Multiple Dose Study of UCB4940 as add-on to Certolizumab Pegol in Subjects With Rheumatoid Arthritis
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
2 other identifiers
interventional
159
7 countries
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 rheumatoid-arthritis
Started Apr 2015
Typical duration for phase_2 rheumatoid-arthritis
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 27, 2015
CompletedFirst Posted
Study publicly available on registry
April 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedMay 31, 2017
May 1, 2017
2 years
April 27, 2015
May 29, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (5)
Percent improvement in ACR (American College of Rheumatology) criteria (ACRn) based on Baseline 2
Week 20
ACR20 response based on Baseline 2
Week 20
ACR50 response based on Baseline 2
Week 20
ACR70 response based on Baseline 2
Week 20
DAS28(CRP) remission
Week 20
Study Arms (3)
CZP / CZP + PBO / CZP
PLACEBO COMPARATORCertolizumab 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
EXPERIMENTALCertolizumab 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
OTHERCertolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two Weeks) until Week 30
Interventions
* 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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Celltechlead
- PRA Health Sciencescollaborator
Study Sites (21)
Ra0123 101
Prague, Czechia
Ra0123 203
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
Related Publications (1)
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.
PMID: 31177099DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Cares
+1 844 599 2273 (UCB)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2015
First Posted
April 30, 2015
Study Start
April 1, 2015
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
May 31, 2017
Record last verified: 2017-05