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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00279734

IM101-049

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Group 1

Experimental group

Treatment:

Drug: Tetanus + pnemococcal vaccines alone

Group 2

Active Comparator group

Treatment:

Drug: Abatacept + vaccines

Drug: Abatacept + vaccines

Group 3

Active Comparator group

Treatment:

Drug: Abatacept + vaccines

Drug: Abatacept + vaccines

Group 4

Active Comparator group

Treatment:

Drug: Abatacept + Vaccines