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Phase IIIB Subcutaneous Abatacept Monotherapy Study

NCT00547521 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2015-03-23

Study results available
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Summary

To evaluate safety and immunogenicity of abatacept when used with or without methotrexate in the absence of an IV loading dose of abatacept

Conditions

  • Rheumatoid Arthritis (RA)

Interventions

DRUG

abatacept

solution, subcutaneous injection, 125 mg/kg, weekly, 106 days in short term; long term is open

DRUG

Methotrexate (MTX)

Participants who were currently receiving methotrexate at a stable dose ≥ 10 mg for at least 4 weeks

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2008-12-31
Completion
2014-02-28

Countries

  • United States
  • Australia
  • Mexico
  • South Africa

Study Locations

More Related Trials

Entities

Drugs
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 NCT00547521 on ClinicalTrials.gov