A Long Term Roll-over Study to Investigate the Efficacy and Safety of Adalimumab Given Long-term to Patients With Rheumatoid Arthritis

Abbott

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Biological: Adalimumab 40 mg subcutaneous (SC) every other week (EOW)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00233571

DE018

Details and patient eligibility

About

The purpose of the study is to assess the long-term safety and clinical efficacy of adalimumab in patients with rheumatoid arthritis

Enrollment: 796 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completion of a previous D2E7 study
• Subject is in good health (Investigator discretion) with a recent stable medical history

Exclusion criteria

• Former enrollment in this trial (DE018)
• Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study
• Female subject who is pregnant or breast feeding or considering becoming pregnant.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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796 participants in 1 patient group

Adalimumab 40mg subcutaneous (SC) every other week (EOW)

Experimental group

Description:

Adalimumab 40mg subcutaneous (SC) every other week (EOW)

Treatment:

Biological: Adalimumab 40 mg subcutaneous (SC) every other week (EOW)