Phase 2 Completed N=68 Randomized Double-blind Treatment

Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After Subcutaneous (SC) Administration to Subjects With Rheumatoid Arthritis (RA)

Source: ClinicalTrials.gov NCT00254293 ↗

Enrolled (actual)

Serious AEs

29.0%

Results posted

Apr 2014

Primary outcomePrimary: Short Term Period: Steady-state Trough Serum Concentration (Cmin) of Abatacept Following Weekly Subcutaneous Dosing in Participants With Active Rheumatoid Arthritis Receiving Disease Modifying Anti-rheumatic Drugs (DMARDS) — 22.64; 28.03; 24.05; 16.22 µg/mL

Summary

The purpose of this study is to study serum levels of Abatacept after subcutaneous dosing in subjects with RA.

Outcome Measures

Outcome	Result	p-value
PRIMARY Short Term Period: Steady-state Trough Serum Concentration (Cmin) of Abatacept Following Weekly Subcutaneous Dosing in Participants With Active Rheumatoid Arthritis Receiving Disease Modifying Anti-rheumatic Drugs (DMARDS)	22.64; 28.03; 24.05; 16.22; 26.52; 21.66	—
PRIMARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Reported During the Variable Dosing Phase of the Long Term Period (LTE)	0; 1; 0; 2; 13; 4	—
PRIMARY Number of Participants With Pre-specified AEs of Special Interest in the Variable Dosing Phase of Long Term Extension (LTE)	1; 1; 2; 1; 5; 1	—
PRIMARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Summarized Over the Entire Long Term Extension (LTE) Period (Both Variable and Fixed Dosing)	6; 35; 7; 3; 61; 34	—
SECONDARY Short Term Period: Peak Serum Concentration (Cmax) of Abatacept at Steady State in Participants With Rheumatoid Arthritis Receiving DMARDS	26.3; 34.9; 31.9; 14.7; 41.7	—
SECONDARY Short Term Period: Area Under the Curve (AUC) in Time Interval of 7 Days [AUC(TAU)] of Abatacept in Participants With Rheumatoid Arthritis Receiving DMARDS	4066; 6699; 4607; 2555; 5849	—
SECONDARY Short Term Period: Summary of Adverse Events (AEs), Serious AEs, Deaths, and Discontinuations Due to AEs During 12 Weeks of Treatment With Either Abatacept or Placebo	0; 0; 0; 0; 0; 0	—
SECONDARY Short Term Period: Number of Participants With Pre-specified Adverse Events (AEs) of Special Interest After Administration of Abatacept or Placebo Over 12 Weeks	3; 1; 9; 3; 1; 4	—
SECONDARY Short Term Period: Mean Percent Change From Baseline on Day 85 in Participants Positive for Serum Rheumatoid Factor During Abatacept or Placebo Administration	-1.50; -8.89; -17.69; -16.29; -19.32; 43.72	—
SECONDARY Short Term Period: Number of Participants With Laboratory Abnormalities in Hematology at Baseline (Day 1) to End of Period (Day 85)	4; 3; 15; 1; 2; 9	—
SECONDARY Short Term Period: Number of Participants With Laboratory Abnormalities in Serum Chemistry at Baseline and on Treatment up to Day 85	2; 2; 6; 1; 4; 7	—
SECONDARY Short Term Period: Mean Change From Baseline at Day 85 in Blood Pressure After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS	-5.2; 0.0; 0.7; 3.5; -5.4; 1.8	—
SECONDARY Short Term Period: Mean Change From Baseline at Day 85 in Pulse Rate After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS	-2.9; 0.3; -0.6; 3.5; -11.4; -1.0	—
SECONDARY Short Term Period: Mean Change From Screening to Day 85 in Electrocardiogram (QT, PR Intervals, QRS Width) After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS	-1.47; 5.28; 0.22	—
SECONDARY Short Term Period: Mean Change From Screening at Day 85 in ECG (Heart Rate) After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS	0.51	—
SECONDARY Overall Study ST and LTE Periods: Number of Participants With Anti-abatacept Antibodies and/or Anti-cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibodies	0; 0; 0; 1; 0; 11	—

Eligibility Criteria

Inclusion Criteria

Meet ARA criteria for diagnosis of RA with active disease.
RA diagnosis for at least 1 year.
> = 6 swollen joints.
> = 8 tender joints.
Taking methotrexate (MTX) or MTX plus not more than 1 added oral DMARD for > = 3 months and stable for 28 days prior to dosing.

Exclusion Criteria

Serious acute or bacterial infection in last 3 months.
Chronic or recurrent bacterial infections.
History of TB within previous 3 years or old TB not adequately treated.
Specific lab test abnormalities
History of cancer within 5 years.
Exposure to CTLA4Ig (Cytotoxic T-lymphocyte (T-cell)-associated antigen 4Ig), belatacept, rituximab, efalizumab, alefacept, or other investigational drug or biologic.
Treatment with hydroxychloroquine, azathioprine, leflunomide, immunoadsorption columns, mycophenolate mofetil, cyclosporine, D-Penicillamine or calcineurin inhibitors.
Exposure to live vaccines.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00254293). 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.