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

AbbVie

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01346501

P12-707

Details and patient eligibility

About

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.

Full 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.

Enrollment: 172 patients

Sex: All

Ages: 20 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Participants with RA who continued the one year observational period of study P12-069 and provided informed consent to participate in study P12-707.

Exclusion criteria

Participants with RA who used biological agents other than adalimumab in the one year observational period of study P12-069.

Trial design

172 participants in 2 patient groups

Adalimumab

Description:

Participants with Rheumatoid Arthritis (RA) who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707. Other name for adalimumab is Humira.

Non-adalimumab

Description:

Patients who discontinued adalimumab treatment after completion of the study M06-859.