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

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00279734

Purpose

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 I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: 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:

MedlinePlus related topics: Rheumatoid Arthritis Tetanus

Drug Information available for: Tetanus Vaccine Abatacept

U.S. FDA Resources

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279734

Locations

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

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tay L, Leon F, Vratsanos G, Raymond R, Corbo M. Vaccination response to tetanus toxoid and 23-valent pneumococcal vaccines following administration of a single dose of abatacept: a randomized, open-label, parallel group study in healthy subjects. Arthritis Res Ther. 2007;9(2):R38.

ClinicalTrials.gov Identifier:	NCT00279734 History of Changes
Other Study ID Numbers:	IM101-049
Study First Received:	January 19, 2006
Last Updated:	April 11, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Rheumatoid Arthritis

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

Abatacept
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012