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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01076959
Recruitment Status : Completed
First Posted : February 26, 2010
Results First Posted : August 7, 2012
Last Update Posted : August 28, 2012
Sponsor:
Information provided by (Responsible Party):
Abbott

Study Description
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Brief Summary:

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

Condition or disease
Rheumatoid Arthritis

Study Design
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Study Type : Observational
Actual Enrollment : 7972 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Humira 40 mg/0.8 mL for Subcutaneous Injection - Drug Use Investigation (All Patient Investigation) for Rheumatoid Arthritis
Study Start Date : June 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Groups and Cohorts
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Group/Cohort
Humira
The sponsor was required to include all patients diagnosed with rheumatoid arthritis and who were treated Humira in routine medical practice during the review period by the PMDA. The safety analysis set included all patients who met all eligibility criteria and received at least one dose of Humira. The full analysis set included all patients who were treated with Humira for at least 2 weeks and had complete DAS 28 assessments at baseline and at least one other time point.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients prescribed and treated with Humira included in this survey.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076959


Locations
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Sponsors and Collaborators
Abbott
Investigators
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Study Director: Toshiro Maeda Abbott Japan Co.,Ltd
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01076959    
Other Study ID Numbers: P10-559
First Posted: February 26, 2010    Key Record Dates
Results First Posted: August 7, 2012
Last Update Posted: August 28, 2012
Last Verified: August 2012
Keywords provided by Abbott:
Rheumatoid Arthritis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases