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Efficacy and Safety of Adalimumab and Methotrexate (MTX) Versus MTX Monotherapy in Subjects With Early Rheumatoid Arthritis

NCT00195663 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 799

Last updated 2013-07-12

Study results available
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Summary

The purpose of the study is to assess the safety and efficacy of adalimumab in combination with methotrexate in patients with recent onset rheumatoid arthritis (RA), and to assess the long-term safety and maintenance of efficacy after treatment with adalimumab for up to 10 years.

Conditions

  • Early Rheumatoid Arthritis

Interventions

BIOLOGICAL

Adalimumab

DRUG

Methotrexate

BIOLOGICAL

Adalimumab placebo

DRUG

Methotrexate placebo

Sponsors & Collaborators

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Dawn Carlson · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-12-31
Primary Completion
2004-04-30
Completion
2012-04-30

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Norway
  • Slovakia
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT00195663 on ClinicalTrials.gov