Back to resultsMultiple Dose Study of UCB4940 as add-on to Certolizumab Pegol in Subjects With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Bimekizumab
Certolizumab Pegol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
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.
Sites / Locations
- Ra0123 101
- Ra0123 203
- Ra0123 201
- Ra0123 202
- Ra0123 204
- Ra0123 801
- Ra0123 303
- Ra0123 306
- Ra0123 304
- Ra0123 305
- Ra0123 301
- Ra0123 403
- Ra0123 404
- Ra0123 405
- Ra0123 406
- Ra0123 408
- Ra0123 407
- Ra0123 402
- Ra0123 410
- Ra0123 501
- Ra0123 601
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Other
Arm Label
CZP / CZP + PBO / CZP
CZP / CZP + UCB4940 / CZP
CZP / CZP/ CZP
Arm Description
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
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
Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two Weeks) until Week 30
Outcomes
Primary Outcome Measures
Incidence of Adverse Events
All adverse events (AEs) are recorded during the entire study period.
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.
Secondary Outcome Measures
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).
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).
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).
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).
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.
Full Information
NCT ID
NCT02430909
First Posted
April 27, 2015
Last Updated
May 29, 2017
Sponsor
UCB Celltech
Collaborators
PRA Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02430909
Brief Title
Multiple Dose Study of UCB4940 as add-on to Certolizumab Pegol in Subjects With Rheumatoid Arthritis
Official Title
A Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Multiple Doses of UCB4940 Administered as Add-on to Certolizumab Pegol Therapy in Subjects With Moderate-to-Severe Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Celltech
Collaborators
PRA Health Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
159 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CZP / CZP + PBO / CZP
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
CZP / CZP + UCB4940 / CZP
Arm Type
Experimental
Arm Description
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
Arm Title
CZP / CZP/ CZP
Arm Type
Other
Arm Description
Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two Weeks) until Week 30
Intervention Type
Biological
Intervention Name(s)
Bimekizumab
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Certolizumab Pegol
Intervention Description
Pharmaceutical form: Prefilled syringes
Concentration: 200 mg/ml
Route of administration: Subcutaneous injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Pharmaceutical form: Solution for infusion
Concentration: 0.9% saline
Route of administration: Intravenous infusion
Primary Outcome Measure Information:
Title
Incidence of Adverse Events
Description
All adverse events (AEs) are recorded during the entire study period.
Time Frame
Screening (D-28) until final study visit (Week 44)
Title
Change from Baseline 2 in DAS28(CRP)
Description
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
Secondary Outcome Measure Information:
Title
Percent improvement in ACR (American College of Rheumatology) criteria (ACRn) based on Baseline 2
Description
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
Title
ACR20 response based on Baseline 2
Description
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
Title
ACR50 response based on Baseline 2
Description
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).
Time Frame
Week 20
Title
ACR70 response based on Baseline 2
Description
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
Title
DAS28(CRP) remission
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
+1 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Ra0123 101
City
Praha 7
Country
Czechia
Facility Name
Ra0123 203
City
Balatonfured
Country
Hungary
Facility Name
Ra0123 201
City
Budapest
Country
Hungary
Facility Name
Ra0123 202
City
Budapest
Country
Hungary
Facility Name
Ra0123 204
City
Budapest
Country
Hungary
Facility Name
Ra0123 801
City
Chisinau
Country
Moldova, Republic of
Facility Name
Ra0123 303
City
Bialystok
Country
Poland
Facility Name
Ra0123 306
City
Lublin
Country
Poland
Facility Name
Ra0123 304
City
Poznan
Country
Poland
Facility Name
Ra0123 305
City
Poznan
Country
Poland
Facility Name
Ra0123 301
City
Warszawa
Country
Poland
Facility Name
Ra0123 403
City
Moscow
Country
Russian Federation
Facility Name
Ra0123 404
City
Moscow
Country
Russian Federation
Facility Name
Ra0123 405
City
Moscow
Country
Russian Federation
Facility Name
Ra0123 406
City
Moscow
Country
Russian Federation
Facility Name
Ra0123 408
City
Moscow
Country
Russian Federation
Facility Name
Ra0123 407
City
Saint Petersburg
Country
Russian Federation
Facility Name
Ra0123 402
City
Yaroslavl
Country
Russian Federation
Facility Name
Ra0123 410
City
Yaroslavl
Country
Russian Federation
Facility Name
Ra0123 501
City
Bratislava
Country
Slovakia
Facility Name
Ra0123 601
City
Glasgow
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
31177099
Citation
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.
Results Reference
derived
Learn more about this trial
Multiple Dose Study of UCB4940 as add-on to Certolizumab Pegol in Subjects With Rheumatoid Arthritis
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