A Study of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

NCT00647491 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2008-03-31

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the safety, efficacy and pharmacokinetics of three doses of adalimumab in adult Japanese subjects with RA

Conditions

Interventions

BIOLOGICAL

adalimumab

20 mg sc eow

BIOLOGICAL

adalimumab

40 mg sc eow

BIOLOGICAL

adalimumab

80 mg sc eow

BIOLOGICAL

placebo

placebo sc eow

Sponsors & Collaborators

  • Eisai Limited

    collaborator INDUSTRY
  • Abbott

    lead INDUSTRY

Principal Investigators

  • Shigeki Hashimoto, Ph.D. · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2005-06-30
Completion
2005-08-31

Countries

  • Japan

Study Locations

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Entities

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 NCT00647491 on ClinicalTrials.gov