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

• Sponsor: UCB Biopharma SRL (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04740814
• Collaborator: (none)
• Enrollment: 33
• Locations: 9
• Arm: 1
• Actual Duration (Months): 16.5
• Patients Per Site: 3.7
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Certolizumab pegol	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Multi-Center, Open-Label Study to Evaluate the Pharmacokinetics of Certolizumab Pegol in Adults With Active Rheumatoid Arthritis Using an Electrochemiluminescent Immuno-Assay
• Actual Study Start Date: Feb 11, 2021
• Actual Primary Completion Date: Jan 24, 2022
• Actual Study Completion Date: Jun 27, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	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.

Outcome Measures

Primary Outcome Measures

1. Minimum observed plasma concentration (Cmin) after 10 weeks of certolizumab pegol dosing [From Week 10 to Week 12]

   Cmin: Minimum observed plasma concentration

2. Area under the concentration-time curve over one dosing interval (AUCtau) of certolizumab pegol [From Week 10 to Week 12]

   AUCtau: Area under the concentration-time curve over one dosing interval

Secondary Outcome Measures

1. Plasma Concentration of Certolizumab Pegol (CZP) during the study [Baseline and during Weeks 1, 2, 6, 10, 11, 12, 18 and 24]

   Plasma samples will be taken at Baseline and during the study for all subjects.

2. Incidence of Treatment-Emergent Serious Adverse Event (SAEs) [From Baseline to the the Safety Follow-up Visit (up to Week 34)]

   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

3. Incidence of Treatment-emergent (TEAEs) leading to withdrawal [From Baseline to the the Safety Follow-up Visit (up to Week 34)]

   An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ra0138 1002	Covina	California	United States	91722
2	Ra0138 1008	Upland	California	United States	91786
3	Ra0138 1004	Plantation	Florida	United States	33324
4	Ra0138 1005	Albuquerque	New Mexico	United States	87102
5	Ra0138 1003	Duncansville	Pennsylvania	United States	16635
6	Ra0138 1016	Memphis	Tennessee	United States	38119
7	Ra0138 1007	Austin	Texas	United States	78731
8	Ra0138 1010	Dallas	Texas	United States	75231
9	Ra0138 1011	Tomball	Texas	United States	77375

Sponsors and Collaborators

• UCB Biopharma SRL

Investigators

• Study Director: UCB Cares, 001 844 599 2273 (UCB)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: UCB Biopharma SRL
• ClinicalTrials.gov Identifier: NCT04740814
• Other Study ID Numbers: RA0138
• First Posted: Feb 5, 2021
• Last Update Posted: Jul 27, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by UCB Biopharma SRL: Rheumatoid arthritis; Phase 1; Cimzia; Certolizumab pegol; Electrochemiluminescent immune-assay
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Certolizumab Pegol

Study Results

No Results Posted as of Jul 27, 2022