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A Study to Assess the Pharmacokinetics of Certolizumab Pegol in Adults With Active Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Certolizumab pegol
Sponsored by
UCB Biopharma SRL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis, Phase 1, Cimzia, Certolizumab pegol, Electrochemiluminescent immune-assay

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participant must be 18 to 69 years of age inclusive, at the time of signing the informed consent
  • Participant must have a diagnosis of moderately-to-severely active rheumatoid arthritis (RA)
  • Participant must have had an inadequate response to, or intolerance to, at least 1 disease modifying antirheumatic drug (DMARD) (nonbiologic or biologic)
  • Participant has a negative interferon-gamma release assay (IGRA) at Screening
  • Participant has a body mass index within the range 18.0 kg/m2 to 35.0 kg/m2 (inclusive)
  • Male or female

  • A female participant is eligible to participate if:

    i) she is not pregnant, ii) not breastfeeding, iii) at least one of the following conditions applies:

    1. Not a woman of childbearing potential (WOCBP) OR

    2. A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and until the Safety Follow-up (SFU) Visit

      Exclusion Criteria:

  • Participant has a known hypersensitivity to any components of the study medication(including polyethylene glycol) or comparative drugs (and/or an investigational device) as stated in this protocol
  • Participant has clinically significant electrocardiogram (ECG) abnormalities at Screening
  • Participant has previously been exposed to certolizumab pegol (CZP)
  • Participant has failed treatment with ≥1 tumor necrosis factor (TNF) α inhibitor or was a primary failure for any TNFα antagonist. A primary failure is defined as no clinical disease improvement within the first 12 weeks of treatment (study participants who demonstrated clinical response within 12 weeks of treatment and subsequently lost response after 12 weeks of treatment are eligible)
  • Participant has received a live vaccination within 6 weeks prior to Screening or intends to have a live vaccination during the course of the study or within 3 months following CZP treatment in the study
  • Participant has received any investigational drug or experimental procedure within 90 days prior to the first dose of IMPinvestigational medicinal product (IMP)

  • Participant has a laboratory abnormality at Screening, including any of the following:

    1. >3.0x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP); or >ULN total bilirubin (>1.5x ULN total bilirubin if the participant has a documented pre-study diagnosis of Gilbert's syndrome)
    2. white blood cell count <3.00x103/μL
    3. absolute neutrophil count (ANC) <1.5x103/μL
    4. lymphocyte count <500 cells/μL
    5. hemoglobin <8.5 g/dL
    6. Any other laboratory abnormality, which, in the opinion of the Investigator, will prevent the study participant from completing the study or will interfere with the interpretation of the study results

Sites / Locations

  • Ra0138 1002
  • Ra0138 1008
  • Ra0138 1004
  • Ra0138 1005
  • Ra0138 1003
  • Ra0138 1016
  • Ra0138 1007
  • Ra0138 1010
  • Ra0138 1011

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Certolizumab pegol

Arm Description

Subjects in this arm will receive doses of certolizumab pegol for the treatment of Rheumatoid Arthritis, in accordance with the US label.

Outcomes

Primary Outcome Measures

Minimum observed plasma concentration (Cmin) after 10 weeks of certolizumab pegol dosing
Cmin: Minimum observed plasma concentration
Area under the concentration-time curve over one dosing interval (AUCtau) of certolizumab pegol
AUCtau: Area under the concentration-time curve over one dosing interval

Secondary Outcome Measures

Plasma Concentration of Certolizumab Pegol (CZP) during the study
Plasma samples will be taken at Baseline and during the study for all subjects.
Incidence of Treatment-Emergent Serious Adverse Event (SAEs)
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires in patient hospitalization or prolongation of existing hospitalization Results in persistent disability/incapacity Is a congenital anomaly or birth defect Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
Incidence of Treatment-emergent (TEAEs) leading to withdrawal
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Full Information

First Posted
February 2, 2021
Last Updated
July 26, 2022
Sponsor
UCB Biopharma SRL
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1. Study Identification

Unique Protocol Identification Number
NCT04740814
Brief Title
A Study to Assess the Pharmacokinetics of Certolizumab Pegol in Adults With Active Rheumatoid Arthritis
Official Title
A Multi-Center, Open-Label Study to Evaluate the Pharmacokinetics of Certolizumab Pegol in Adults With Active Rheumatoid Arthritis Using an Electrochemiluminescent Immuno-Assay
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 11, 2021 (Actual)
Primary Completion Date
January 24, 2022 (Actual)
Study Completion Date
June 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma SRL

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to evaluate the pharmacokinetics and safety of certolizumab pegol in adults with active rheumatoid arthritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid arthritis, Phase 1, Cimzia, Certolizumab pegol, Electrochemiluminescent immune-assay

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Certolizumab pegol
Arm Type
Experimental
Arm Description
Subjects in this arm will receive doses of certolizumab pegol for the treatment of Rheumatoid Arthritis, in accordance with the US label.
Intervention Type
Drug
Intervention Name(s)
Certolizumab pegol
Intervention Description
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous Subjects will receive certolizumab pegol in a pre-specified sequence during the study.
Primary Outcome Measure Information:
Title
Minimum observed plasma concentration (Cmin) after 10 weeks of certolizumab pegol dosing
Description
Cmin: Minimum observed plasma concentration
Time Frame
From Week 10 to Week 12
Title
Area under the concentration-time curve over one dosing interval (AUCtau) of certolizumab pegol
Description
AUCtau: Area under the concentration-time curve over one dosing interval
Time Frame
From Week 10 to Week 12
Secondary Outcome Measure Information:
Title
Plasma Concentration of Certolizumab Pegol (CZP) during the study
Description
Plasma samples will be taken at Baseline and during the study for all subjects.
Time Frame
Baseline and during Weeks 1, 2, 6, 10, 11, 12, 18 and 24
Title
Incidence of Treatment-Emergent Serious Adverse Event (SAEs)
Description
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires in patient hospitalization or prolongation of existing hospitalization Results in persistent disability/incapacity Is a congenital anomaly or birth defect Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
Time Frame
From Baseline to the the Safety Follow-up Visit (up to Week 34)
Title
Incidence of Treatment-emergent (TEAEs) leading to withdrawal
Description
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time Frame
From Baseline to the the Safety Follow-up Visit (up to Week 34)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant must be 18 to 69 years of age inclusive, at the time of signing the informed consent Participant must have a diagnosis of moderately-to-severely active rheumatoid arthritis (RA) Participant must have had an inadequate response to, or intolerance to, at least 1 disease modifying antirheumatic drug (DMARD) (nonbiologic or biologic) Participant has a negative interferon-gamma release assay (IGRA) at Screening Participant has a body mass index within the range 18.0 kg/m2 to 35.0 kg/m2 (inclusive) Male or female A female participant is eligible to participate if: i) she is not pregnant, ii) not breastfeeding, iii) at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and until the Safety Follow-up (SFU) Visit Exclusion Criteria: Participant has a known hypersensitivity to any components of the study medication(including polyethylene glycol) or comparative drugs (and/or an investigational device) as stated in this protocol Participant has clinically significant electrocardiogram (ECG) abnormalities at Screening Participant has previously been exposed to certolizumab pegol (CZP) Participant has failed treatment with ≥1 tumor necrosis factor (TNF) α inhibitor or was a primary failure for any TNFα antagonist. A primary failure is defined as no clinical disease improvement within the first 12 weeks of treatment (study participants who demonstrated clinical response within 12 weeks of treatment and subsequently lost response after 12 weeks of treatment are eligible) Participant has received a live vaccination within 6 weeks prior to Screening or intends to have a live vaccination during the course of the study or within 3 months following CZP treatment in the study Participant has received any investigational drug or experimental procedure within 90 days prior to the first dose of IMPinvestigational medicinal product (IMP) Participant has a laboratory abnormality at Screening, including any of the following: >3.0x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP); or >ULN total bilirubin (>1.5x ULN total bilirubin if the participant has a documented pre-study diagnosis of Gilbert's syndrome) white blood cell count <3.00x103/μL absolute neutrophil count (ANC) <1.5x103/μL lymphocyte count <500 cells/μL hemoglobin <8.5 g/dL Any other laboratory abnormality, which, in the opinion of the Investigator, will prevent the study participant from completing the study or will interfere with the interpretation of the study results
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Ra0138 1002
City
Covina
State/Province
California
ZIP/Postal Code
91722
Country
United States
Facility Name
Ra0138 1008
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Ra0138 1004
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Ra0138 1005
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Ra0138 1003
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Ra0138 1016
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Ra0138 1007
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Ra0138 1010
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Ra0138 1011
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

Learn more about this trial

A Study to Assess the Pharmacokinetics of Certolizumab Pegol in Adults With Active Rheumatoid Arthritis

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