The purpose of the study is to evaluate the pharmacokinetics and safety of certolizumab pegol in adults with active rheumatoid arthritis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
33
* Pharmaceutical form: Solution for injection * Route of administration: Subcutaneous Subjects will receive certolizumab pegol in a pre-specified sequence during the study.
Ra0138 1009
Phoenix, Arizona, United States
Ra0138 1002
Covina, California, United States
Ra0138 1008
Upland, California, United States
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)
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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
...and 4 more locations
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)