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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

346 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-11

Study Completion Date

2018-04-16

Brief Summary

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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.

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Detailed Description

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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

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants treated with adalimumab

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

Adalimumab

Intervention Type DRUG

Pre-filled syringe, administered by subcutaneous injection

Interventions

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Adalimumab

Pre-filled syringe, administered by subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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Humira ABT-D2E7

Eligibility Criteria

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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