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Tetanus+ pnemococcal vaccines alone

Phase 1

Rheumatoid Arthritis | Small molecule | Immunology |Bristol-Myers Squibb Company|Last Updated: Apr 13, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

Tetanus+ pnemococcal vaccines alone · 1 trial · 1 indication

Phase 1 1
NCT00279734Vaccination Study of Abatacept (BMS-188667) for Normal Healthy VolunteersRheumatoid Arthritis
COMPLETED80 Analytics
PHASE1COMPLETED
Vaccination Study of Abatacept (BMS-188667) for Normal Healthy Volunteers
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Assess safety and tolerability of Abatacept given in conjunction with tetanus toxoid and 23-valent pneumococcal vaccines.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTAL -
Group 2ACTIVE_COMPARATOR -
Group 3ACTIVE_COMPARATOR -
Group 4ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Tetanus + pnemococcal vaccines aloneDRUG0 mg + vaccines, Single dose, 28 days.
Abatacept + vaccinesDRUGParenteral, IV, 750 mg abatacept + vaccines, Single dose, 70 days.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites3

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 disord...

Countries:United States
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Frequently asked questions about Tetanus+ pnemococcal vaccines alone

What is Tetanus+ pnemococcal vaccines alone used for in Rheumatoid Arthritis?

Tetanus+ pnemococcal vaccines alone is a small molecule being studied for use in Rheumatoid Arthritis. It is currently in Phase 1 clinical development as an investigational therapy. The drug is being developed by Bristol-Myers Squibb Company, and it is not yet approved for any use.

Who makes Tetanus+ pnemococcal vaccines alone?

Tetanus+ pnemococcal vaccines alone is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical research on this drug for the treatment of Rheumatoid Arthritis. The drug is currently in Phase 1 development.

What phase is Tetanus+ pnemococcal vaccines alone in?

Tetanus+ pnemococcal vaccines alone is in Phase 1 clinical development. It is an investigational drug being studied for Rheumatoid Arthritis. The drug has completed one Phase 1 trial, and it is not yet approved by regulatory authorities.

What clinical trials is Tetanus+ pnemococcal vaccines alone in?

Tetanus+ pnemococcal vaccines alone has one completed clinical trial, NCT00279734, titled 'Vaccination Study of Abatacept (BMS-188667) for Normal Healthy Volunteers'. This Phase 1 study enrolled 80 participants in the United States and was an active-controlled, randomized trial. The trial is now completed.

Is Tetanus+ pnemococcal vaccines alone FDA approved?

Tetanus+ pnemococcal vaccines alone is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Rheumatoid Arthritis. The drug has completed one clinical trial, but it remains in the early stages of research and has not been approved for any medical use.