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

Completed

Conditions: Rheumatoid Arthritis

Registration Number: NCT01346488

Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2088

Inclusion Criteria

RA patients treated with adalimumab who satisfied the following conditions:

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

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score	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.
Change From Baseline in WPAI Questionnaire: Mean Percentage of Activity Impairment Due to RA	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 Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism)	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)	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	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.
Number of Participants Per Category of the HAQ-DI	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

Name	Time	Method
Number of Participants Per Category of the DAS28-4 CRP	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).
Number of Participants Per Category of the CDAI	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).
Number of Participants Per Category of the DAS28-4 ESR	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 Disease Activity Score 28-4 C-Reactive Protein (DAS 28-4 CRP)	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.
Change From Baseline in Clinical Disease Activity Index (CDAI)	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.
Change From Baseline in European Quality of Life-5 Dimensions Questionnaire (EQ-5D) Summary Index Score	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.
Change From Baseline in DAS28-4 Erythrocyte Sedimentation Rate (ESR)	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 With Adverse Events (AEs), Serious AEs (SAEs), and Deaths	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	up to Week 52	Adverse drug reactions were defined as AEs of which a causal relationship with adalimumab could not be ruled out.