NCT01163318

Special Investigation of Humira® (Adalimumab) on Long-term Treatment in Patients With Rheumatoid Arthritis

Special Investigation (Long-term Treatment in Patients With Rheumatoid Arthritis)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 552 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to collect data on the incidence of adverse drug reactions, infections and malignant tumors, as well as factors that might affect the safety and effectiveness of Humira® (adalimumab; 40mg/0.8 mL) in Japanese participants who received the drug for the treatment of rheumatoid arthritis.

Detailed description

Rheumatoid arthritis is a chronic autoimmune disease which requires long-term treatment. Due to the need of long-term safety data in Japanese participants and to fulfil the conditions of approval of adalimumab by the Japanese regulatory authority, this post-marketing observational study (PMOS) was conducted. The study investigated the long-term safety of adalimumab, particularly associated with the development of infections and malignant tumors. Data was collected once every 6 months up to 3 years.

Conditions

• Rheumatoid Arthritis

Timeline

• Start date: 2009-12-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2010-07-15
• Last updated: 2015-06-10
• Results posted: 2015-06-10