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A Study to Assess the Pharmacokinetics of Certolizumab Pegol in Adults With Active Rheumatoid Arthritis | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Multi-Center, Open-Label Study to Evaluate the Pharmacokinetics of Certolizumab Pegol in Adults With Active Rheumatoid Arthritis Using an Electrochemiluminescent Immuno-Assay

NCT04740814•UCB Biopharma SRL

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 69 years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

Locations (14)

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

Key Dates

Start Date

February 11, 2021

Primary Completion Date

January 24, 2022

Completion Date

June 27, 2022

Last Updated

February 12, 2024

Enrollment

ACTUAL participants

Conditions

Rheumatoid Arthritis

Interventions

Certolizumab pegol

DRUG

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

NCT07484243

Rheumatoid Arthritis (RA)Rheumatoid Arthritis-Associated Interstitial Lung Disease+1 more

View study

RECRUITINGPHASE1

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

NCT06647069

Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

Targeted Remotely-delivered Anti-inflammatory Interventions With Exercise for Rheumatoid Arthritis

Plant-Based Diet for Patients With Rheumatoid Arthritis

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An Ascending Dose Study of PIT565 in Participants With Rheumatoid Arthritis