Special Investigation of Humira on Long-term Treatment in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01163318
First received: July 14, 2010
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

The present survey will be conducted to collect information on the safety (especially the development of malignant tumors, infections, and other untoward events) and effectiveness of Humira 40 mg/0.8 mL Syringe for Subcutaneous Injection (Humira) in patients receiving the drug for a long period of time for the treatment of rheumatoid arthritis, for the purpose of investigating and confirming factors affecting the safety and effectiveness of the drug.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Investigation (Long-term Treatment in Patients With Rheumatoid Arthritis)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Evaluation of adverse event [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]
    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

  • Evaluation of adverse event [ Time Frame: at 1.5 years ] [ Designated as safety issue: Yes ]
    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

  • Evaluation of adverse event [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]
    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

  • Evaluation of adverse event [ Time Frame: at 2.5 years ] [ Designated as safety issue: Yes ]
    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

  • Evaluation of adverse event [ Time Frame: at 3 years ] [ Designated as safety issue: Yes ]
    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

  • Improvement rating on the basis of Disease Activity Score28 [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • Improvement rating on the basis of Disease Activity Score28 [ Time Frame: at 1.5 years ] [ Designated as safety issue: No ]
  • Improvement rating on the basis of Disease Activity Score28 [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
  • Improvement rating on the basis of Disease Activity Score28 [ Time Frame: at 2.5 years ] [ Designated as safety issue: No ]
  • Improvement rating on the basis of Disease Activity Score28 [ Time Frame: at 3 years ] [ Designated as safety issue: No ]
  • Modified Health Assessment Questionnaire [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • Modified Health Assessment Questionnaire [ Time Frame: at 1.5 years ] [ Designated as safety issue: No ]
  • Modified Health Assessment Questionnaire [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
  • Modified Health Assessment Questionnaire [ Time Frame: at 2.5 years ] [ Designated as safety issue: No ]
  • Modified Health Assessment Questionnaire [ Time Frame: at 3 years ] [ Designated as safety issue: No ]

Enrollment: 553
Study Start Date: December 2009
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Humira
Those with an exposure

  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

Those who are receiving Humira in accordance with its indications for treatment and dosage regimens

Criteria

Inclusion Criteria:

  • Those who are receiving Humira in accordance with its indications for treatment and dosage regimens
  • Those who are using Humira continuously
  • Those with no current and no past history of malignant tumor
  • Those evaluable for Disease Activity Score28-4erythrocyte sedimentation rate
  • Patients who have been evaluated by Health Assessment Questionnaire or Modified Health Assessment Questionnaire prior to initiation of Humira treatment (prior to initial administration of Humira in the all-case 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01163318

  Show 122 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Aki Kuroki AbbVie GK
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01163318     History of Changes
Other Study ID Numbers: P12-070
Study First Received: July 14, 2010
Last Updated: June 3, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AbbVie:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014