NCT01346501

Special Investigation in Patients With Rheumatoid Arthritis (HOPEFUL III Study), a Follow-up Survey of Study P12-069

An Extended Observational Study (P12-707: HOPEFUL III Study) of Follow-up Survey (P12-069: HOPEFUL II Study) of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 172 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 20 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study was to determine the ability to maintain response after discontinuation of adalimumab treatment and the secondary objective was to determine radiographic progression in participants participating in the study, including the percentage who displayed minimal progression.

Detailed description

This was a two-arm, multi-center, Post Marketing Observational Study (PMOS) conducted in Japanese participants with Rheumatoid Arthritis (RA) who continued the one year observational period of study P12-069 (HOPEFUL II study; NCT01163292) and provided informed consent to participate in study P12-707 (HOPEFUL III study; NCT01346501), after completion of study M06-859 (HOPEFUL I study; NCT00870467). The study P12-707 provided an additional two years of observation for those participants who participated in study P12-069.

Conditions

• Rheumatoid Arthritis

Timeline

• Start date: 2011-04-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2011-05-03
• Last updated: 2016-03-11
• Results posted: 2016-03-11