Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, America College of Rheumatology, Disease modifying anti-rheumatic drug, Certolizumab Pegol (CDP870)
Brief summary
The primary purpose of this study is to obtain long-term safety data with CZP in patients with Rheumatoid Arthritis (RA). Additional objectives are to assess the dose and type of Arthritis medication(s) utilized by patients, and to assess the long-term impact of CZP on physical function. Treatment will continue up to approval of a marketing application for this product.
Interventions
BIOLOGICALCertolizumab Pegol
400 mg of Certolizumab Pegol subcutaneously every 4 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
* Participation in CZP trial C87014 or C87011 * If female and of childbearing potential, she agrees to participate in this study by providing written informed consent, has been using adequate contraception since her last menses, will use adequate contraception during the study and for 12 weeks after the last dose of study drug (or longer if required by local regulations), is not lactating, and has had a negative urine pregnancy test on the day of receiving the first dose of study drug * Must have provided written informed consent before undergoing any study procedures
Exclusion criteria
* History (Hx) of chronic infection, serious or life-threatening infection - (including Herpes Zoster) within 6 months prior, or any current symptom indicating infection * Current or recent Hx of severe, progressive and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease * Any finding indicative of Tuberculosis at end of previous study * Known HIV infection * Persistently abnormal AST (Aspartate Aminotransferase) or ALT (Alanine Aminotransferase) results (\> 2 times upper limit of normal) * Hemoglobin (Hgb) levels \< 9 g/dL or Hematocrit \< 30 % * Total White Blood Cell (WBC) count of \< 3.0 x 100/L (\< 3000/mm\^3) * Platelet count \< 100 x 100 L (100,000/mm\^3) * Serum creatinine \> 1.5 times upper limit of normal based on patient age and sex * Receipt of any biological therapies for RA in 6 months prior to study entry or any prior treatment (tx) with Tumor Necrosis Factor (TNF) blocking agent (excluding CDP870) * Receipt of any vaccination (live, attenuated or killed) in 8 weeks prior to Baseline * Any other condition which the Principal Investigator judges would make patient unsuitable for study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With at Least One Adverse Event (AE) During the Study Period of 8 Years | From first dose of CZP up to 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 one of the feeder studies C87011 \[NCT00548834\] or C87014 \[NCT00544154\] for subjects randomized to CZP, or at First Visit (Week 0) of this study for subjects randomized to Placebo. |
| Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study Period of 8 Years | From First Visit (Week 0 in this study) up to 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. The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 160 | From Baseline to Week 160 | The assessments are based on a 20% or greater improvement from Baseline to Week 160 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 respective feeder study. |
| Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 208 | From Baseline to Week 208 | The assessments are based on a 20% or greater improvement from Baseline to Week 208 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 respective feeder study. |
| Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 256 | From Baseline to Week 256 | The assessments are based on a 20% or greater improvement from Baseline to Week 256 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 respective feeder study. |
| Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 316 | From Baseline to Week 316 | The assessments are based on a 20% or greater improvement from Baseline to Week 316 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 respective feeder study. |
| Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Completion Visit or Early Withdrawal Visit | From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years | The assessments are based on a 20% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit 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). |
| Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 52 | From Baseline to 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 respective feeder study. |
| Percentage of Subjects Meeting the American College of Rheumatology 70% Response Criteria (ACR70) at Completion Visit or Early Withdrawal Visit | From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years | The assessments are based on a 70% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit 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). |
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ- DI) at Completion Visit or Early Withdrawal Visit | From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years | 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. |
| Percentage of Subjects Who Withdrew Due to Lack of Efficacy During the Study Period of 8 Years | From First Visit (Week 0 in this study) up to 8 years | — |
| Percentage of Subjects Utilizing Common Additional Arthritis Medications During the Study Period of 8 Years | From First Visit (Week 0 in this study) up to 8 years | This Secondary Outcome Measure shows additional arthritis medications received by at least 20% of subjects during the 8-year study. |
| Percentage of Subjects Meeting the American College of Rheumatology 50% Response Criteria (ACR50) at Completion Visit or Early Withdrawal Visit | From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years | The assessments are based on a 50% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit 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). |
| Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 100 | From Baseline to 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 respective feeder study. |
Countries
Austria, Belgium, Czechia, Germany, Ireland, United Kingdom, United States
Participant flow
Recruitment details
Subjects must have participated in CZP trial C87011 \[NCT00548834\] or C87014 \[NCT00544154\] for at least 12 weeks to be eligible to enter the study. All enrolled subjects who received at least one dose of study medication are included in the Safety Set (SS).
Pre-assignment details
Participant Flow and Baseline Characteristics refer to the Safety Set (SS). Baseline Characteristics were measured at Baseline of the respective feeder study.
Participants by arm
| Arm | Count |
|---|---|
| Certolizumab Pegol 400 mg of Certolizumab Pegol subcutaneously every 4 Weeks. | 402 |
| Total | 402 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 97 |
| Overall Study | Lack of Efficacy | 30 |
| Overall Study | Lost to Follow-up | 15 |
| Overall Study | Protocol Violation | 24 |
| Overall Study | Study terminated by sponsor | 15 |
| Overall Study | Withdrawal by Subject | 54 |
Baseline characteristics
| Characteristic | Certolizumab Pegol |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 75 Participants |
| Age, Categorical Between 18 and 65 years | 327 Participants |
| Age, Continuous | 53.4 years STANDARD_DEVIATION 12.1 |
| Body Mass Index (BMI) | 28.20 kilogram/ meter^2 (kg / m^2) STANDARD_DEVIATION 6.34 |
| Disease Duration | 9.46 years STANDARD_DEVIATION 8.13 |
| Height | 166.4 centimeter (cm) STANDARD_DEVIATION 8.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 17 Participants |
| Race (NIH/OMB) White | 363 Participants |
| Region of Enrollment Austria | 19 participants |
| Region of Enrollment Belgium | 11 participants |
| Region of Enrollment Czech Republic | 81 participants |
| Region of Enrollment Germany | 87 participants |
| Region of Enrollment Ireland | 8 participants |
| Region of Enrollment United Kingdom | 36 participants |
| Region of Enrollment United States | 160 participants |
| Sex: Female, Male Female | 303 Participants |
| Sex: Female, Male Male | 99 Participants |
| Weight | 78.00 kilogram (kg) STANDARD_DEVIATION 17.88 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 348 / 402 |
| serious Total, serious adverse events | 184 / 402 |
Outcome results
Primary
Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study Period of 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. The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms.
Time frame: From First Visit (Week 0 in this study) up to 8 years
Population: Safety Set (SS).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study Period of 8 Years | 24.9 percentage of subjects |
Primary
Percentage of Subjects With at Least One Adverse Event (AE) During the Study Period of 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 one of the feeder studies C87011 \[NCT00548834\] or C87014 \[NCT00544154\] for subjects randomized to CZP, or at First Visit (Week 0) of this study for subjects randomized to Placebo.
Time frame: From first dose of CZP up to 8 years
Population: Safety Set (SS).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects With at Least One Adverse Event (AE) During the Study Period of 8 Years | 93.5 percentage of subjects |
Secondary
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ- DI) at Completion Visit or Early Withdrawal Visit
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 to Completion Visit/ early Withdrawal Visit, up to 8 years
Population: Of the 402 subjects in the Safety Set (SS), 400 subjects are included in this analysis, because they had available data at Baseline and Completion or early Withdrawal Visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Certolizumab Pegol | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ- DI) at Completion Visit or Early Withdrawal Visit | -0.305 units on a scale | Standard Deviation 0.62 |
Secondary
Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Completion Visit or Early Withdrawal Visit
The assessments are based on a 20% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit 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).
Time frame: From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years
Population: Safety Set (SS).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Completion Visit or Early Withdrawal Visit | 57.2 percentage of subjects |
Secondary
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 respective feeder study.
Time frame: From Baseline to Week 100
Population: Of the 402 subjects in the Safety Set (SS), 275 subjects are included in this analysis, because they had available data at Baseline and Week 100.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 100 | 60.0 percentage of subjects |
Secondary
Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 160
The assessments are based on a 20% or greater improvement from Baseline to Week 160 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 respective feeder study.
Time frame: From Baseline to Week 160
Population: Of the 402 subjects in the Safety Set (SS), 247 subjects are included in this analysis, because they had available data at Baseline and Week 160.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 160 | 68.4 percentage of subjects |
Secondary
Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 208
The assessments are based on a 20% or greater improvement from Baseline to Week 208 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 respective feeder study.
Time frame: From Baseline to Week 208
Population: Of the 402 subjects in the Safety Set (SS), 223 subjects are included in this analysis, because they had available data at Baseline and Week 208.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 208 | 72.6 percentage of subjects |
Secondary
Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 256
The assessments are based on a 20% or greater improvement from Baseline to Week 256 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 respective feeder study.
Time frame: From Baseline to Week 256
Population: Of the 402 subjects in the Safety Set (SS), 211 subjects are included in this analysis, because they had available data at Baseline and Week 256.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 256 | 75.4 percentage of subjects |
Secondary
Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 316
The assessments are based on a 20% or greater improvement from Baseline to Week 316 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 respective feeder study.
Time frame: From Baseline to Week 316
Population: Of the 402 subjects in the Safety Set (SS), 140 subjects are included in this analysis, because they had available data at Baseline and Week 316.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 316 | 76.4 percentage of subjects |
Secondary
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 respective feeder study.
Time frame: From Baseline to Week 52
Population: Of the 402 subjects in the Safety Set (SS), 370 subjects are included in this analysis, because they had available data at Baseline and Week 52.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 52 | 58.1 percentage of subjects |
Secondary
Percentage of Subjects Meeting the American College of Rheumatology 50% Response Criteria (ACR50) at Completion Visit or Early Withdrawal Visit
The assessments are based on a 50% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit 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).
Time frame: From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years
Population: Safety Set (SS).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects Meeting the American College of Rheumatology 50% Response Criteria (ACR50) at Completion Visit or Early Withdrawal Visit | 27.6 percentage of subjects |
Secondary
Percentage of Subjects Meeting the American College of Rheumatology 70% Response Criteria (ACR70) at Completion Visit or Early Withdrawal Visit
The assessments are based on a 70% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit 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).
Time frame: From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years
Population: Safety Set (SS).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects Meeting the American College of Rheumatology 70% Response Criteria (ACR70) at Completion Visit or Early Withdrawal Visit | 7.7 percentage of subjects |
Secondary
Percentage of Subjects Utilizing Common Additional Arthritis Medications During the Study Period of 8 Years
This Secondary Outcome Measure shows additional arthritis medications received by at least 20% of subjects during the 8-year study.
Time frame: From First Visit (Week 0 in this study) up to 8 years
Population: Safety Set (SS).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Certolizumab Pegol | Percentage of Subjects Utilizing Common Additional Arthritis Medications During the Study Period of 8 Years | Acetylsalicylic acid | 21.9 percentage of subjects |
| Certolizumab Pegol | Percentage of Subjects Utilizing Common Additional Arthritis Medications During the Study Period of 8 Years | Celecoxib | 22.9 percentage of subjects |
| Certolizumab Pegol | Percentage of Subjects Utilizing Common Additional Arthritis Medications During the Study Period of 8 Years | Diclofenac | 23.4 percentage of subjects |
| Certolizumab Pegol | Percentage of Subjects Utilizing Common Additional Arthritis Medications During the Study Period of 8 Years | Folic acid | 65.2 percentage of subjects |
| Certolizumab Pegol | Percentage of Subjects Utilizing Common Additional Arthritis Medications During the Study Period of 8 Years | Ibuprofen | 26.4 percentage of subjects |
| Certolizumab Pegol | Percentage of Subjects Utilizing Common Additional Arthritis Medications During the Study Period of 8 Years | Methotrexate | 60.9 percentage of subjects |
| Certolizumab Pegol | Percentage of Subjects Utilizing Common Additional Arthritis Medications During the Study Period of 8 Years | Methylprednisolone | 33.8 percentage of subjects |
| Certolizumab Pegol | Percentage of Subjects Utilizing Common Additional Arthritis Medications During the Study Period of 8 Years | Other Immunosuppressive agents | 25.9 percentage of subjects |
| Certolizumab Pegol | Percentage of Subjects Utilizing Common Additional Arthritis Medications During the Study Period of 8 Years | Prednisolone | 20.4 percentage of subjects |
| Certolizumab Pegol | Percentage of Subjects Utilizing Common Additional Arthritis Medications During the Study Period of 8 Years | Prednisone | 39.3 percentage of subjects |
| Certolizumab Pegol | Percentage of Subjects Utilizing Common Additional Arthritis Medications During the Study Period of 8 Years | Paracetamol | 29.6 percentage of subjects |
Secondary
Percentage of Subjects Who Withdrew Due to Lack of Efficacy During the Study Period of 8 Years
Time frame: From First Visit (Week 0 in this study) up to 8 years
Population: Safety Set (SS).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | Percentage of Subjects Who Withdrew Due to Lack of Efficacy During the Study Period of 8 Years | 7.5 percentage of subjects |