Rheumatoid Arthritis
Conditions
Brief summary
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.
Interventions
BIOLOGICALBimekizumab
* 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
BIOLOGICALCertolizumab Pegol
* Pharmaceutical form: Prefilled syringes * Concentration: 200 mg/ml * Route of administration: Subcutaneous injection
OTHERPlacebo
* Pharmaceutical form: Solution for infusion * Concentration: 0.9% saline * Route of administration: Intravenous infusion
Sponsors
PRA Health Sciences
UCB Celltech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
To be eligible to participate in this study, all of the following criteria must be met: * Subject is informed and given approved written Informed Consent Form (ICF). * Subject is considered reliable and capable of adhering to the protocol. * Subject must have a diagnosis of adult-onset moderate-to-severe RA of at least 6 months' duration as defined by ACR/EULAR 2010 classification criteria. * Subject must have: * ≥6 tender joints (out of 68) * ≥6 swollen joints (out of 66) * CRP≥10.0mg/L . * Subject must have had inadequate response to at least 1 synthetic DMARD. * Subject is at least 18 years and less than 70 years of age at Visit 1 (Screening). * Female subjects must either be: * postmenopausal * permanently sterilized or, * if of childbearing potential, must be willing to use at least 2 effective methods of contraception, * Male subjects with partners of childbearing potential must be willing to use a condom when sexually active, during the study and for 5 months after last administration of study drug.
Exclusion criteria
Subjects are not permitted to enroll in the study if any of the following criteria is met: * Subject has previously participated in this study or has previously been assigned to treatment in a study of the investigational medicinal product (IMP) under investigation in this study (UCB4940 and/or CZP). * Subject has a history or active systemic/respiratory infection due to fungal, parasitic, or mycotic pathogens. * Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent TB infection are excluded. * Subject is at high risk of infection. * Subject has an active infection or has had a serious infection within 12 weeks prior to the first dose of study drug at Week 0. * Subject has renal or liver impairment. * Subject has a current or past history of gastrointestinal ulceration. * Subject has active neoplastic disease or history of neoplastic disease. * Subject has a concomitant diagnosis of any other inflammatory condition. * Subject has a secondary, non-inflammatory condition or a known diagnosis of fibromyalgia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | Screening (D-28) until final study visit (Week 44) | All adverse events (AEs) are recorded during the entire study period. |
| Change from Baseline 2 in DAS28(CRP) | Week 20 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ACR50 response based on Baseline 2 | Week 20 | 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). |
| Percent improvement in ACR (American College of Rheumatology) criteria (ACRn) based on Baseline 2 | Week 20 | 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). |
| DAS28(CRP) remission | Week 20 | 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. |
| ACR70 response based on Baseline 2 | Week 20 | 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). |
| ACR20 response based on Baseline 2 | Week 20 | 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). |
Countries
Czechia, Hungary, Moldova, Poland, Russia, Slovakia, United Kingdom
Outcome results
None listed