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

Sponsor
AbbVie (prior sponsor, Abbott)
Study ID
NCT01736189
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    Pre-filled syringe, administered by subcutaneous injection

Study Details

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.

Key Dates

Start date
Oct 11, 2012
Status verified
Jun 2019
Primary completion
Apr 16, 2018
Completion
Apr 16, 2018

Study Design

Enrollment
346 participants (actual)

Arms

  • Arm: Participants treated with adalimumab
    40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 104 weeks

Primary Outcome Measure

Percentage of Participants With a Disease Activity Score 28 (DAS28) Score of <2.6 at Week 52 [ Time Frame: At Week 52 ]

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