Clinical trial NCT04740814: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Phase 1
Cimzia
Certolizumab pegol
Electrochemiluminescent immune-assay
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2021-02-05
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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


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:
  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

Primary outcomes:
measure: Minimum Observed Plasma Concentration (Cmin) Post 10 Weeks of Certolizumab Pegol Dosing
timeFrame: Plasma samples were collected at Pre dose on Day 70 (Week 10), 72, 75, 77 and 80 post-Week 10 study Investigational Medicinal Product (IMP) administration, and Pre dose on Day 84 (Week 12)
measure: Area Under the Concentration-time Curve Over One Dosing Interval (AUC0-tau) of Certolizumab Pegol
timeFrame: Plasma samples were collected at Pre dose on Day 70 (Week 10), 72, 75, 77 and 80 post-Week 10 study IMP administration, and Pre dose on Day 84 (Week 12)
Secondary outcomes:
measure: Plasma Concentration of Certolizumab Pegol (CZP) During the Study
timeFrame: Predose (Day 0), Day 7, 14, 42, 70, 72, 75, 77, 80, 84, 126, and 168
measure: Percentage of Participants With Treatment-emergent Serious Adverse Event (SAEs)
timeFrame: From Baseline to the Safety Follow-up Visit (up to Week 34)
measure: Percentage of Participants With Treatment-emergent Adverse Event (TEAEs) Leading to Withdrawal
timeFrame: From Baseline to the Safety Follow-up Visit (up to Week 34)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Ra0138 1009
state: Arizona
city: Covina
country: United States
facility: Ra0138 1002
state: California
city: Upland
country: United States
facility: Ra0138 1008
state: California
city: Palm Harbor
country: United States
facility: Ra0138 1015
state: Florida
city: Plantation
country: United States
facility: Ra0138 1004
state: Florida
city: Lexington
country: United States
facility: Ra0138 1001
state: Kentucky
city: Rockville
country: United States
facility: Ra0138 1014
state: Maryland
city: Albuquerque
country: United States
facility: Ra0138 1005
state: New Mexico
city: Duncansville
country: United States
facility: Ra0138 10025
state: Pennsylvania
city: Duncansville
country: United States
facility: Ra0138 1003
state: Pennsylvania
city: Memphis
country: United States
facility: Ra0138 1016
state: Tennessee
city: Austin
country: United States
facility: Ra0138 1007
state: Texas
city: Dallas
country: United States
facility: Ra0138 1010
state: Texas
city: Tomball
country: United States
facility: Ra0138 1011
state: Texas
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: