This study will continue to evaluate the safety \& efficacy of Certolizumab Pegol (CZP) for 6 months in Chinese subjects with active Rheumatoid Arthritis who participated in RA0044.
This study (RA0078) will continue to assess the safety, tolerability, and efficacy of Certolizumab Pegol (CZP) for 6 months as additional medication to methotrexate (MTX) with or without folic acid in Chinese subjects with active Rheumatoid Arthritis (RA) who participated in the main feeder study, RA0044. All subjects will continue to receive their established treatment with MTX with or without folic acid. The dose of MTX may be decreased by the Investigator due to toxicity, but should not be discontinued completely. Concomitant nonsteroidal anti-inflammatory drugs and oral corticosteroids will be permitted. For each subject, the study duration will last a maximum of approximately 32 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
347
Active Substance: Certolizumab Pegol Pharmaceutical form: Prefilled syringes Concentration: 200 mg/ ml Route of Administration: Subcutaneous injection
037
Baotou, China
001
Beijing, China
Percentage of Subjects That Withdrew Due to a Treatment-emergent Adverse Event (TEAE)
TEAEs are defined as Advere Events (AEs) starting on or after the date of first study medication administration in this Open-label Extension (OLE) study up to 70 days post-last dose.
Time frame: Baseline to the end of observation period (32 weeks)
Percentage of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
TEAEs are defined as Adverse Events (AEs) starting on or after the date of first study medication administration in this Open-label Extension (OLE) study up to 70 days post-last dose.
Time frame: Baseline to the end of observation period (32 weeks)
Percentage of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE)
Treatment emergent SAEs are defined as SAEs starting on or after the date of first study medication administration in this OLE study up to 70 days post-last dose.
Time frame: Baseline to the end of observation period (32 weeks)
Percentage of Subjects Meeting the American College of Rheumatology 20 (ACR20) in Relation to Baseline
The ACR20 represents improvement from Baseline of at least 20 %, calculated from assessments of tender joint count, swollen joint count, Patient's Assessment of Arthritis Pain (PtAAP) -visual analog scale (VAS), Patient's Global Assessment of Disease Activity (PtGADA) -VAS, Physician's Global Assessment of Disease Activity (PhGADA) -VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-reactive protein (CRP). Responder was relative to baseline of RA0044. Baseline value in RA0044 was defined as the last non-missing measurement collected prior to first study drug administration in RA0044.
Time frame: Week 24
Percentage of Subjects Meeting the American College of Rheumatology 50 (ACR50) in Relation to Baseline
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002
Beijing, China
013
Beijing, China
021
Beijing, China
025
Beijing, China
033
Beijing, China
014
Bengbu, China
034
Changchun, China
017
Changsha, China
...and 20 more locations
The ACR50 represents improvement from Baseline of at least 50 %, calculated from assessments of tender joint count, swollen joint count, Patient's Assessment of Arthritis Pain (PtAAP) -visual analog scale (VAS), Patient's Global Assessment of Disease Activity (PtGADA) -VAS, Physician's Global Assessment of Disease Activity (PhGADA) -VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-reactive protein (CRP). Responder was relative to baseline of RA0044. Baseline value in RA0044 was defined as the last non-missing measurement collected prior to first study administration in RA0044.
Time frame: Week 24
Percentage of Subjects Meeting the American College of Rheumatology 70 (ACR70) in Relation to Baseline
The ACR70 represents improvement from Baseline of at least 70 %, calculated from assessments of tender joint count, swollen joint count, Patient's Assessment of Arthritis Pain (PtAAP) -visual analog scale (VAS), Patient's Global Assessment of Disease Activity (PtGADA) -VAS, Physician's Global Assessment of Disease Activity (PhGADA) -VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-reactive protein (CRP). Responder was relative to baseline of RA0044. Baseline value in RA0044 was defined as the last non-missing measurement collected prior to first study administration in RA0044.
Time frame: Week 24
Change From Baseline Value in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Each subject will complete the HAQ-DI questionnaire at the visit and provides an assessment of the impact of the disease and its treatment on physical function. HAQ-DI scores range from 0 to 3. Lower scores indicate less disability. Negative values indicate improvement from Baseline. Baseline refers to RA0044 baseline.
Time frame: Week 24