Phase 1
Completed N=224
Study to Characterize the Pharmacokinetics of a Single Dose of SC Abatacept 125 mg Using the BD Autoinjector or the Prefilled Syringe
Source: ClinicalTrials.gov NCT01890473 ↗Enrolled (actual)
224
Serious AEs
0.4%
Results posted
Nov 2015
Primary outcomePrimary: Adjusted Geometric Mean of Maximum Observed Serum Concentration (Cmax) of a Single Dose of Subcutaneous (SC) Abatacept - PK-Evaluable Analysis Population — 11.5; 12.6 μg/mL
Summary
The primary purpose of the protocol is to describe the pharmacokinetics of a single dose of Abatacept 125 mg in Rheumatoid Arthritis patients delivered via the autoinjector device or the approved prefilled syringe.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Geometric Mean of Maximum Observed Serum Concentration (Cmax) of a Single Dose of Subcutaneous (SC) Abatacept - PK-Evaluable Analysis Population |
11.5; 12.6 | — |
| PRIMARY Adjusted Geometric Mean of Area Under the Serum Concentration-time Curve (AUC) From Zero to the Last Time of the Last Quantifiable Concentration (0-T) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population |
4991; 5304 | — |
| PRIMARY Adjusted Geometric Mean of Area Under the Serum Concentration-time Curve From Time Zero to Extrapolated to Infinity, AUC (INF), of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population |
5308; 5437 | — |
| SECONDARY Median of Time to Reach Cmax in Serum (Tmax) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population |
96.0; 96.0 | — |
| SECONDARY Mean of Terminal Phase Elimination Half-life in Serum (T-HALF) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population |
285; 302 | — |
| SECONDARY Geometric Mean of Total Body Clearance (CL/F) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population |
0.31; 0.30 | — |
| SECONDARY Geometric Mean of Volume of Distribution (V/F) of a Single Dose of Subcutaneous (SC) Abatacept - PK-Evaluable Analysis Population |
0.12; 0.12 | — |
| SECONDARY Number of Participants Who Had Serious Adverse Events (SAEs), Adverse Events (AEs) That Led to Discontinuation, or Who Died |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Adverse Events of Special Interest |
19; 17; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With a Positive Immunogenicity Response Relative to Baseline |
10; 13; 4; 5; 23; 22 | — |
| SECONDARY Number of Participants With Blood Hematology, Chemistry Laboratory Values and Urinalysis Laboratory Values Meeting the Marked Abnormality Criteria |
1; 0; 0; 1; 1; 0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Subjects ≥18 years of age
- Diagnosis of Rheumatoid Arthritis confirmed by participant's physician
- Disease activity under control
Key Exclusion Criteria
- Change in disease-modifying antirheumatic drug (DMARD) therapy within 3 months of enrollment
- Exposure to investigational drug within 4 weeks or 5 half lives whichever is longer
- Current or prior use of Rituximab ≤6 months
- Current or prior use of the following within 4 weeks or 5 half lives whichever is longer: biologic DMARDS, Tofacitinib, Cyclophosphamide, Mycophenolate Mofetil & d-Penicillamine
Data sourced from ClinicalTrials.gov (NCT01890473). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.