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A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study and Open-Label Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate Versus Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate


Phase 3
18 Years
N/A
Not Enrolling
Both
Rheumatoid Arthritis

Thank you

Trial Information

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study and Open-Label Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate Versus Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

Inclusion Criteria


- Rheumatoid Arthritis (RA) for greater than 1 year from the time of initial diagnosis
of RA.

- Participants must have been taking methotrexate for at least 3 months with at least a
weekly dose of 15 mg.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Number of American College of Rheumatology 20 (ACR 20) Responders at Day 169

Outcome Description:

ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.

Outcome Time Frame:

Day 169

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

IM101-102

NCT ID:

NCT00048568

Start Date:

December 2002

Completion Date:

October 2009

Related Keywords:

  • Rheumatoid Arthritis
  • Arthritis
  • Arthritis, Rheumatoid

Name

Location

Local InstitutionChicago, Illinois  
Local InstitutionBaltimore, Maryland  
Local InstitutionBronx, New York  
Local InstitutionCincinnati, Ohio  
Local InstitutionGreen Bay, Wisconsin  
Local InstitutionBirmingham, Alabama  
Local InstitutionPhoenix, Arizona  
Local InstitutionCorona, California  
Local InstitutionAurora, Colorado  
Local InstitutionHamden, Connecticut  
Local InstitutionWashington, District of Columbia  
Local InstitutionFort Lauderdale, Florida  
Local InstitutionWichita, Kansas  
Local InstitutionSpringfield, Massachusetts  
Local InstitutionDuluth, Minnesota  
Local InstitutionLincoln, Nebraska  
Local InstitutionNew Brunswick, New Jersey  
Local InstitutionAlbuquerque, New Mexico  
Local InstitutionWilmington, North Carolina  
Local InstitutionOklahoma City, Oklahoma  
Local InstitutionDuncansville, Pennsylvania  
Local InstitutionNorth Charleston, South Carolina  
Local InstitutionAustin, Texas  
Local InstitutionArlington, Virginia