Assessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical Practice

AbbVie

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: Adalimumab

Study type: Observational

Funder types: Industry

Identifiers

NCT01736189

P13-684

Details and patient eligibility

About

This was a single-arm, multicenter, open label, prospective cohort study (post-marketing observational study) to determine the effectiveness and safety of adalimumab in combination with high-dose methotrexate (≥12 mg/week) in participants with rheumatoid arthritis in a routine clinical setting in Japan.

Full description

Study assessments occurred at baseline, Week 12, Week 24, Week 52, Week 76, and Week 104. Most participants received 40 mg of adalimumab every other week during the study. Two participants started at 40 mg of adalimumab every other week, and increased to 80 mg every other week. A few participants had a different dose regimen: 40 mg every three weeks for 3 participants; 40 mg every four weeks for 1 participant; and 40 mg every other week with a switch to 50 mg every three weeks for 4 subjects.

Enrollment: 346 patients

Sex: All

Ages: 16 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

The participants of this study were rheumatoid arthritis (RA) patients for whom adalimumab was prescribed. They must have met the following conditions:

• Disease duration of RA ≤2 years
• Methotrexate (MTX) administration ≥3 months prior to starting adalimumab
• Dose of MTX ≥12mg/week
• Disease Activity Score 28 (DAS28)-C-reactive protein (CRP) score >3.2

Exclusion criteria

• Participants who had been previously treated with biologics (including tumor necrosis factor [TNF] inhibitors and others)

Trial design

346 participants in 1 patient group

Participants treated with adalimumab

Description:

40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 104 weeks

Treatment:

Drug: Adalimumab