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

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Abatacept + Vaccines; Drug: Tetanus + pnemococcal vaccines alone

• Registration Number: NCT00279734
• Lead Sponsor: Bristol-Myers Squibb

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

Not available

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Study First Submitted: 2006-01-19
• Study First Submitted QC: 2006-01-19
• Study First Posted: 2006-01-20
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-11
• Last Update Posted: 2011-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 4	Abatacept + Vaccines	-
Group 1	Tetanus + pnemococcal vaccines alone	-
Group 2	Abatacept + Vaccines	-
Group 3	Abatacept + Vaccines	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Qutintiles Phase I Services; 🇺🇸 Lenexa, Kansas, United States

PPD Development; 🇺🇸 Austin, Texas, United States

Parexel International Corp; 🇺🇸 Baltimore, Maryland, United States