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Trial record 1 of 1 for:    NCT02430909
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Multiple Dose Study of UCB4940 as add-on to Certolizumab Pegol in Subjects With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT02430909
Recruitment Status : Completed
First Posted : April 30, 2015
Last Update Posted : May 31, 2017
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
UCB Pharma ( UCB Celltech )

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: Bimekizumab Biological: Certolizumab Pegol Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 2015
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: 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

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

Other: Placebo
  • Pharmaceutical form: Solution for infusion
  • Concentration: 0.9% saline
  • Route of administration: Intravenous infusion

Experimental: 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

Biological: 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

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




Primary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: Screening (D-28) until final study visit (Week 44) ]
    All adverse events (AEs) are recorded during the entire study period.

  2. Change from Baseline 2 in DAS28(CRP) [ Time Frame: Week 20 ]
    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 :
  1. Percent improvement in ACR (American College of Rheumatology) criteria (ACRn) based on Baseline 2 [ Time Frame: Week 20 ]
    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).

  2. ACR20 response based on Baseline 2 [ Time Frame: Week 20 ]
    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).

  3. ACR50 response based on Baseline 2 [ Time Frame: Week 20 ]
    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).

  4. ACR70 response based on Baseline 2 [ Time Frame: Week 20 ]
    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).

  5. DAS28(CRP) remission [ Time Frame: Week 20 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02430909


Locations
Show Show 21 study locations
Sponsors and Collaborators
UCB Celltech
PRA Health Sciences
Investigators
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Study Director: UCB Cares +1 844 599 2273 (UCB)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: UCB Celltech
ClinicalTrials.gov Identifier: NCT02430909    
Other Study ID Numbers: RA0123
2014-003307-30 ( EudraCT Number )
First Posted: April 30, 2015    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Certolizumab Pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents