Phase 3 N=120 Treatment

Methotrexate-Inadequate Response Autoinjector Device Sub Study

Rheumatoid Arthritis

Bottom Line

View on ClinicalTrials.gov: NCT01844895 ↗

Enrolled (actual)

120

Serious AEs

2.6%

Results posted

Jul 2015

Primary outcome: Primary: Pharmacokinetic (PK) Analysis: Adjusted Geometric Mean Observed Serum Trough Concentration at Steady State (Cminss) of Abatacept Using a Prefilled Syringe (Measured on Day 29) and Using an Autoinjector (Measured on Day 113) — 27.76; 25.32 μg/mL

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Abatacept (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: Jul 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Pharmacokinetic (PK) Analysis: Adjusted Geometric Mean Observed Serum Trough Concentration at Steady State (Cminss) of Abatacept Using a Prefilled Syringe (Measured on Day 29) and Using an Autoinjector (Measured on Day 113)	27.76; 25.32	—
SECONDARY PK Analysis: Geometric Mean of Maximum Observed Serum Concentration (Cmax) of Abatacept During the Sampling Period Between Substudy Days 22 and 29 for the Prefilled Syringe and Between Substudy Days 106 and Day 113 for the Autoinjector	40.9; 39.8	—
SECONDARY PK Analysis: Median Time to Achieve Cmax (Tmax) During the Sampling Period Between Days 22 and 29 for the Prefilled Syringe and Between Days 106 and Day 113 for the Autoinjector	70.00; 56.34	—
SECONDARY Geometric Mean of Area Under Serum Concentration-time (AUC) During a Dosing Interval (TAU) of Abatacept During the Sampling Period Between Days 22 and 29 for the Prefilled Syringe and Between Days 106 and Day 113 for the Autoinjector	5740; 5643	—
SECONDARY Geometric Mean of Trough Serum Concentration (Cmin) Over Time and During the Switch From Prefilled Syringe to Autoinjector on Days 22, 29, 57, 85, 106, and 113	29.09; NA; 30.58; NA; NA; 28.79	—
SECONDARY Number of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by Electrochemiluminescence (ECL) on Day 29 and Day 113.	1; 1; 5; 2	—

Summary

The purpose of this study is to implement a substudy in approximately 120 rheumatoid arthritis (RA) subjects to compare the steady-state serum trough concentration (Cminss), Cmax and area under the curve (AUC) during the dosing interval (TAU) of subcutaneous (SC) Abatacept injection of 125 mg via the autoinjector and via the BD Hypak™ Physiolis prefilled syringe.

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria

Subjects who have been treated in the long term (LT) with open-label SC Abatacept for at least 3 months
Must continue to meet inclusion criteria specified in main IM101-174 Study Protocol

Exclusion Criteria

Participation in previous device substudy (implemented by Amendment 10)
Must continue to meet exclusion criteria specified in main IM101-174 Study Protocol

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01844895). 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.