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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00279734
Recruitment Status : Completed
First Posted : January 20, 2006
Last Update Posted : April 13, 2011
Sponsor:
Information provided by:
Bristol-Myers Squibb

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Tetanus + pnemococcal vaccines alone Drug: Abatacept + vaccines Drug: Abatacept + Vaccines Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
Study Start Date : August 2004
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Arms and Interventions
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Arm Intervention/treatment
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


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

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

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

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00279734


Locations
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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
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00279734    
Other Study ID Numbers: IM101-049
First Posted: January 20, 2006    Key Record Dates
Last Update Posted: April 13, 2011
Last Verified: April 2011
Keywords provided by Bristol-Myers Squibb:
Rheumatoid Arthritis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abatacept
 Vaccines
Immunologic Factors
Physiological Effects of Drugs
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Antirheumatic Agents