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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00279734
• Other study ID #: IM101-049
• Status: Completed
• Phase: Phase 1
• First received: January 19, 2006
• Last updated: April 11, 2011
• Start date: August 2004
• Est. completion date: January 2005

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Tetanus + pnemococcal vaccines alone
0 mg + vaccines, Single dose, 28 days.
• Abatacept + vaccines
Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 70 days.
• Abatacept + vaccines
Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 56 days.
• Abatacept + Vaccines
parenteral, IV, 750 mg abatacept + vaccines, Single dose, 84 days.

Locations

Country	Name	City	State
United States	PPD Development	Austin	Texas
United States	Parexel International Corp	Baltimore	Maryland
United States	Qutintiles Phase I Services	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess effect of single 750mg dose of Abatacept on antibody response to tetanus toxioid and 23-valent pneumococcal vaccines.
Secondary	Assess safety and tolerability of Abatacept given in conjunction with tetanus toxoid and 23-valent pneumococcal vaccines.

External Links

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