Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After SC Administration to Subjects With RA - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by (Responsible Party):	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) Drug: Abatacept	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Abatacept

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Assess the steady-state trough serum concentration of abatacept following weekly SC dosing in subjects with active RA [ Time Frame: before and at the end of the IV dose, just prior to each SC dose, and on 4 days between doses ] [ Designated as safety issue: Yes ]
The primary objective of the open-label period is to assess the safety, immunogenicity and long term tolerability of subcutaneous administration of abatacept in subjects who have completed the initial 12-week treatment with abatacept [ Time Frame: safety monitoring every 4 weeks; immunogenicity every 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess the safety and tolerability of abatacept administered SC in RA subjects [ Time Frame: are collected every 2 weeks and at follow-up visits - short term ] [ Designated as safety issue: Yes ]
To assess the immunogenicity of abatacept administered SC in RA subjects [ Time Frame: are collected every 2 weeks and at follow-up visits - short term ] [ Designated as safety issue: Yes ]
To examine the effect of SC administered abatacept on serum levels of RF in RA subjects [ Time Frame: on regular intervals and at Study Discharge - short term ] [ Designated as safety issue: No ]

Estimated Enrollment:	72
Study Start Date:	January 2006
Estimated Study Completion Date:	July 2012
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Group 1 (weight < 60 kg)	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). Other Name: Orencia
Placebo Comparator: Group 2 (weight < 60 kg)	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). Other Name: Orencia
Placebo Comparator: Group 3 (weight 60-100 kg)	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). Other Name: Orencia
Placebo Comparator: Group 4 (weight > 100 kg)	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). Other Name: Orencia
Placebo Comparator: Group 5 (weight > 100 kg)	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). Other Name: Orencia
Experimental: Abatacept Long Term	Drug: Abatacept Solution in pre-filled syringes, Subcutaneously, 125 mg, Weekly

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, P.C.
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, Georgia
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
United States, Indiana
Diagnostic Rheumatology And Research, Pc
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, Llc
Toms River, New Jersey, United States, 08755
United States, New York
The Center For Rheumatology, Llp
Albany, New York, United States, 12206
United States, North Carolina
Rheumatology Clinical Research
Durham, North Carolina, United States, 27704
Physicians East, Pa
Greenville, North Carolina, United States, 27834
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

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Westhovens R, Kremer JM, Moreland LW, Emery P, Russell AS, Li T, Aranda R, Becker JC, Qi K, Dougados M. Safety and efficacy of the selective costimulation modulator abatacept in patients with rheumatoid arthritis receiving background methotrexate: a 5-year extended phase IIB study. J Rheumatol. 2009 Apr;36(4):736-42. Epub 2009 Feb 27.

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00254293 History of Changes
Other Study ID Numbers:	IM101-063
Study First Received:	November 15, 2005
Last Updated:	April 30, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

Abatacept
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2012