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

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Certolizumab pegol

• Registration Number: NCT04740814
• Lead Sponsor: UCB Biopharma SRL

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

Not available

Study Timeline

• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-05
• Study Start: 2021-02-11
• Primary Completion: 2022-01-24
• Study Completion: 2022-06-27
• Results First Submitted: 2023-01-24
• Results First Submitted QC: 2023-01-24
• Results First Posted: 2023-11-13
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Minimum Observed Plasma Concentration (Cmin) Post 10 Weeks of Certolizumab Pegol Dosing	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)	Cmin is the Minimum observed plasma drug concentration during a dosage interval.
Area Under the Concentration-time Curve Over One Dosing Interval (AUC0-tau) of Certolizumab Pegol	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)	AUCtau is the area Under the plasma concentration-time curve from time zero to tau for the dosing interval following administration at Week 10.

Secondary Outcome Measures

Name	Time	Method
Plasma Concentration of Certolizumab Pegol (CZP) During the Study	Predose (Day 0), Day 7, 14, 42, 70, 72, 75, 77, 80, 84, 126, and 168	Plasma samples were taken at Predose and during the study at different pre and post dose time points for all participants.
Percentage of Participants With Treatment-emergent Serious Adverse Event (SAEs)	From Baseline to the Safety Follow-up Visit (up to Week 34)	A treatment-emergent adverse event (TEAE) was defined as events that have a start date on or following the first administration of study treatment in this study through the final administration of study treatment+70 days through Safety Follow-up (SFU) visit. 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.
Percentage of Participants With Treatment-emergent Adverse Event (TEAEs) Leading to Withdrawal	From Baseline to the Safety Follow-up Visit (up to Week 34)	An Adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication. A TEAE was defined as events that have a start date on or following the first administration of study treatment in this study through the final administration of study treatment+70 days through Safety Follow-up (SFU) visit.

Trial Locations

Locations (14)

Ra0138 10025; 🇺🇸 Duncansville, Pennsylvania, United States

Ra0138 1016; 🇺🇸 Memphis, Tennessee, United States

Ra0138 1002; 🇺🇸 Covina, California, United States

Ra0138 1005; 🇺🇸 Albuquerque, New Mexico, United States

Ra0138 1009; 🇺🇸 Phoenix, Arizona, United States

Ra0138 1015; 🇺🇸 Palm Harbor, Florida, United States

Ra0138 1001; 🇺🇸 Lexington, Kentucky, United States

Ra0138 1008; 🇺🇸 Upland, California, United States

Ra0138 1014; 🇺🇸 Rockville, Maryland, United States

Ra0138 1003; 🇺🇸 Duncansville, Pennsylvania, United States

Ra0138 1010; 🇺🇸 Dallas, Texas, United States

Ra0138 1011; 🇺🇸 Tomball, Texas, United States

Ra0138 1004; 🇺🇸 Plantation, Florida, United States

Ra0138 1007; 🇺🇸 Austin, Texas, United States