 168 |
| serious Total, serious adverse events | 5 / 168 |
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 date and time is after the first study drug administration in C87084, up to 84 days after the last injection.
Time frame: From Entry Visit up to approximately 60 weeks
Population: Of the 168 subjects in the Full Analysis Set (FAS), 168 are included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CDP870 | Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period | 52.4 percentage of subjects |
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 60 weeks
Population: Of the 168 subjects in the Full Analysis Set (FAS), 168 are included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CDP870 | Percentage of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) During The Study Period | 3.0 percentage of subjects |
Primary
Percentage of Subjects Withdrawing From Study Due To A 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 date and time is after the first study drug administration in C87084, up to 84 days after the last injection.
Time frame: From Entry Visit up to approximately 60 weeks
Population: Of the 168 subjects in the Full Analysis Set (FAS), 168 are included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CDP870 | Percentage of Subjects Withdrawing From Study Due To A Treatment-emergent Adverse Event (TEAE) During The Study Period | 2.4 percentage of subjects |
Secondary
Change From Baseline in Bodily Pain (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit
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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)
Population: Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.~Data was not available for 25 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CDP870 | Change From Baseline in Bodily Pain (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit | 12.73 units on a scale | Standard Deviation 8.9 |
Secondary
Change From Baseline in CDAI (Clinical Disease Activity Index) 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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Time frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)
Population: Of the 168 subjects in the Full Analysis Set (FAS), 146 are included in this analysis.~Data was not available for 22 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CDP870 | Change From Baseline in CDAI (Clinical Disease Activity Index) at Completion/Withdrawal Visit | -28.26 units on a scale | Standard Deviation 13.94 |
Secondary
Change From Baseline in DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) 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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. \< 2.6 Remission, \> = 2.6 - \< =3.2 Low, \> 3.2 - \< = 5.1 Moderate, \> 5.1 High.
Time frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)
Population: Of the 168 subjects in the Full Analysis Set (FAS), 142 are included in this analysis.~Data was not available for 26 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CDP870 | Change From Baseline in DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) at Completion/Withdrawal Visit | -2.94 units on a scale | Standard Deviation 1.33 |
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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)
Population: Of the 168 subjects in the Full Analysis Set (FAS), 139 are included in this analysis.~Data was not available for 29 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CDP870 | Change From Baseline in FAS (Fatigue Assessment Scale) at Completion/Withdrawal Visit | -2.58 units on a scale | Standard Deviation 2.51 |
Secondary
Change From Baseline in General Health (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit
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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)
Population: Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.~Data was not available for 27 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CDP870 | Change From Baseline in General Health (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit | 5.1 units on a scale | Standard Deviation 7.9 |
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 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). 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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)
Population: Of the 168 subjects in the Full Analysis Set (FAS), 142 are included in this analysis.~Data was not available for 26 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CDP870 | Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) at Completion/Withdrawal Visit | -0.67 units on a scale | Standard Deviation 0.59 |
Secondary
Change From Baseline in MCS (Short Form 36-item Health Survey Mental Component Summary) at Completion/Withdrawal Visit
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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)
Population: Of the 168 subjects in the Full Analysis Set (FAS), 139 are included in this analysis.~Data was not available for 29 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CDP870 | Change From Baseline in MCS (Short Form 36-item Health Survey Mental Component Summary) at Completion/Withdrawal Visit | 5.82 units on a scale | Standard Deviation 11.3 |
Secondary
Change From Baseline in Mental Health (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit
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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)
Population: Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.~Data was not available for 27 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CDP870 | Change From Baseline in Mental Health (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit | 5.57 units on a scale | Standard Deviation 9.55 |
Secondary
Change From Baseline in PCS (Short Form 36-item Health Survey Physical Component Summary) at Completion/Withdrawal Visit
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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)
Population: Of the 168 subjects in the Full Analysis Set (FAS), 139 are included in this analysis.~Data was not available for 29 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CDP870 | Change From Baseline in PCS (Short Form 36-item Health Survey Physical Component Summary) at Completion/Withdrawal Visit | 10.73 units on a scale | Standard Deviation 8.56 |
Secondary
Change From Baseline in Physical Functioning (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit
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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)
Population: Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.~Data was not available for 25 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CDP870 | Change From Baseline in Physical Functioning (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit | 9.04 units on a scale | Standard Deviation 9.69 |
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-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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)
Population: Of the 168 subjects in the Full Analysis Set (FAS), 140 are included in this analysis.~Data was not available for 28 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CDP870 | Change From Baseline in PtAAP (Patient's Assessment of Arthritis Pain) at Completion/Withdrawal Visit | -36.04 units on a scale | Standard Deviation 27.72 |
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-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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)
Population: Of the 168 subjects in the Full Analysis Set (FAS), 140 are included in this analysis.~Data was not available for 28 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CDP870 | Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Completion/Withdrawal Visit | -35.51 units on a scale | Standard Deviation 27.49 |
Secondary
Change From Baseline in Role Emotional (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit
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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)
Population: Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.~Data was not available for 27 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CDP870 | Change From Baseline in Role Emotional (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit | 7 units on a scale | Standard Deviation 13.56 |
Secondary
Change From Baseline in Role Physical (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit
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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)
Population: Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.~Data was not available for 25 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CDP870 | Change From Baseline in Role Physical (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit | 10.32 units on a scale | Standard Deviation 10.5 |
Secondary
Change From Baseline in SDAI (Simplified Disease Activity Index) 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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. \<= 3.3 Remission, \> 3.3 - \<= 11 Low, \> 11 - \<= 26 Moderate, \> 26 High.
Time frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)
Population: Of the 168 subjects in the Full Analysis Set (FAS), 145 are included in this analysis.~Data was not available for 23 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CDP870 | Change From Baseline in SDAI (Simplified Disease Activity Index) at Completion/Withdrawal Visit | -29.14 units on a scale | Standard Deviation 14.62 |
Secondary
Change From Baseline in Social Functioning (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit
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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)
Population: Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.~Data was not available for 25 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CDP870 | Change From Baseline in Social Functioning (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit | 8.54 units on a scale | Standard Deviation 12.29 |
Secondary
Change From Baseline in Vitality (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit
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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)
Population: Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.~Data was not available for 27 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CDP870 | Change From Baseline in Vitality (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit | 10.27 units on a scale | Standard Deviation 10.27 |
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 C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)
Population: Of the 168 subjects in the Full Analysis Set (FAS), 155 are included in this analysis.~Data was not available for 13 subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CDP870 | Percentage of Subjects With ACR20 (American College of Rheumatology 20% Improvement) Response at Completion/Withdrawal Visit | 73.5 percentage of subjects |
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 C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)
Population: Of the 168 subjects in the Full Analysis Set (FAS), 155 are included in this analysis.~Data was not available for 13 subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CDP870 | Percentage of Subjects With ACR50 (American College of Rheumatology 50% Improvement) Response at Completion/Withdrawal Visit | 59.4 percentage of subjects |
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 C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)
Population: Of the 168 subjects in the Full Analysis Set (FAS), 155 are included in this analysis.~Data was not available for 13 subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CDP870 | Percentage of Subjects With ACR70 (American College of Rheumatology 70% Improvement) Response at Completion/Withdrawal Visit | 39.4 percentage of subjects |
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. Missing values were imputed using Non-Responder Imputation (NRI). The range for the CDAI is 0 - 76 with a lower CDAI score indicating improvement in activity and a higher score indicating a decline activity.
Time frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)
Population: Of the 168 subjects in the Full Analysis Set (FAS), 152 are included in this analysis.~Data was not available for 16 subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CDP870 | Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Completion/Withdrawal Visit | 30.3 percentage of subjects |
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. Missing values were imputed using Non-Responder Imputation (NRI). \< 2.6 (Remission), \> = 2.6 - \< =3.2 Low, \> 3.2 - \< = 5.1 Moderate, \> 5.1 High.
Time frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)
Population: Of the 168 subjects in the Full Analysis Set (FAS), 149 are included in this analysis.~Data was not available for 19 subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CDP870 | Percentage of Subjects With DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Completion/Withdrawal Visit | 32.9 percentage of subjects |
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. Missing values were imputed using Non-Responder Imputation (NRI). \<= 3.3 (Remission), \> 3.3 - \<= 11 Low, \> 11 - \<= 26 Moderate, \> 26 High.
Time frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)
Population: Of the 168 subjects in the Full Analysis Set (FAS), 151 are included in this analysis.~Data was not available for 17 subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CDP870 | Percentage of Subjects With SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Completion/Withdrawal Visit | 31.1 percentage of subjects |