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OpenTrials
Completed

NCT Number: NCT01076959

Drug Use Investigation for Humira® - All Patient Investigation for Rheumatoid Arthritis

To clarify the following matters:

* Unknown adverse reactions (especially clinically significant adverse reactions) * Incidence and conditions of occurrence of adverse reactions in the clinical setting * Factors that may affect the safety and effectiveness of Humira

Completed

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site Reference ID/Investigator# 35904, Aichi, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients prescribed and treated with Humira are included in this survey.

Exclusion criteria

  • Contraindications according to the Package Insert:
  • Patients who have serious infections,
  • Patients who have tuberculosis,
  • Patients with a history of hypersensitivity to any ingredient of Humira,
  • Patients who have demyelinating disease or with a history of demyelinating disease,
  • Patients who have cardiac failure congestive.

Treatment and study plan

Primary outcomes

  1. Total Number of Patients With Adverse Events

    Time frame: Baseline to Week 24

    Adverse events were assessed from the time treatment began until treatment ended after 24 weeks. Details about the adverse events and serious adverse events are presented with the adverse event section of the disclosure. This outcome is measured as a percentage of patients with adverse events.

  2. Patient Effectiveness Response Rating and Effective Rate of Humira With Disease Activity Score (DAS) 28 at Week 4

    Time frame: Week 4

    Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 4. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).

  3. Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 12

    Time frame: Week 12

    Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 12. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).

  4. Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 24

    Time frame: Week 24

    Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 24. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).

Secondary outcomes

  1. Physicians' Overall Effectiveness Response Rating

    Time frame: Week 24

    Physicians' rated the level of overall patient improvement as "markedly improved," "improved," "not changed," or "not assessable" by comparing clinical conditions at Week 24 or at discontinuation with baseline conditions.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

Humira 40 mg/0.8 mL for Subcutaneous Injection - Drug Use Investigation (All Patient Investigation) for Rheumatoid Arthritis

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Feb 26, 2010
Registry last updated
Aug 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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