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Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After SC Administration to Subjects With RA
This study has been completed.
Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00254293
  Purpose

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


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: Abatacept or Placebo (both as IV & SC Solution)
Drug: Abatacept or Placebo (both as IV & SC solution)
 Phase I
Phase II

MedlinePlus related topics: Rheumatoid Arthritis
Drug Information available for: Abatacept
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
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)

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • This study will measure the pharmacokinetics of abatacept administered subcutaneously. PK samples are collected [ Time Frame: before and at the end of the IV dose, just prior to each SC dose, and on 4 days between doses ]

Secondary Outcome Measures:
  • Samples for anti-CTLA4Ig and anti-CTLA4 [ Time Frame: are collected every 2 weeks and at follow-up visits ]
  • Rheumatoid Factor is collected [ Time Frame: on regular intervals and at Study Discharge ]

Estimated Enrollment: 72
Study Start Date: January 2006
Study Completion Date: May 2007
Arms Assigned Interventions
Group 1 (weight < 60 kg): Placebo Comparator Drug: Abatacept or Placebo (both as IV & SC Solution)
Abatacept & Placebo as IV & SC solution, IV/SC, Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).
Group 2 (weight < 60 kg): Placebo Comparator Drug: Abatacept or Placebo (both as IV & SC Solution)
Abatacept & Placebo as IV & SC solution, IV/SC, Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).
Group 3 (weight 60-100 kg): Placebo Comparator Drug: Abatacept or Placebo (both as IV & SC solution)
Abatacept & Placebo as IV & SC solution, IV/SC, Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).
Group 4 (weight > 100 kg): Placebo Comparator Drug: Abatacept or Placebo (both as IV & SC solution)
Abatacept & Placebo as IV & SC solution, IV/SC, Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).
Group 5 (weight > 100 kg): Placebo Comparator Drug: Abatacept or Placebo (both as IV & SC solution)
Abatacept & Placebo as IV & SC solution, IV/SC, Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254293

Locations
United States, Alabama
Rheumatology Associates Of North Alabama
Huntsville, Alabama, United States, 35801
United States, California
Office Of Geoffrey S. Dolan, Md
Long Beach, California, United States, 90808
United States, Connecticut
New England Research Associates, Llc
Trumbull, Connecticut, United States, 06611
United States, Florida
Sarsota Arthritis Research Clinic
Sarsota, Florida, United States, 34239
United States, Indiana
Diagnostic Rheumatology And Research
Indianapolis, Indiana, United States, 46227
United States, Massachusetts
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States, 01610
United States, Mississippi
Arthritis And Osteoporosis Treatment And Research Center
Flowood, Mississippi, United States, 39232
United States, New Jersey
Physicians Research Center
Toms River, New Jersey, United States, 08755
United States, New York
The Center For Rheumatology
Albany, New York, United States, 12206
United States, North Carolina
Physicians East, Pa
Greenville, North Carolina, United States, 27834
Rheumatology Clinical Research
Durham, North Carolina, United States, 27704
United States, Ohio
Deaconess Arthritis Center
Cincinnati, Ohio, United States, 45219
United States, Texas
Arthritis & Osteoporosis Center Of South Texas
San Antonio, Texas, United States, 78232
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

Study ID Numbers: IM101-063
Study First Received: November 15, 2005
Last Updated: June 27, 2008
ClinicalTrials.gov Identifier: NCT00254293  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Abatacept
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
 Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:
Immunologic Factors
Immune System Diseases
Therapeutic Uses
Physiological Effects of Drugs
 Antirheumatic Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009



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