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A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate


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

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Trial Information

A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate


Inclusion Criteria:



- Diagnosis of rheumatoid arthritis (RA) <=2 years; MTX naive or <=10 mg/wk for <=3
weeks. No dose within 3 months prior to informed consent.

- C-Reactive Protein (CRP) >= 4.5 mg/L (after amendment)

- Rheumatoid factor or anti-cyclic citrullinated peptide antibody (anti-CCP) positive

- Tender joints >=12 and swollen joints >=10

Exclusion Criteria:

- Women and men who are not willing to use birth control

- Diagnosed with other rheumatic disease

- History of cancer within 5 years

- Active tuberculosis

- Treatment with another investigation drug within 28 days

- Active bacterial or viral infection

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants in DAS 28 C-reactive Protein (CRP) Remission at Month 12

Outcome Description:

Number of participants who achieved remission at Month 12 of treatment, as defined by a Disease Activity Score (DAS) 28-CRP score of <2.6. DAS 28-CRP is a continuous measure, a composite of 4 variables: number of tender joints out of 28 joints, number of swollen joints out of 28 joints, CRP (in mg/L), and subject assessment of disease activity measure on a Visual Analogue Scale (VAS) of 100 millimeters (mm). The DAS28 scale=0 (best) to 10 (worst), indicating the current activity of the rheumatoid arthritis. A DAS28 >5.1 = high disease activity; <=3.2 = low disease activity; <2.6 = remission.

Outcome Time Frame:

Month 12

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

IM101-023

NCT ID:

NCT00122382

Start Date:

July 2005

Completion Date:

February 2009

Related Keywords:

  • Rheumatoid Arthritis
  • abatacept, methotrexate, erosive RA
  • Arthritis
  • Arthritis, Rheumatoid

Name

Location

Altoona Center for Clinical ResearchDuncansville, Pennsylvania  16635
Rheumatology Associates Of North AlabamaHuntsville, Alabama  35801
Talbert Medical GroupHuntington Beach, California  92646
Arthritis Assoc And Osteo Ctr Of Col SprgsColorado Springs, Colorado  80910
New England Research Associates, LlcTrumbull, Connecticut  06611
Diagnostic Rheumatology And ResearchIndianapolis, Indiana  46227
Osteoporosis And Clinical Trials CenterCumberland, Maryland  21502
Malamet & Klein, Md, PaHagerstown, Maryland  21740
Arthritis Center Of NebraskaLincoln, Nebraska  68516
Regional Rheumatology AssociatesBinghamton, New York  13905
Carolina Bone & JointCharlotte, North Carolina  28210
Physicians East, PaGreenville, North Carolina  27834
Carolina Pharmaceutical ResearchStatesville, North Carolina  28625
Lion ResearchNorman, Oklahoma  73071
Health Research Of OklahomaOklahoma City, Oklahoma  73103
Lynn Health Sciences InstituteOklahoma City, Oklahoma  73112
Low Country Research CenterCharleston, South Carolina  29406
Walter F Chase Md PaAustin, Texas  78705
Arthritis Clinic Of Northern Virginia, P.C.Arlington, Virginia  22205