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History of Changes for Study: NCT04740814
A Study to Assess the Pharmacokinetics of Certolizumab Pegol in Adults With Active Rheumatoid Arthritis
Latest version (submitted February 9, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 2, 2021 None (earliest Version on record)
2 March 5, 2021 Study Status
3 March 29, 2021 Recruitment Status, Study Status and Contacts/Locations
4 April 1, 2021 Contacts/Locations and Study Status
5 May 27, 2021 Contacts/Locations and Study Status
6 June 11, 2021 Study Status and Contacts/Locations
7 June 24, 2021 Contacts/Locations and Study Status
8 January 20, 2022 Study Status and Contacts/Locations
9 February 11, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
10 February 17, 2022 Study Status
11 March 3, 2022 Study Status
12 March 17, 2022 Study Status
13 May 18, 2022 Study Status
14 May 26, 2022 Study Status
15 June 23, 2022 Study Status
16 July 7, 2022 Study Status
17 July 26, 2022 Recruitment Status and Study Status
18 January 24, 2023 Outcome Measures, Study Status, Document Section, Results, References and Contacts/Locations
19 February 9, 2024 Study Status
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Study NCT04740814
Submitted Date:  February 2, 2021 (v1)
Open or close this module Study Identification
Unique Protocol ID: RA0138
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
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2021
Overall Status: Not yet recruiting
Study Start: February 2021
Primary Completion: July 2022 [Anticipated]
Study Completion: July 2022 [Anticipated]
First Submitted: February 2, 2021
First Submitted that
Met QC Criteria:		 February 2, 2021
First Posted: February 5, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:		 February 2, 2021
Last Update Posted: February 5, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: UCB Biopharma SRL
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Phase 1
Cimzia
Certolizumab pegol
Electrochemiluminescent immune-assay
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 30 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Certolizumab pegol
Subjects in this arm will receive doses of certolizumab pegol for the treatment of Rheumatoid Arthritis, in accordance with the US label.
 Drug: Certolizumab pegol
  • Pharmaceutical form: Solution for injection
  • Route of administration: Subcutaneous Subjects will receive certolizumab pegol in a pre-specified sequence during the study.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Minimum observed plasma concentration (Cmin) after 10 weeks of certolizumab pegol dosing
[ Time Frame: From Week 10 to Week 12 ]

Cmin: Minimum observed plasma concentration
2. Area under the concentration-time curve over one dosing interval (AUCtau) of certolizumab pegol
[ Time Frame: From Week 10 to Week 12 ]

AUCtau: Area under the concentration-time curve over one dosing interval
Secondary Outcome Measures:
1. Plasma Concentration of Certolizumab Pegol (CZP) during the study
[ Time Frame: Baseline and during Weeks 1, 2, 6, 10, 11, 12, 18 and 24 ]

Plasma samples will be taken at Baseline and during the study for all subjects.
2. Incidence of Treatment-Emergent Serious Adverse Event (SAEs)
[ Time Frame: From Baseline to the the Safety Follow-up Visit (up to Week 34) ]

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
3. Incidence of Treatment-emergent (TEAEs) leading to withdrawal
[ Time Frame: From Baseline to the the Safety Follow-up Visit (up to Week 34) ]

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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 69 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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:

    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
Open or close this module Contacts/Locations
Central Contact Person: UCB Cares
Telephone: +1844599 Ext. 2273
Email: UCBCares@ucb.com
Study Officials: UCB Cares
Study Director
001 844 599 2273 (UCB)
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
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.
Open or close this module References
Citations:
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services