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

NCT ID: NCT04740814

Last Updated: 2024-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-11
• Study Completion Date: 2022-06-27

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Certolizumab pegol

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

Group Type: EXPERIMENTAL

Certolizumab pegol

Intervention Type: DRUG

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

Interventions

Certolizumab pegol

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Biopharma SRL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273 (UCB)

Locations

Ra0138 1009

Phoenix, Arizona, United States

Ra0138 1002

Covina, California, United States

Ra0138 1008

Upland, California, United States

Ra0138 1015

Palm Harbor, Florida, United States

Ra0138 1004

Plantation, Florida, United States

Ra0138 1001

Lexington, Kentucky, United States

Ra0138 1014

Rockville, Maryland, United States

Ra0138 1005

Albuquerque, New Mexico, United States

Ra0138 10025

Duncansville, Pennsylvania, United States

Ra0138 1003

Duncansville, Pennsylvania, United States

Ra0138 1016

Memphis, Tennessee, United States

Ra0138 1007

Austin, Texas, United States

Ra0138 1010

Dallas, Texas, United States

Ra0138 1011

Tomball, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

RA0138

Identifier Type: -

Identifier Source: org_study_id