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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00279734Vaccination Study of Abatacept (BMS-188667) for Normal Healthy VolunteersPHASE1 COMPLETED 80Aug 1, 2004Jan 1, 2005Apr 13, 20113 United States
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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 — 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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