An open ended study in which patients who completed the preceding double-blind study NCT00160602 are given Certolizumab Pegol and assessed for signs and symptoms of Rheumatoid Arthritis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
567
Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 Years
An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. First dose of CZP was at Baseline of the preceding double-blind study NCT00160602 for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo.
Time frame: From first dose of CZP to the end of the open-label study (approximately 6.8 years)
Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 Years
A SAE is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalisation or prolongation of existing hospitalisation * Results in persistent or significant disability/incapacity, or * Is a congenital anomaly or birth defect * Is as infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above First dose of CZP was at Baseline of the preceding double-blind study NCT00160602 for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo.
Time frame: From first dose of CZP to the end of the open-label study (approximately 6.8 years)
Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study
An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms.
Time frame: From Entry Visit (Week 0) to the end of the study (approximately 6.3 years)
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172
Palm Desert, California, United States
185
Pasadena, California, United States
170
Santa Maria, California, United States
194
Whittier, California, United States
176
Naples, Florida, United States
186
Palm Harbor, Florida, United States
188
Kansas City, Missouri, United States
182
St Louis, Missouri, United States
178
Stratford, New Jersey, United States
192
Amarillo, Texas, United States
...and 57 more locations
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 52
The assessments are based on a 20 % or greater improvement from Baseline to Week 52 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time frame: From Baseline of the preceding double-blind study to Week 52 of the open-label study
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 100
The assessments are based on a 20 % or greater improvement from Baseline to Week 100 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time frame: From Baseline of the preceding double-blind study to Week 100 of the open-label study
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 148
The assessments are based on a 20 % or greater improvement from Baseline to Week 148 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time frame: From Baseline of the preceding double-blind study to Week 148 of the open-label study
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 196
The assessments are based on a 20 % or greater improvement from Baseline to Week 196 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time frame: From Baseline of the preceding double-blind study to Week 196 of the open-label study
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 244
The assessments are based on a 20 % or greater improvement from Baseline to Week 244 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time frame: From Baseline of the preceding double-blind study to Week 244 of the open-label study
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Completion/Withdrawal
The assessments are based on a 20 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)
Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 52
The assessments are based on a 50 % or greater improvement from Baseline to Week 52 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time frame: From Baseline of the preceding double-blind study to Week 52 of the open-label study
Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 100
The assessments are based on a 50 % or greater improvement from Baseline to Week 100 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time frame: From Baseline of the preceding double-blind study to Week 100 of the open-label study
Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 148
The assessments are based on a 50 % or greater improvement from Baseline to Week 148 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time frame: From Baseline of the preceding double-blind study to Week 148 of the open-label study
Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 196
The assessments are based on a 50 % or greater improvement from Baseline to Week 196 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time frame: From Baseline of the preceding double-blind study to Week 196 of the open-label study
Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 244
The assessments are based on a 50 % or greater improvement from Baseline to Week 244 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time frame: From Baseline of the preceding double-blind study to Week 244 of the open-label study
Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Completion/Withdrawal
The assessments are based on a 50 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)
Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 52
The assessments are based on a 70 % or greater improvement from Baseline to Week 52 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time frame: From Baseline of the preceding double-blind study to Week 52 of the open-label study
Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 100
The assessments are based on a 70 % or greater improvement from Baseline to Week 100 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time frame: From Baseline of the preceding double-blind study to Week 100 of the open-label study
Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 148
The assessments are based on a 70 % or greater improvement from Baseline to Week 148 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time frame: From Baseline of the preceding double-blind study to Week 148 of the open-label study
Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 196
The assessments are based on a 70 % or greater improvement from Baseline to Week 196 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time frame: From Baseline of the preceding double-blind study to Week 196 of the open-label study
Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 244
The assessments are based on a 70 % or greater improvement from Baseline to Week 244 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time frame: From Baseline of the preceding double-blind study to Week 244 of the open-label study
Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Completion/Withdrawal
The assessments are based on a 70 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Time frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)
Change From Baseline of the Preceding Double-Blind Study to Week 104 in Modified Total Sharp Score (mTSS)
The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively, as assessed by x-rays of the hands and feet. The score ranges from 0 to 448 with higher scores representing greater damage. A negative value in mTSS change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time frame: From Baseline of the preceding double-blind study to Week 104 of the open-label study
Change From Baseline of the Preceding Double-Blind Study to Completion/Withdrawal Visit in Health Assessment Questionnaire - Disability Index (HAQ-DI) Total Score
The HAQ-DI assesses the degree of difficulty experienced in eight domains (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Gripping, Other Activities) of daily living activities using 20 questions. The HAQ-DI is calculated by summing the domain scores and dividing them by the number of domains. It ranges from 0 (no difficulty) to 3 (unable to do). Negative values indicate an improvement from Baseline to the Post-Baseline Visit with larger negative values showing a better improvement.
Time frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)
Change From Baseline to Completion/Withdrawal Visit in Duration of Morning Stiffness
Morning stiffness is defined as the time in hours elapsed between the time of usual awakening (even if not in the morning) and the time the subject is as limber as he/she will be during a day involving typical activities. A negative value in duration of morning stiffness change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)
Change From Baseline to Completion/Withdrawal Visit in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR])
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. A negative value in DAS28\[ESR\] change from Baseline indicates an improvement from Baseline.
Time frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)
Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit
Good EULAR response is defined as DAS28\[ESR\] improvement from Baseline of the preceding double-blind study \> 1.2 and DAS28\[ESR\] value \< 3.2.
Time frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)
Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Physical Component Summary (PCS) Score
The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept PCS score are scored to yield values between 0 (worst) and 100 (best).
Time frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)
Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Mental Component Summary (MCS) Score
The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept MCS score are scored to yield values between 0 (worst) and 100 (best).
Time frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)