NCT01736189

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

Assessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical Practice (Combo Study; Adalimumab With High Dose MTX)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 346 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 16 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Adalimumab	Pre-filled syringe, administered by subcutaneous injection

Timeline

• Start date: 2012-10-11
• Primary completion: 2018-04-16
• Completion: 2018-04-16
• First posted: 2012-11-29
• Last updated: 2019-07-02
• Results posted: 2019-07-02