Clinical trial NCT01890473: Study to Characterize the Pharmacokinetics of a Single Dose of SC Abatacept 125 mg Using the BD Autoinjector or the Prefilled Syringe
Official title: Phase Ib, Multicenter, Randomized, Open-Label, Parallel-Group Study to Characterize the Pharmacokinetics of a Single Dose of Abatacept 125 mg Administered Subcutaneously Using the BD Physioject™ Autoinjector or the UltraSafe Passive Needle Guard Prefilled Syringe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2013-07-01
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: SC=Subcutaneous

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

Primary outcomes:
measure: Adjusted Geometric Mean of Maximum Observed Serum Concentration (Cmax) of a Single Dose of Subcutaneous (SC) Abatacept - PK-Evaluable Analysis Population
timeFrame: Day 1 to Day 71
measure: 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
timeFrame: Day 1 to Day 71
measure: 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
timeFrame: Day 1 to Day 71
Secondary outcomes:
measure: Median of Time to Reach Cmax in Serum (Tmax) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population
timeFrame: Day 1 to Day 71
measure: Mean of Terminal Phase Elimination Half-life in Serum (T-HALF) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population
timeFrame: Day 1 to Day 71
measure: Geometric Mean of Total Body Clearance (CL/F) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population
timeFrame: Day 1 to Day 71
measure: Geometric Mean of Volume of Distribution (V/F) of a Single Dose of Subcutaneous (SC) Abatacept - PK-Evaluable Analysis Population
timeFrame: Day 1 to Day 71
measure: Number of Participants Who Had Serious Adverse Events (SAEs), Adverse Events (AEs) That Led to Discontinuation, or Who Died
timeFrame: Day 1 to 76 days post single dose
measure: Number of Participants With Adverse Events of Special Interest
timeFrame: Day 1 to 76 days post single dose
measure: Number of Participants With a Positive Immunogenicity Response Relative to Baseline
timeFrame: Day 57, Day 71
measure: Number of Participants With Blood Hematology, Chemistry Laboratory Values and Urinalysis Laboratory Values Meeting the Marked Abnormality Criteria
timeFrame: Day 1 to 76 days post last dose
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Rheumatology Associates Of North Alabama, P.C.
state: Alabama
city: Centennial
country: United States
facility: Immunoe Int'L Research Ctrs
state: Colorado
city: Daytona Beach
country: United States
facility: Covance Cru Inc
state: Florida
city: Wichita
country: United States
facility: Heartland Research Associates, Llc
state: Kansas
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Lincoln
country: United States
facility: Physician Research Collaboration, Llc
state: Nebraska
city: Charlotte
country: United States
facility: Djl Research, Pllc
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Salisbury
country: United States
facility: Pmg Research Of Salisbury
state: North Carolina
city: Wilmington
country: United States
facility: Pmg Research Of Wilmington Llc
state: North Carolina
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Dallas
country: United States
facility: Covance Clinical Research Unit Inc.
state: Texas
city: San Fernando
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Rosario
country: Argentina
facility: Local Institution
state: Santa Fe
city: San Miguel De Tucuman
country: Argentina
facility: Local Institution
state: Tucuman
city: Cordoba
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Yucatan
country: Mexico
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Port Elizabeth
country: South Africa
facility: Local Institution
state: Eastern Cape
city: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: George
country: South Africa
facility: Local Institution
state: Western Cape
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: