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

NCT01736189 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 346

Last updated 2019-07-02

Study results available
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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.

Conditions

Interventions

DRUG

Adalimumab

Pre-filled syringe, administered by subcutaneous injection

Sponsors & Collaborators

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • AbbVie Inc. · AbbVie

Eligibility

Min Age
16 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-11
Primary Completion
2018-04-16
Completion
2018-04-16

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01736189 on ClinicalTrials.gov