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

This study has been completed.
Information provided by:
Bristol-Myers Squibb Identifier:
First received: January 19, 2006
Last updated: April 11, 2011
Last verified: April 2011
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.

Condition Intervention Phase
Rheumatoid Arthritis Drug: Tetanus + pnemococcal vaccines alone Drug: Abatacept + vaccines Drug: Abatacept + Vaccines Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

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

Secondary Outcome Measures:
  • Assess safety and tolerability of Abatacept given in conjunction with tetanus toxoid and 23-valent pneumococcal vaccines.

Estimated Enrollment: 80
Study Start Date: August 2004
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Drug: Tetanus + pnemococcal vaccines alone
0 mg + vaccines, Single dose, 28 days.
Active Comparator: Group 2 Drug: Abatacept + vaccines
Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 70 days.
Other Name: Orencia
Active Comparator: Group 3 Drug: Abatacept + vaccines
Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 56 days.
Other Name: Orencia
Active Comparator: Group 4 Drug: Abatacept + Vaccines
parenteral, IV, 750 mg abatacept + vaccines, Single dose, 84 days.
Other Name: Orencia


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00279734

United States, Kansas
Qutintiles Phase I Services
Lenexa, Kansas, United States
United States, Maryland
Parexel International Corp
Baltimore, Maryland, United States
United States, Texas
PPD Development
Austin, Texas, United States
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00279734     History of Changes
Other Study ID Numbers: IM101-049
Study First Received: January 19, 2006
Last Updated: April 11, 2011

Keywords provided by Bristol-Myers Squibb:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents processed this record on August 18, 2017