Vaccination Study of Abatacept (BMS-188667) for Normal Healthy Volunteers - Tabular View

Tracking Information

First Received Date ^ICMJE

January 19, 2006

Last Updated Date

August 13, 2008

Start Date ^ICMJE

August 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Assess effect of single 750mg dose of Abatacept on antibody response to tetanus toxioid and 23-valent pneumococcal vaccines.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00279734 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Assess safety and tolerability of Abatacept given in conjunction with tetanus toxoid and 23-valent pneumococcal vaccines.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Vaccination Study of Abatacept (BMS-188667) for Normal Healthy Volunteers

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacodynamics Study

Condition ^ICMJE

Rheumatoid Arthritis

Intervention ^ICMJE

Drug: Tetanus + pnemococcal vaccines alone
Drug: Abatacept + vaccines
Drug: Abatacept + Vaccines

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00279734

Responsible Party

Study ID Numbers ^ICMJE

IM101-049

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP