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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 69 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04740814
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

UCB Biopharma SRL
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

UCB Cares
Principal Investigator Affiliation 001 844 599 2273 (UCB)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis
Arms & Interventions

Arms

Experimental: Certolizumab pegol

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

Interventions

Drug: - Certolizumab pegol

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Ra0138 1009, Phoenix, Arizona

Status

Recruiting

Address

Ra0138 1009

Phoenix, Arizona, 85032

Ra0138 1002, Covina, California

Status

Recruiting

Address

Ra0138 1002

Covina, California, 91722

Ra0138 1015, Palm Harbor, Florida

Status

Recruiting

Address

Ra0138 1015

Palm Harbor, Florida, 34684

Ra0138 1004, Plantation, Florida

Status

Recruiting

Address

Ra0138 1004

Plantation, Florida, 33324

Ra0138 1001, Lexington, Kentucky

Status

Recruiting

Address

Ra0138 1001

Lexington, Kentucky, 40504

Ra0138 1003, Duncansville, Pennsylvania

Status

Recruiting

Address

Ra0138 1003

Duncansville, Pennsylvania, 16635

Ra0138 1016, Memphis, Tennessee

Status

Recruiting

Address

Ra0138 1016

Memphis, Tennessee, 38119

Ra0138 1007, Austin, Texas

Status

Recruiting

Address

Ra0138 1007

Austin, Texas, 78731

Ra0138 1010, Dallas, Texas

Status

Recruiting

Address

Ra0138 1010

Dallas, Texas, 75231