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Self-injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

NCT00603993 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2011-06-21

Study results available
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Summary

The purpose of this study is to evaluate the long-term safety of subcutaneous (SC) self-injections (by the subject or subject's family member) of adalimumab in adult Japanese subjects with Rheumatoid Arthritis in an open-label study.

Conditions

Interventions

BIOLOGICAL

Adalimumab

40 mg or 80 mg every other week (eow), subcutaneous (sc), self-injection

Sponsors & Collaborators

  • Abbott Japan Co.,Ltd

    collaborator INDUSTRY

  • Eisai Co., Ltd.

    collaborator INDUSTRY

  • Abbott

    lead INDUSTRY

Principal Investigators

  • Shigeki Hashimoto, PhD · Abbott Japan

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2006-11-30

Countries

  • Japan

Study Locations

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Entities

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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 NCT00603993 on ClinicalTrials.gov