Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After SC Administration to Subjects With RA
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on October 19, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: Abatacept (Drug)
Phase: Phase 1/Phase 2
Status: Active, not recruiting
Sponsored by: Bristol-Myers Squibb
Summary
The purpose of this study is to study serum levels of Abatacept after subcutaneous dosing in subjects with RA.
Clinical Details
Official title:
A Study to Assess the Steady-State Trough Serum Concentration, Safety, and Immunogenicity of Abatacept (BMS-188667) Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis Who Are Receiving Disease Modifying Ant-Rheumatic Drugs (DMARDs)
Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Primary outcome: This study will measure the pharmacokinetics of abatacept administered subcutaneously. PK samples are collected
Secondary outcome: Samples for anti-CTLA4Ig and anti-CTLA4Rheumatoid Factor is collected
Eligibility
Minimum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Meet ARA criteria for diagnosis of RA with acitive disease.
- RA diagnosis for at least 1 year.
- > = 6 swollen joints.
- > = 8 tender joints.
- Taking MTX or MTX plus not more thatn 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 CTLA4lg, bleatacept, rituximab, efalizumab, alefacept, or other investigational drug or biologic.
- Treatment with hydroxychloroquine, azathioprine, leflunomide, immunoadsorption columns, mycophenylate mofetil, cyclosporine, D-Penicillamine or calcineurin inhibitors.
- Exposure to live vaccines.
Locations and Contacts
Rheumatology Associates Of North Alabama, Huntsville, Alabama 35801, United States
Office Of Geoffrey S. Dolan, Md, Long Beach, California 90808, United States
New England Research Associates, Llc, Trumbull, Connecticut 06611, United States
Sarsota Arthritis Research Clinic, Sarsota, Florida 34239, United States
Diagnostic Rheumatology And Research, Indianapolis, Indiana 46227, United States
Clinical Pharmacology Study Group, Worcester, Massachusetts 01610, United States
Arthritis And Osteoporosis Treatment And Research Center, Flowood, Mississippi 39232, United States
Physicians Research Center, Toms River, New Jersey 08755, United States
The Center For Rheumatology, Albany, New York 12206, United States
Physicians East, Pa, Greenville, North Carolina 27834, United States
Rheumatology Clinical Research, Durham, North Carolina 27704, United States
Deaconess Arthritis Center, Cincinnati, Ohio 45219, United States
Arthritis & Osteoporosis Center Of South Texas, San Antonio, Texas 78232, United States
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Starting date:
December 2005
Last updated: September 26, 2007
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