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

This study has been completed.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
First received: April 29, 2011
Last updated: January 25, 2016
Last verified: January 2016

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.

Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Investigation (Working Productivity and Activity Impairment / WPAI in Japanese Patients With Rheumatoid Arthritis / RA)

Resource links provided by NLM:

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 ]

Enrollment: 2085
Study Start Date: June 2011
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Those with an exposure


Ages Eligible for Study:   16 Years to 99 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Single-arm, Multi-center, Prospective Cohort

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:

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

  Show 461 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Study Director: Sarina Kurimoto, MD AbbVie GK
  More Information

Additional Information:
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: January 25, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AbbVie:
Rheumatoid arthritis

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

ClinicalTrials.gov processed this record on May 26, 2016