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| ID | Type | Description | Link |
|---|---|---|---|
| Eudract no. 2007-006344-22 |
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To compare the bioavailability of a single dose of certolizumab pegol solutions given subcutaneously either by one of the three formulations and to investigate safety and tolerability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference | Active Comparator | Lyophilized formulation (reference) |
|
| Liquid | Experimental | Liquid Formulation (test) |
|
| Pre-filled Syringe | Experimental | Pre-filled syringe (test) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Certolizumab pegol | Biological | Lyophilized certolizumab pegol vial of 200mg for reconstitution of a solution with 1 mL water for injection, single dose of 400 mg given as two subcutaneous injections of 200mg |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma drug concentration-time curve from time 0 to infinity (AUC) | PK samples: from pre-dose to Week 12 | |
| Area under the plasma drug concentration-time curve from time 0 to the last quantifiable point (AUC(0-t),) | PK samples: from pre-dose to Week 12 | |
| Maximum plasma concentration (Cmax) | PK samples: from pre-dose to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Time point where log-linear elimination phase begins (TLIN ) | PK samples: from pre-dose to Week 12 | |
| Lowest quantifiable concentration time (LQCT) | PK samples: from pre-dose to Week 12 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rennes | France | |||||
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| ID | Term |
|---|---|
| D000068582 | Certolizumab Pegol |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D007140 | Immunoglobulin Fab Fragments |
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|
| Certolizumab pegol | Biological | Certolizumab pegol liquid formulation 200 mg/mL in 1 mL vial single dose of 400 mg given as two subcutaneous injections of 200mg |
|
|
| Certolizumab pegol | Biological | 200 mg/1 mL liquid certolizumab pegol solution in a pre-filled syringe, single dose of 400 mg given as two subcutaneous injections of 200mg |
|
|
| Apparent terminal elimination rate constant (λz) |
| PK samples: from pre-dose to Week 12 |
| Apparent terminal elimination half-life (t1/2) | PK samples: from pre-dose to Week 12 |
| Time corresponding to Cmax (tmax) | PK samples: from pre-dose to Week 12 |
| Apparent Total body clearance (CL/F) | PK samples: from pre-dose to Week 12 |
| Apparent Volume of distribution (Vz/F) | PK samples: from pre-dose to Week 12 |
| Extrapolated portion of the AUC (AUC_ext ) | PK samples; from pre-dose to Week 12 |
| Number of subjects with anti-certolizumab pegol antibody plasma level >2.4 units/mL | PK samples; from pre-dose to Week 12 |
| Rueil-Malmaison |
| France |
| D007128 |
| Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |