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Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis

NCT00095147 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 431

Last updated 2015-03-24

Study results available
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Summary

The purpose of this clinical research study is to learn if Abatacept or Infliximab in combination with Methotrexate demonstrate a greater reduction in disease activity over placebo.

Conditions

Interventions

DRUG

Abatacept (ABA) + Methotrexate (MTX), double-blind (DB)

Abatacept, intravenous (IV) Solution, Infusion, Depends on participant weight, Monthly, 12 months.

DRUG

Infliximab (INF) + MTX, DB

Infliximab, IV Solution, Infusion, Depends on participant weight, Every 2 Months, 12 months.

DRUG

Placebo (PLA) + MTX, DB

Placebo, IV Solution, Infusion, Depends on participant weight, Monthly, 6 months.

DRUG

PLA + MTX switched to ABA+ MTX, DB

Placebo=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months. Abatacept=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months

DRUG

ABA, open-label (OL)

Abatacept, IV solution, Infusion. Depends on participant weight, Monthly, 12+ months

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • Czechia
  • Denmark
  • Mexico
  • Peru
  • Poland
  • Puerto Rico
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00095147 on ClinicalTrials.gov