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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT01890473
Date of registration: 27/06/2013
Prospective Registration: Yes
Primary sponsor: Bristol-Myers Squibb
Public title: Study to Characterize the Pharmacokinetics of a Single Dose of SC Abatacept 125 mg Using the BD Autoinjector or the Prefilled Syringe
Scientific 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 Physiojectâ„¢ Autoinjector or the UltraSafe Passive Needle Guard Prefilled Syringe
Date of first enrolment: July 2013
Target sample size: 356
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01890473
Study type:  Interventional
Study design:   
Phase:  Phase 1
Countries of recruitment
Argentina Mexico Peru South Africa United States
Contacts
Name:     Bristol-Myers Squibb
Address: 
Telephone:
Email:
Affiliation:  Bristol-Myers Squibb
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Abatacept
Primary Outcome(s)
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 [Time Frame: Day 1 to Day 71]
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 [Time Frame: Day 1 to Day 71]
Adjusted Geometric Mean of Maximum Observed Serum Concentration (Cmax) of a Single Dose of Subcutaneous (SC) Abatacept - PK-Evaluable Analysis Population [Time Frame: Day 1 to Day 71]
Secondary Outcome(s)
Geometric Mean of Total Body Clearance (CL/F) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population [Time Frame: Day 1 to Day 71]
Geometric Mean of Volume of Distribution (V/F) of a Single Dose of Subcutaneous (SC) Abatacept - PK-Evaluable Analysis Population [Time Frame: Day 1 to Day 71]
Mean of Terminal Phase Elimination Half-life in Serum (T-HALF) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population [Time Frame: Day 1 to Day 71]
Median of Time to Reach Cmax in Serum (Tmax) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population [Time Frame: Day 1 to Day 71]
Number of Participants Who Had Serious Adverse Events (SAEs), Adverse Events (AEs) That Led to Discontinuation, or Who Died [Time Frame: Day 1 to 76 days post single dose]
Number of Participants With a Positive Immunogenicity Response Relative to Baseline [Time Frame: Day 57, Day 71]
Number of Participants With Adverse Events of Special Interest [Time Frame: Day 1 to 76 days post single dose]
Number of Participants With Blood Hematology, Chemistry Laboratory Values and Urinalysis Laboratory Values Meeting the Marked Abnormality Criteria [Time Frame: Day 1 to 76 days post last dose]
Secondary ID(s)
IM101-366
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 26/11/2015
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01890473
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