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)
18 Years
N/A
Both
Rheumatoid Arthritis
Trial Information
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)
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Assess the steady-state trough serum concentration of abatacept following weekly SC dosing in subjects with active RA
Outcome Time Frame:
before and at the end of the IV dose, just prior to each SC dose, and on 4 days between doses
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
IM101-063
NCT ID:
NCT00254293
Start Date:
January 2006
Completion Date:
July 2012
Related Keywords:
- Rheumatoid Arthritis
- Arthritis
- Arthritis, Rheumatoid
Name | Location |
|---|---|
| Winship Cancer Institute, Emory University | Atlanta, Georgia 30322 |
| New England Research Associates, Llc | Trumbull, Connecticut 06611 |
| Physicians East, Pa | Greenville, North Carolina 27834 |
| Rheumatology Associates Of North Alabama, P.C. | Huntsville, Alabama 35801 |
| Office Of Geoffrey S. Dolan, Md | Long Beach, California 90808 |
| Sarsota Arthritis Research Clinic | Sarsota, Florida 34239 |
| Diagnostic Rheumatology And Research, Pc | Indianapolis, Indiana 46227 |
| Clinical Pharmacology Study Group | Worcester, Massachusetts 01610 |
| Arthritis And Osteoporosis Treatment And Research Center | Flowood, Mississippi 39232 |
| Physicians Research Center, Llc | Toms River, New Jersey 08755 |
| The Center For Rheumatology, Llp | Albany, New York 12206 |
| Rheumatology Clinical Research | Durham, North Carolina 27704 |
| Deaconess Arthritis Center | Cincinnati, Ohio 45219 |
| Arthritis & Osteoporosis Center Of South Texas | San Antonio, Texas 78232 |
