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Rheumatoid ArthritisPhase 2NCT02430909

Multiple Dose Study of UCB4940 as add-on to Certolizumab Pegol in Subjects With Rheumatoid Arthritis

A Phase 2 study testing Bimekizumab and Certolizumab Pegol in people with Rheumatoid Arthritis, run by UCB Celltech at 21 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Bimekizumab and Certolizumab Pegol
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
159 participants
Where
21 sitesin 7 countries
Study dates
Apr 2015to Apr 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • ≥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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

21 sites in 7 countries.

21 sites in 7 countries

Russia8 sites

  • Ra0123 403

    Moscow

  • Ra0123 404

    Moscow

  • Ra0123 405

    Moscow

  • Ra0123 406

    Moscow

  • Ra0123 408

    Moscow

  • Ra0123 407

    Saint Petersburg

  • Ra0123 402

    Yaroslavl

  • Ra0123 410

    Yaroslavl

Other trials in Russia

Poland5 sites

  • Ra0123 303

    Bialystok

  • Ra0123 306

    Lublin

  • Ra0123 304

    Poznan

  • Ra0123 305

    Poznan

  • Ra0123 301

    Warsaw

Other trials in Poland

Hungary4 sites

  • Ra0123 203

    Balatonfüred

  • Ra0123 201

    Budapest

  • Ra0123 202

    Budapest

  • Ra0123 204

    Budapest

Other trials in Hungary

Czechia1 site

  • Ra0123 101

    Prague

Other trials in Czechia

Moldova1 site

  • Ra0123 801

    Chisinau

Other trials in Moldova

Slovakia1 site

  • Ra0123 501

    Bratislava

Other trials in Slovakia

United Kingdom1 site

  • Ra0123 601

    Glasgow

Other trials in United Kingdom

About this study

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

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.

Being tested
Bimekizumab, Certolizumab Pegol, Placebo
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BimekizumabBiological

    • 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 PegolBiological

    • Pharmaceutical form: Prefilled syringes
    • Concentration: 200 mg/ml
    • Route of administration: Subcutaneous injection

  • PlaceboOther

    • Pharmaceutical form: Solution for infusion
    • Concentration: 0.9% saline
    • Route of administration: Intravenous infusion
Study groups in NCT02430909
Study groupRoleWhat they receive
CZP / CZP + PBO / CZPPlacebo 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
Receives: Biological: Certolizumab Pegol; Other: Placebo
CZP / CZP + UCB4940 / CZPExperimentalCertolizumab 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
Receives: Biological: Bimekizumab; Biological: Certolizumab Pegol
CZP / CZP/ CZPOtherCertolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two Weeks) until Week 30
Receives: Biological: Certolizumab Pegol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events

    All adverse events (AEs) are recorded during the entire study period.

    Measured: Screening (D-28) until final study visit (Week 44)

  2. 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.

    Measured: Week 20

Secondary outcomes (5)

  1. 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).

    Measured: Week 20

  2. 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).

    Measured: Week 20

  3. 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).

    Measured: Week 20

  4. 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).

    Measured: Week 20

  5. 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.

    Measured: Week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionApr 2017
  4. Study completionApr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
159 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02430909
Sponsor's protocol ID
RA0123
Other IDs
2014-003307-30, 2014
Status last verified
May 2017
First submitted
27 Apr 2015
Last updated
31 May 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 31177099

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bimekizumab and Certolizumab Pegol in people with Rheumatoid Arthritis, run by UCB Celltech at 21 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Russia, Poland, Hungary, Czechia, Moldova and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (time frame: Screening (D-28) until final study visit (Week 44)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02430909, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.

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