Post-marketing Observational Study in Subjects With Rheumatoid Arthritis (ReAlise)

Abbott

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Biological: adalimumab

Study type: Observational

Funder types: Industry

Identifiers

NCT00234884

M03-634

Details and patient eligibility

About

The purpose of this observational study was to observe and assess the long term use, safety, and effectiveness of adalimumab in a normal clinical setting.

Full description

This was a multicenter, uncontrolled, 5-year observational study of adalimumab in the treatment of patients with rheumatoid arthritis (RA) who had received adalimumab for at least 3 months in NCT00448383 (Study M02-497), an interventional study that ended when adalimumab became commercially available for the treatment of RA. Participants had to have been receiving ongoing adalimumab treatment at the time NCT00448383 (Study M02-497) ended and been prescribed commercial adalimumab, and could have received commercial adalimumab for up to 1 year afterward prior to enrollment in NCT00234884 (Study M03-634).

Physician investigators were encouraged to treat participants as they would any other patient with RA in their routine clinical practice, and were free to determine the appropriate therapy for each patient. Concomitant treatment with disease-modifying antirheumatic drugs (DMARDs), including methotrexate, could be continued while receiving adalimumab. If treatment with adalimumab was permanently discontinued for any reason, participants were discontinued from the study and the reason was recorded. Investigators were asked to record adverse events up to 3 months after last administration of adalimumab.

Enrollment: 3,435 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with ongoing adalimumab treatment who completed at least Month 3 (Visit 5) of NCT00448383 (Study M02-497) and who had subsequently been prescribed adalimumab according to the Summary of Product Characteristics (SmPC).
• Participants must have been willing to consent to data being collected and provided to Abbott.

Exclusion criteria

· Participants with contraindications according to the SmPC.

Trial design

3,435 participants in 1 patient group

Adalimumab

Description:

RA patients in treatment with commercial adalimumab

Treatment:

Biological: adalimumab