Multiple Dose Study of UCB4940 as add-on to Certolizumab Pegol in Subjects With Rheumatoid Arthritis
NCT ID: NCT02430909
Last Updated: 2017-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
159 participants
INTERVENTIONAL
2015-04-30
2017-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CZP / CZP + PBO / CZP
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
* Pharmaceutical form: Prefilled syringes
* Concentration: 200 mg/ml
* Route of administration: Subcutaneous injection
Placebo
* Pharmaceutical form: Solution for infusion
* Concentration: 0.9% saline
* Route of administration: Intravenous infusion
CZP / CZP + UCB4940 / CZP
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
Bimekizumab
* 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
Certolizumab Pegol
* Pharmaceutical form: Prefilled syringes
* Concentration: 200 mg/ml
* Route of administration: Subcutaneous injection
CZP / CZP/ CZP
Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two Weeks) until Week 30
Certolizumab Pegol
* Pharmaceutical form: Prefilled syringes
* Concentration: 200 mg/ml
* Route of administration: Subcutaneous injection
Interventions
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Bimekizumab
* 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
Certolizumab Pegol
* Pharmaceutical form: Prefilled syringes
* Concentration: 200 mg/ml
* Route of administration: Subcutaneous injection
Placebo
* Pharmaceutical form: Solution for infusion
* Concentration: 0.9% saline
* Route of administration: Intravenous infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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PRA Health Sciences
INDUSTRY
UCB Celltech
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
+1 844 599 2273 (UCB)
Locations
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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
Countries
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References
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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.
Other Identifiers
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2014-003307-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RA0123
Identifier Type: -
Identifier Source: org_study_id
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