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

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)

Population: The PKS included the study participants who had provided plasma samples with measurable concentrations (with recorded sampling time) on at least 1 visit, and who had no important protocol deviations affecting the PK parameters. Here, Number of participants analyzed included those participants who were evaluable for the assessment.

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)

Population: The Pharmacokinetic Set (PKS) included the study participants who had provided plasma samples with measurable concentrations (with recorded sampling time) on at least 1 visit, and who had no important protocol deviations affecting the PK parameters. Here, Number of participants analyzed included those participants who were evaluable for the assessment.

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)

Population: The SS included all study participants enrolled who received ≥1 injection of study medication.

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)

Population: The SS included all study participants enrolled who received ≥1 injection of study medication.

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

Population: The PKS included the study participants who had provided plasma samples with measurable concentrations (with recorded sampling time) on at least 1 visit, and who had no important protocol deviations affecting the PK parameters. Here, Number of participants analyzed included those participants who were evaluable for the assessment and 'n' (Number analyzed) signifies participants who were evaluable at specified time points.