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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)


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Rheumatoid Arthritis

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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 UniversityAtlanta, Georgia  30322
New England Research Associates, LlcTrumbull, Connecticut  06611
Physicians East, PaGreenville, North Carolina  27834
Rheumatology Associates Of North Alabama, P.C.Huntsville, Alabama  35801
Office Of Geoffrey S. Dolan, MdLong Beach, California  90808
Sarsota Arthritis Research ClinicSarsota, Florida  34239
Diagnostic Rheumatology And Research, PcIndianapolis, Indiana  46227
Clinical Pharmacology Study GroupWorcester, Massachusetts  01610
Arthritis And Osteoporosis Treatment And Research CenterFlowood, Mississippi  39232
Physicians Research Center, LlcToms River, New Jersey  08755
The Center For Rheumatology, LlpAlbany, New York  12206
Rheumatology Clinical ResearchDurham, North Carolina  27704
Deaconess Arthritis CenterCincinnati, Ohio  45219
Arthritis & Osteoporosis Center Of South TexasSan Antonio, Texas  78232