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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01346488
First received: April 29, 2011
Last updated: March 16, 2017
Last verified: March 2017
  Purpose

This is a single-arm, multi-center, prospective cohort study (post-marketing observational study). The observation period for each participant is 48 weeks.

This study is designed to provide additional data on treatment effects of adalimumab during 48 weeks of treatment in patients with RA under conditions of routine rheumatology care. Course of work productivity and work ability, the course of health-related quality of life, and changes in functionality during 48 weeks treatment with adalimumab are to be documented.


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:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) [ Time Frame: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of adalimumab (ADA) therapy, and at final assessment (up to Week 48) ]
    Absenteeism, presented as the mean percentage of work time missed due to RA (as reported on the WPAI-RA), and calculated as: 100*number of hours of work missed due to RA / (number of hours of work missed due to RA + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. "Change" was calculated as the value at baseline minus the value at each subsequent time point.

  • Change From Baseline in WPAI Questionnaire: Mean Percentage of Impairment While Working Due to RA (Presenteeism) [ Time Frame: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and at final assessment (up to Week 48) ]
    Presenteeism (the extent to which RA decreased productivity) is presented as the mean percentage of impairment while working due to RA, and calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. "Change" was calculated as the value at baseline minus the value at each subsequent time point.

  • Change From Baseline in WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to RA [ Time Frame: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and at final assessment (up to Week 48) ]
    The mean percentage of OWPI due to RA (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which RA decreased productivity (%)* [number of hours worked / (number of hours of work missed due to RA + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. "Change" was calculated as the value at baseline minus the value at each subsequent time point.

  • Change From Baseline in WPAI Questionnaire: Mean Percentage of Activity Impairment Due to RA [ Time Frame: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) ]
    Activity impairment due to RA (the extent to which RA affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. "Change" was calculated as the value at baseline minus the value at each subsequent time point.

  • Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score [ Time Frame: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) ]
    The HAQ-DI is a patient-reported questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (no disability) to 3 (very severe, high-dependency disability). A negative change from Baseline in the score indicates improvement.

  • Number of Participants Per Category of the HAQ-DI [ Time Frame: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) ]
    The HAQ-DI is a patient-reported questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (no disability) to 3 (very severe, high-dependency disability). Categories were defined as: high (> 1.5), moderate (≤ 1.5 to > 1.0), low (≤ 1.0 to > 0.5), remission (≤ 0.5 to > 0), 0 (0).


Secondary Outcome Measures:
  • Change From Baseline in Disease Activity Score 28-4 C-Reactive Protein (DAS 28-4 CRP) [ Time Frame: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) ]
    DAS28-4 CRP was calculated using the number of tender and swollen joints (out of 28 counted), CRP level, and the participant's global assessment of disease activity via a visual analog scale (VAS). The calculated range of DAS28-4 is 0 (no disease activity) to 10 (maximal disease activity). A decrease from Baseline in score indicates improvement of disease activity.

  • Number of Participants Per Category of the DAS28-4 CRP [ Time Frame: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) ]
    DAS28-4 CRP was calculated using the number of tender and swollen joints (out of 28 counted), CRP level, and the participant's global assessment of disease activity via a VAS. The calculated range of DAS28-4 is 0 (no disease activity) to 10 (maximal disease activity). Categories were defined as: high (> 5.1), moderate (≤ 5.1 to > 3.2), low (≤ 3.2 to ≥ 2.6), remission (< 2.6).

  • Change From Baseline in DAS28-4 Erythrocyte Sedimentation Rate (ESR) [ Time Frame: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) ]
    DAS28-4 ESR, a combined index that measures activity of RA, was calculated based on the number of tender and swollen joints (out of 28 counted), general health evaluated by a VAS, and ESR. DAS28-4 ESR scores ranged from 0 (no disease activity) to 10 (maximal disease activity). A decrease from Baseline in scores indicates improvement of disease activity.

  • Number of Participants Per Category of the DAS28-4 ESR [ Time Frame: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) ]
    DAS28-4 ESR, a combined index that measures activity of RA, was calculated based on the number of tender and swollen joints (out of 28 counted), general health evaluated by a VAS, and ESR. DAS28-4 ESR scores ranged from 0 (no disease activity) to 10 (maximal disease activity). Categories were defined as: high (> 5.1), moderate (≤ 5.1 to > 3.2), low (≤ 3.2 to ≥ 2.6), remission (< 2.6).

  • Change From Baseline in Clinical Disease Activity Index (CDAI) [ Time Frame: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) ]
    The CDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a VAS from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 (lowest disease activity) to 76 (highest disease activity). "Change" was calculated as the value at baseline minus the value at each subsequent time point.

  • Number of Participants Per Category of the CDAI [ Time Frame: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) ]
    The CDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a VAS from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 (lowest disease activity) to 76 (highest disease activity). Categories were defined as: high (> 22.1), moderate (≤ 22.0 to > 10.0), low (≤ 10.0 to < 2.8), and remission (≤ 2.8).

  • Change From Baseline in European Quality of Life-5 Dimensions Questionnaire (EQ-5D) Summary Index Score [ Time Frame: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) ]
    The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.594 to 1 (with higher scores indicating better health state). "Change" was calculated as the value at baseline minus the value at each subsequent time point.

  • Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and Deaths [ Time Frame: up to Week 52 ]
    AEs, which were defined as any untoward medical occurrence observed in participants who received adalimumab in this study, were summarized.

  • Number of Participants With Adverse Drug Reactions [ Time Frame: up to Week 52 ]
    Adverse drug reactions were defined as AEs of which a causal relationship with adalimumab could not be ruled out.


Enrollment: 2088
Study Start Date: June 2011
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adalimumab
Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).

Detailed Description:
This study was designed as a non-interventional observational study. Adalimumab was prescribed in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines.
  Eligibility

Ages Eligible for Study:   15 Years to 87 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Single-arm, Multi-center, Prospective Cohort
Criteria

Inclusion Criteria:

RA patients treated with adalimumab who satisfied the following conditions:

  1. Paid worker (PW) RA patients who are engaged in paid work for more than 35 hours per week
  2. Home worker (HW)

    • Category 1 unpaid workers; RA patients who are engaged in paid work for less than 35 hours per week
    • Category 2 unpaid workers; RA patients who perform basic activities of daily life (household duties, shopping, child caring, exercise, study, etc.) other than PW

Exclusion Criteria:

  1. RA patients showing lowered basic activities of daily life, such as hospitalization and being bedridden
  2. RA patients with a history of previous treatment with adalimumab
  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: NCT01346488

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

Additional Information:
Publications:
A Large-Scale Prospective Single Cohort Observational Study of Work Productivity and Activity Impairment In Japanese Patients With Rheumatoid Arthritis Receiving Adalimumab: The Final Analysis of 48-Week Data From the ANOUVEAU Study. EULAR2016 (9 June 2016), poster no. THU0159.
Economic Impact of Adalimumab Treatment in Japanese Patients with Rheumatoid Arthritis from the ANOUVEAU Study. ACR2016 (13 November 2016), poster no. 609

Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01346488     History of Changes
Other Study ID Numbers: P12-772
Study First Received: April 29, 2011
Results First Received: January 12, 2017
Last Updated: March 16, 2017

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
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 22, 2017