Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01076959
First received: February 25, 2010
Last updated: August 27, 2012
Last verified: August 2012
History of Changes

February 25, 2010
August 27, 2012
June 2008
June 2011   (final data collection date for primary outcome measure)
  • Total Number of Patients With Adverse Events [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: Yes ]
    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.
  • Patient Effectiveness Response Rating and Effective Rate of Humira With Disease Activity Score (DAS) 28 at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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).
  • Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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).
  • Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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).
  • Evaluation of adverse event (occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira) [ Time Frame: at weeks 24 ] [ Designated as safety issue: Yes ]
  • Improvement rating on the basis of Disease Activity Score28 [ Time Frame: at weeks 4 , 12 and 24 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01076959 on ClinicalTrials.gov Archive Site
Physicians' Overall Effectiveness Response Rating [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
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.
Efficacy evaluation by the investigator [ Time Frame: at weeks 24 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Drug Use Investigation for Humira® - All Patient Investigation for Rheumatoid Arthritis
Humira 40 mg/0.8 mL for Subcutaneous Injection - Drug Use Investigation (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
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

All patients prescribed and treated with Humira included in this survey.
Rheumatoid Arthritis
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7972
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01076959
P10-559
Not Provided
Abbott
Abbott
Not Provided
Study Director: Toshiro Maeda Abbott Japan Co.,Ltd
Abbott
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP