A Phase 1 interventional study of Certolizumab pegol in Rheumatoid Arthritis, sponsored by UCB Biopharma SRL. Completed at 14 sites in United States. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2024-02-12.
Sponsored by UCB Biopharma SRL · Phase 1, Interventional, and Basic science
The purpose of the study is to evaluate the pharmacokinetics and safety of certolizumab pegol in adults with active rheumatoid arthritis.
3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.
This study's enrollment of 33 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →UCB Biopharma SRL is the lead sponsor of 128 studies on the registry; 19 are open to participants now.
Of its 69 completed or terminated interventional studies of FDA-regulated products, 48 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
Participant has a laboratory abnormality at Screening, including any of the following:
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.
Minimum Observed Plasma Concentration (Cmin) Post 10 Weeks of Certolizumab Pegol Dosing
Cmin is the Minimum observed plasma drug concentration during a dosage interval.
Time frame: 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.
Time frame: 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)
Plasma Concentration of Certolizumab Pegol (CZP) During the Study
Plasma samples were taken at Predose and during the study at different pre and post dose time points for all participants.
Time frame: 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)
A treatment-emergent adverse event (TEAE) was defined as events that have a start date on or following the first administration of study treatment in this study through the final administration of study treatment+70 days through Safety Follow-up (SFU) visit. 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.
Time frame: From Baseline to the Safety Follow-up Visit (up to Week 34)
Percentage of Participants With Treatment-emergent Adverse Event (TEAEs) Leading to Withdrawal
An Adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication. A TEAE was defined as events that have a start date on or following the first administration of study treatment in this study through the final administration of study treatment+70 days through Safety Follow-up (SFU) visit.
Time frame: From Baseline to the Safety Follow-up Visit (up to Week 34)
The study started to enroll participants in February 2021 and concluded in June 2022.
| Milestone | Certolizumab Pegol (All Participants) |
|---|---|
| Started | 33 |
| Completed | 23 |
| Not completed | 10 |
| Withdrew: Adverse event | 3 |
| Withdrew: Protocol violation | 2 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Withdrawal by subject | 3 |
Cmin is the Minimum observed plasma drug concentration during a dosage interval.
| micrograms per milliliter (ug/mL) | Certolizumab Pegol (All Participants) |
|---|---|
| Minimum Observed Plasma Concentration (Cmin) Post 10 Weeks of Certolizumab Pegol Dosing | 24.93 ± 44.9 |
AUCtau is the area Under the plasma concentration-time curve from time zero to tau for the dosing interval following administration at Week 10.
| hours*ug/mL | Certolizumab Pegol (All Participants) |
|---|---|
| Area Under the Concentration-time Curve Over One Dosing Interval (AUC0-tau) of Certolizumab Pegol | 11890 ± 39.6 |
Plasma samples were taken at Predose and during the study at different pre and post dose time points for all participants.
| ug/mL | Certolizumab Pegol (All Participants) |
|---|---|
| Predose (Day 0) | NA ± NA |
| Day 7 | 38.7959 ± 31.2 |
| Day 14 | 28.7381 ± 25.1 |
| Day 42 | 49.7912 ± 42.6 |
| Day 70 | 29.6138 ± 53.6 |
| Day 72 | 35.8456 ± 53.0 |
| Day 75 | 38.8787 ± 42.2 |
| Day 77 | 37.4564 ± 38.1 |
| Day 80 | 33.9728 ± 39.1 |
| Day 84 | 27.9509 ± 45.9 |
| Day 126 | 21.2735 ± 129.1 |
| Day 168 | 22.9050 ± 46.6 |
A treatment-emergent adverse event (TEAE) was defined as events that have a start date on or following the first administration of study treatment in this study through the final administration of study treatment+70 days through Safety Follow-up (SFU) visit. 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.
| percentage of participants | Certolizumab Pegol (All Participants) |
|---|---|
| Percentage of Participants With Treatment-emergent Serious Adverse Event (SAEs) | 6.1 |
An Adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication. A TEAE was defined as events that have a start date on or following the first administration of study treatment in this study through the final administration of study treatment+70 days through Safety Follow-up (SFU) visit.
| percentage of participants | Certolizumab Pegol (All Participants) |
|---|---|
| Percentage of Participants With Treatment-emergent Adverse Event (TEAEs) Leading to Withdrawal | 9.1 |
Collected over From Screening to the Safety Follow-up Visit (up to 38 Weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Certolizumab Pegol (All Participants) | 1/33 (3%) | 2/33 (6.1%) | 9/33 (27.3%) |
| Event | Certolizumab Pegol (All Participants) |
|---|---|
| Cardiac arrestCardiac disorders | 1/33 |
| Cerebrovascular accidentNervous system disorders | 1/33 |
| Event | Certolizumab Pegol (All Participants) |
|---|---|
| Upper respiratory tract infectionInfections and infestations | 3/33 |
| NauseaGastrointestinal disorders | 2/33 |
| Rheumatoid arthritisMusculoskeletal and connective tissue disorders | 2/33 |
| Urinary tract infectionInfections and infestations | 2/33 |
Baseline Characteristics refer to the Safety Set (SS) which consisted of all study participants enrolled who received greater than or equal to (≥) 1 injection of study medication.
| Age, Categorical(Participants) | Certolizumab Pegol (All Participants) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 27 |
| >=65 years | 6 |
| Age, Continuous(years) | Certolizumab Pegol (All Participants) |
|---|---|
| Mean | 55.9 ± 10.6 |
| Sex: Female, Male(Participants) | Certolizumab Pegol (All Participants) |
|---|---|
| Female | 22 |
| Male | 11 |
| Race/Ethnicity, Customized(Participants) | Certolizumab Pegol (All Participants) |
|---|---|
| Black | 7 |
| White | 25 |
| Missing | 1 |
| Race/Ethnicity, Customized(Participants) | Certolizumab Pegol (All Participants) |
|---|---|
| Hispanic or Latino | 9 |
| Not Hispanic or Latino | 24 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
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