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

NCT04740814 | Completed Phase 1 Results FDA Drug

• 1 other identifier: RA0138
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 14

Brief Summary

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

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis; Phase 1; Cimzia; Certolizumab pegol; Electrochemiluminescent immune-assay

Outcome Measures

Primary Outcomes (2)

• Minimum Observed Plasma Concentration (Cmin) Post 10 Weeks of Certolizumab Pegol Dosing

  Cmin is the Minimum observed plasma drug concentration during a dosage interval.

  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)

• Area Under the Concentration-time Curve Over One Dosing Interval (AUC0-tau) of Certolizumab Pegol

  AUCtau is the area Under the plasma concentration-time curve from time zero to tau for the dosing interval following administration at Week 10.

  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 (3)

• 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

• Percentage of Participants With Treatment-emergent Serious Adverse Event (SAEs)

  From Baseline to the Safety Follow-up Visit (up to Week 34)

• Percentage of Participants With Treatment-emergent Adverse Event (TEAEs) Leading to Withdrawal

  From Baseline to the Safety Follow-up Visit (up to Week 34)

Study Arms (1)

Certolizumab pegol

EXPERIMENTAL

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

Interventions

Certolizumab pegol DRUG

* Pharmaceutical form: Solution for injection * Route of administration: Subcutaneous Subjects will receive certolizumab pegol in a pre-specified sequence during the study.

Certolizumab pegol

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (14)

Ra0138 1009

Phoenix, Arizona, 85032, United States

Location

Ra0138 1002

Covina, California, 91722, United States

Location

Ra0138 1008

Upland, California, 91786, United States

Location

Ra0138 1015

Palm Harbor, Florida, 34684, United States

Location

Ra0138 1004

Plantation, Florida, 33324, United States

Location

Ra0138 1001

Lexington, Kentucky, 40504, United States

Location

Ra0138 1014

Rockville, Maryland, 20850, United States

Location

Ra0138 1005

Albuquerque, New Mexico, 87102, United States

Location

Ra0138 10025

Duncansville, Pennsylvania, 16635, United States

Location

Ra0138 1003

Duncansville, Pennsylvania, 16635, United States

Location

Ra0138 1016

Memphis, Tennessee, 38119, United States

Location

Ra0138 1007

Austin, Texas, 78731, United States

Location

Ra0138 1010

Dallas, Texas, 75231, United States

Location

Ra0138 1011

Tomball, Texas, 77375, United States

Location

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 5, 2021
• Study Start: February 11, 2021
• Primary Completion: January 24, 2022
• Study Completion: June 27, 2022
• Last Updated: February 12, 2024
• Results First Posted: November 13, 2023

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)