Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003307-30 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| PRA Health Sciences | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CZP / CZP + PBO / CZP | Placebo Comparator | Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two weeks) until Week 30 +Placebo from Week 8 to Week 18 |
|
| CZP / CZP + UCB4940 / CZP | Experimental | Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two weeks) until Week 30 + UCB4940 from Week 8 until Week 18 |
|
| CZP / CZP/ CZP | Other | Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two Weeks) until Week 30 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimekizumab | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | All adverse events (AEs) are recorded during the entire study period. | 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. | Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
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:
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | +1 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ra0123 101 | Prague | Czechia | ||||
| Ra0123 203 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31177099 | Derived | Glatt S, Taylor PC, McInnes IB, Schett G, Landewe R, Baeten D, Ionescu L, Strimenopoulou F, Watling MIL, Shaw S. Efficacy and safety of bimekizumab as add-on therapy for rheumatoid arthritis in patients with inadequate response to certolizumab pegol: a proof-of-concept study. Ann Rheum Dis. 2019 Aug;78(8):1033-1040. doi: 10.1136/annrheumdis-2018-214943. Epub 2019 Jun 8. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Certolizumab Pegol | Biological |
|
|
| Placebo | Other |
|
|
| 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). | 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). | 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). | 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. | Week 20 |
| Balatonfüred |
| Hungary |
| Ra0123 201 | Budapest | Hungary |
| 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 |
| Ra0123 301 | Warsaw | Poland |
| Ra0123 403 | Moscow | Russia |
| Ra0123 404 | Moscow | Russia |
| Ra0123 405 | Moscow | Russia |
| Ra0123 406 | Moscow | Russia |
| Ra0123 408 | Moscow | Russia |
| Ra0123 407 | Saint Petersburg | Russia |
| Ra0123 402 | Yaroslavl | Russia |
| Ra0123 410 | Yaroslavl | Russia |
| Ra0123 501 | Bratislava | Slovakia |
| Ra0123 601 | Glasgow | United Kingdom |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000625981 | bimekizumab |
| D000068582 | Certolizumab Pegol |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D007140 | Immunoglobulin Fab Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided