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
  Purpose

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
Rheumatoid Arthritis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Drug Information available for: Adalimumab
U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 7972
Study Start Date: June 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01076959

  Show 1723 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Toshiro Maeda Abbott Japan Co.,Ltd
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01076959     History of Changes
Other Study ID Numbers: P10-559
Study First Received: February 25, 2010
Results First Received: June 29, 2012
Last Updated: August 27, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Abbott:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
 Immune System Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on June 18, 2013