The purpose of this study is to evaluate the safety, efficacy and body distribution of Bimekizumab (UCB4940) when added to Certolizumab Pegol treatment in patients with Rheumatoid Arthritis. Neither the patient nor the doctor will know the treatment group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
159
* Pharmaceutical form: Solution for infusion * Concentration: Vials at 80 mg/ml will be diluted with 0.9% sodium chloride to a final concentration to achieve the correct dose * Route of administration: iv infustion
* Pharmaceutical form: Prefilled syringes * Concentration: 200 mg/ml * Route of administration: Subcutaneous injection
* Pharmaceutical form: Solution for infusion * Concentration: 0.9% saline * Route of administration: Intravenous infusion
Ra0123 101
Prague, Czechia
Ra0123 203
Balatonfüred, Hungary
Ra0123 201
Budapest, Hungary
Incidence of Adverse Events
All adverse events (AEs) are recorded during the entire study period.
Time frame: Screening (D-28) until final study visit (Week 44)
Change from Baseline 2 in DAS28(CRP)
DAS28 (Disease Activity Score 28) is a measure of disease activity in Rheumatoid Arthritis (RA) and is a composite score derived from the number of swollen and tender joints (out of 28), the CRP value and the patient global assessment of disease activity.
Time frame: Week 20
Percent improvement in ACR (American College of Rheumatology) criteria (ACRn) based on Baseline 2
ACRn is the percentage improvement from Baseline 2 in the number of tender joints, in the number of swollen joints, and 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: Week 20
ACR20 response based on Baseline 2
The assessments are based on a 20% or greater improvement from Baseline 2 in the number of tender joints, 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: Week 20
ACR50 response based on Baseline 2
The assessments are based on a 20% or greater improvement from Baseline 2 in the number of tender joints, 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).
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Ra0123 202
Budapest, Hungary
Ra0123 204
Budapest, Hungary
Ra0123 801
Chisinau, Moldova
Ra0123 303
Bialystok, Poland
Ra0123 306
Lublin, Poland
Ra0123 304
Poznan, Poland
Ra0123 305
Poznan, Poland
...and 11 more locations
Time frame: Week 20
ACR70 response based on Baseline 2
The assessments are based on a 20% or greater improvement from Baseline 2 in the number of tender joints, 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: Week 20
DAS28(CRP) remission
DAS28(CRP) remission is defined as DAS28(CRP) \< 2.6. DAS28 is a measure of disease activity in RA and is a composite score derived from the number of swollen and tender joints (out of 28) , the C-reactive protein value and the patient global assessment of disease activity.
Time frame: Week 20