Back to resultsVaccination Study of Abatacept (BMS-188667) for Normal Healthy Volunteers
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tetanus + pnemococcal vaccines alone
Abatacept + vaccines
Abatacept + vaccines
Abatacept + Vaccines
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria: Healthy Subjects Body Weight between 60 and 100 kg. Males and Females must be using adequate contraceptive methods during study and for 10 weeks after dose of study mediciation. Exclusion Criteria: Females who are prgnant or breastfeeding History of autoimmune disorder, immunodeficiency, or infection within past 3 months. Active TB requiring treatment within the previous 3 years. Positive breast cancer screen, PPD test. Vaccination with tetanus or pneumococcal vaccine within 5 years. Vaccination with any live vaccine within 4 weeks. History of drug or alcohol abuse. Any significant allergy.
Sites / Locations
- Qutintiles Phase I Services
- Parexel International Corp
- PPD Development
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Group 3
Group 4
Arm Description
Outcomes
Primary Outcome Measures
Assess effect of single 750mg dose of Abatacept on antibody response to tetanus toxioid and 23-valent pneumococcal vaccines.
Secondary Outcome Measures
Assess safety and tolerability of Abatacept given in conjunction with tetanus toxoid and 23-valent pneumococcal vaccines.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00279734
Brief Title
Vaccination Study of Abatacept (BMS-188667) for Normal Healthy Volunteers
Official Title
An Exploratory Study to Evaluate the Effect of Abatacept (BMS-188667) on the Antibody Response Following Tetanus Toxoid and 23-Valent Pneumococcal Vaccinations in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
5. Study Description
Brief Summary
Study to assess the ability of healthy subjects to build anitbodies to tetanus and pneumococcal vaccines after receiving a single intravenous dose of Abatacept, a drug which is being developed for the treatment of Rheumatoid Arthritis and which can affect the immune system.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Title
Group 2
Arm Type
Active Comparator
Arm Title
Group 3
Arm Type
Active Comparator
Arm Title
Group 4
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tetanus + pnemococcal vaccines alone
Intervention Description
0 mg + vaccines, Single dose, 28 days.
Intervention Type
Drug
Intervention Name(s)
Abatacept + vaccines
Other Intervention Name(s)
Orencia
Intervention Description
Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 70 days.
Intervention Type
Drug
Intervention Name(s)
Abatacept + vaccines
Other Intervention Name(s)
Orencia
Intervention Description
Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 56 days.
Intervention Type
Drug
Intervention Name(s)
Abatacept + Vaccines
Other Intervention Name(s)
Orencia
Intervention Description
parenteral, IV, 750 mg abatacept + vaccines, Single dose, 84 days.
Primary Outcome Measure Information:
Title
Assess effect of single 750mg dose of Abatacept on antibody response to tetanus toxioid and 23-valent pneumococcal vaccines.
Secondary Outcome Measure Information:
Title
Assess safety and tolerability of Abatacept given in conjunction with tetanus toxoid and 23-valent pneumococcal vaccines.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy Subjects
Body Weight between 60 and 100 kg.
Males and Females must be using adequate contraceptive methods during study and for 10 weeks after dose of study mediciation.
Exclusion Criteria:
Females who are prgnant or breastfeeding
History of autoimmune disorder, immunodeficiency, or infection within past 3 months.
Active TB requiring treatment within the previous 3 years.
Positive breast cancer screen, PPD test.
Vaccination with tetanus or pneumococcal vaccine within 5 years.
Vaccination with any live vaccine within 4 weeks.
History of drug or alcohol abuse.
Any significant allergy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Qutintiles Phase I Services
City
Lenexa
State/Province
Kansas
Country
United States
Facility Name
Parexel International Corp
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
PPD Development
City
Austin
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17425783
Citation
Tay L, Leon F, Vratsanos G, Raymond R, Corbo M. Vaccination response to tetanus toxoid and 23-valent pneumococcal vaccines following administration of a single dose of abatacept: a randomized, open-label, parallel group study in healthy subjects. Arthritis Res Ther. 2007;9(2):R38. doi: 10.1186/ar2174.
Results Reference
derived
Learn more about this trial
Vaccination Study of Abatacept (BMS-188667) for Normal Healthy Volunteers
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