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Abatacept With Methotrexate- Phase IIB

NCT00162266 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 524

Last updated 2012-06-01

Study results available
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Summary

This study was conducted to assess the safety and tolerability of Abatacept combined with Methotrexate in participants with active rheumatoid arthritis (RA). The secondary objectives were to assess efficacy, pharmacodynamic marker activity, and immunogenicity of Abatacept combined with Methotrexate.

Conditions

Interventions

DRUG

Abatacept (BMS-188667)

IV, 10 mg/Kg, monthly, for the duration of the trial

DRUG

Abatacept (BMS-188667)

Intravenous (IV) infusion, 2 mg/kg, infused intravenously for approximately 30 min, infusions on Days 1, 15, 30 and monthly thereafter for 12 months

DRUG

Abatacept (BMS-188667)

Intravenous (IV) infusion, 10 mg/kg, infused intravenously for approximately 30 min, infusions on Days 1, 15, 30 and monthly thereafter for 12 months

DRUG

Placebo

Intravenous (IV) infusion, 0 mg/kg, infused intravenously for approximately 30 min, infusions on Days 1, 15, 30 and monthly thereafter for 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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-10-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • Ireland
  • Netherlands
  • South Africa
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT00162266 on ClinicalTrials.gov