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

Abbott

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Biological: Adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00603993

M05-775

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completed Week 36 of Study M03-651 [NCT 00235872]
• Wish to participate in self-injection study
• Give written informed consent
• Comply with protocol requirements

Exclusion criteria

• Subject develops serious adverse events at time of eligibility confirmation
• Subject develops severe infections requiring hospitalization or IV injection of antibiotics within 28 days before eligibility confirmation
• Subject develops infections requiring oral administration of antibiotics within 14 days before eligibility confirmation
• The investigator considers the subject inappropriate for participation

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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88 participants in 1 patient group

Adalimumab

Experimental group

Description:

Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 \[NCT 00235872\]) subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan

Treatment:

Biological: Adalimumab