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Special Investigation in Patients With Rheumatoid Arthritis (Working Productivity Activity Impairment)

This study is currently recruiting participants.
Verified April 2013 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01346488
First received: April 29, 2011
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

Study Objectives

As special investigation (PMOS/non-mandatory) of HUMIRA® subcutaneous injection 40 mg syringe 0.8 mL (generic name: Adalimumab) will be performed to examine the following (1) and (2) for correlation between baseline and follow-up by clinical observation 48 weeks (planned visit time; before the start of treatment, and at 12, 24, 36, and 48 weeks, 4 data collection points) in Japanese rheumatoid arthritis patients who are engaged in paid work and home work.

  1. The primary objective; Situation of work productivity using the Work Productivity and Activity Impairment/General Health questionnaire and functional impairment (daily life activity) using the Modified Health Assessment Questionnaire when HUMIRA® treatment.
  2. The secondary objective; Clinical observation and rate of improvement of the Disease Activity Score 28 when HUMIRA® treatment. Situation of the occurrence of adverse events definition during the course of the observation period while HUMIRA® treatment, other factors considered to affect the safety and effectiveness.

Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Documentation of the Effects on Quality of Life (QOL) and Working Productivity and Activity Impairment (WPAI) in Patients With Rheumatoid Arthritis (RA) Under HUMIRA®(Adalimumab) in Routine Clinical Practice

Resource links provided by NLM:

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

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Work Productivity and Activity Impairment-Rheumatoid Arthritis [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
  • Work Productivity and Activity Impairment-Rheumatoid Arthritis [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Work Productivity and Activity Impairment-Rheumatoid Arthritis [ Time Frame: at week 36 ] [ Designated as safety issue: No ]
  • Work Productivity and Activity Impairment-Rheumatoid Arthritis [ Time Frame: at week 48 ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire [ Time Frame: at week 36 ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire [ Time Frame: at week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: at week 48 ] [ 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

  • Disease activity Score 28 [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
  • Disease activity Score 28 [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Disease activity Score 28 [ Time Frame: at week 36 ] [ Designated as safety issue: No ]
  • Disease activity Score 28 [ Time Frame: at week 48 ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: June 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 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

Single-arm, Multi-center, Prospective Cohort

Criteria

Inclusion Criteria:

  • The subject of Non-interventional study are Rheumatoid arthritis patients (only those with insufficient response to the existing treatment) and to whom HUMIRA® is administered.

Exclusion Criteria:

  1. Rheumatoid arthritis patients showing lowered basic activities of daily life, such as hospitalization and being bedridden
  2. Rheumatoid arthritis patients who are pregnant or may be pregnant (only when the physician can ascertain it)
  3. Rheumatoid arthritis patients who are participating in another clinical trial of a drug of the same type and effectiveness
  4. Other cases that the physician in charge judges to be unfavorable as the subject of this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346488

Contacts
Contact: AbbVie Japan PMOS Desk +81-3-4588-4621 abvj-pmos@abbvie.com
Contact: Toshiro Maeda toshiro.maeda@abbvie.com

  Show 395 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Toshiro Maeda AbbVie GK
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01346488     History of Changes
Other Study ID Numbers: P12-772
Study First Received: April 29, 2011
Last Updated: April 22, 2013
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 May 19, 2013