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A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis

NCT00870467 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2012-08-07

Study results available
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Summary

To evaluate the potential of adalimumab to inhibit radiographic progression in joint destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid arthritis.

Conditions

Interventions

BIOLOGICAL

Double-blind adalimumab

Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)

DRUG

Double-blind Placebo

Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)

BIOLOGICAL

Open-label Adalimumab

Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study

BIOLOGICAL

Open-labelAdalimumabRescue

Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) as rescue treatment to complete the first 26 weeks in the study- dependent on participant eligibility (increase in disease activity), applies to Weeks 12 to 26

Sponsors & Collaborators

  • Eisai Co., Ltd.

    collaborator INDUSTRY

  • Abbott

    lead INDUSTRY

Principal Investigators

  • Hiroshi Ukai, BS · Abbott Japan Co.,Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-03-31
Completion
2011-08-31

Countries

  • Japan

Study Locations

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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 NCT00870467 on ClinicalTrials.gov