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

Completed · Phase 1

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT00279734

Run by

Bristol-Myers Squibb

People needed

80

Starts

2004-08-01

Expected to finish

2005-01-01

Last updated by the study team

2011-04-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Qutintiles Phase I Services — Lenexa, Kansas, United States
• Parexel International Corp — Baltimore, Maryland, United States
• PPD Development — Austin, Texas, United States

Full record on ClinicalTrials.gov

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