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

An observational study of Rheumatoid Arthritis, run by AbbVie (prior sponsor, Abbott).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 15 to 87 years
Conditions the study is for: Rheumatoid Arthritis
How many people: 2,088 participants
Where: No sites listed yet
Study dates: Jun 2011to Jan 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 87 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Single-arm, Multi-center, Prospective Cohort

Who may be able to join

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

Who cannot join

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

About this study

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

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.

Read the 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.

Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01346488
Study group	Role	What they receive
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).

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism)
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.
Measured: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of adalimumab (ADA) therapy, and at final assessment (up to Week 48)
Change From Baseline in WPAI Questionnaire: Mean Percentage of Impairment While Working Due to RA (Presenteeism)
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.
Measured: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and at final assessment (up to Week 48)
Change From Baseline in WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to RA
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.
Measured: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and at final assessment (up to Week 48)
Change From Baseline in WPAI Questionnaire: Mean Percentage of Activity Impairment Due to RA
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.
Measured: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score
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.
Measured: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)
Number of Participants Per Category of the HAQ-DI
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).
Measured: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)

Secondary outcomes (9)

Change From Baseline in Disease Activity Score 28-4 C-Reactive Protein (DAS 28-4 CRP)
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.
Measured: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)
Number of Participants Per Category of the DAS28-4 CRP
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).
Measured: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)
Change From Baseline in DAS28-4 Erythrocyte Sedimentation Rate (ESR)
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.
Measured: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)
Number of Participants Per Category of the DAS28-4 ESR
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).
Measured: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)
Change From Baseline in Clinical Disease Activity Index (CDAI)
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.
Measured: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)
Number of Participants Per Category of the CDAI
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).
Measured: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)
Change From Baseline in European Quality of Life-5 Dimensions Questionnaire (EQ-5D) Summary Index Score
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.
Measured: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and Deaths
AEs, which were defined as any untoward medical occurrence observed in participants who received adalimumab in this study, were summarized.
Measured: up to Week 52
Number of Participants With Adverse Drug Reactions
Adverse drug reactions were defined as AEs of which a causal relationship with adalimumab could not be ruled out.
Measured: up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2011Jan 2016

First posted3 May 2011 (estimated)
Study startJun 2011
Primary completionJan 2016
Study completionJan 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 2,088 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01346488
Sponsor's protocol ID: P12-772
Status last verified: Mar 2017
First submitted: 29 Apr 2011
Last updated: 13 Apr 2017
Results posted: Yes, on ClinicalTrials.gov

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.
Tanaka Y, Yamazaki K, Nakajima R, Komatsu S, Igarashi A, Tango T, Takeuchi T. Economic impact of adalimumab treatment in Japanese patients with rheumatoid arthritis from the adalimumab non-interventional trial for up-verified effects and utility (ANOUVEAU) study. Mod Rheumatol. 2018 Jan;28(1):39-47. doi: 10.1080/14397595.2017.1341459. Epub 2017 Jul 13.
PubMed 28704126
Takeuchi T, Nakajima R, Komatsu S, Yamazaki K, Nakamura T, Agata N, Igarashi A, Tango T, Tanaka Y. Impact of Adalimumab on Work Productivity and Activity Impairment in Japanese Patients with Rheumatoid Arthritis: Large-Scale, Prospective, Single-Cohort ANOUVEAU Study. Adv Ther. 2017 Mar;34(3):686-702. doi: 10.1007/s12325-017-0477-z. Epub 2017 Jan 31.
PubMed 28144917

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
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An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01346488
Acronym / sponsor ID: P12-772
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Study type: Observational
Recruitment status: Completed
Enrolment: 2,088 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Jan 2016 (actual)
Study completion: Jan 2016 (actual)
First posted: 3 May 2011 (estimated)
Results: Posted 3 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
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).

Who may qualify

Ages: 15 to 87 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Single-arm, Multi-center, Prospective Cohort

Key inclusion criteria (5 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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).

9 secondary outcomes

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)
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)
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)
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)
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)
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)
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)
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and Deaths
Time frame: up to Week 52
Number of Participants With Adverse Drug Reactions
Time frame: up to Week 52

Results and safety

Results posted to the registry on 3 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants Receiving Adalimumab	1,968	1,262

Primary outcome: 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). Mean (Standard Deviation). Unit: percentage of work time missed

Measure	Participants Receiving Adalimumab n = 782
Baseline	7.23 (18.90)
Change at Week 12	3.80 (17.61)
Change at Week 24	3.73 (16.56)
Change at Week 36	3.85 (15.79)
Change at Week 48	4.48 (17.91)
Change at ADA discontinuation	1.25 (14.46)
Change at final assessment	4.23 (17.77)

Participants Receiving Adalimumab: p < 0.0001, Paired t-test
Participants Receiving Adalimumab: p < 0.0001, Paired t-test
Participants Receiving Adalimumab: p < 0.0001, Paired t-test

Population analysed: Participants with evaluable WPAI-RA assessments; number analyzed=participants with an evaluable assessment at given time point.

Primary outcome: 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). Mean (Standard Deviation). Unit: percentage of impairment while working

Measure	Participants Receiving Adalimumab n = 858
Baseline	39.60 (28.53)
Change at Week 12	17.18 (26.45)
Change at Week 24	20.20 (27.54)
Change at Week 36	22.18 (28.37)
Change at Week 48	23.32 (27.27)
Change at ADA discontinuation	7.64 (29.87)
Change at final assessment	19.30 (29.02)

Participants Receiving Adalimumab: p < 0.0001, Paired t-test
Participants Receiving Adalimumab: p < 0.0001, Paired t-test
Participants Receiving Adalimumab: p < 0.0001, Paired t-test

Population analysed: Participants with evaluable WPAI-RA assessments; number analyzed=participants with an evaluable assessment at given time point.

Primary outcome: 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). Mean (Standard Deviation). Unit: percentage of OWPI

Measure	Participants Receiving Adalimumab n = 771
Baseline	41.06 (29.58)
Change at Week 12	17.08 (27.60)
Change at Week 24	20.83 (28.83)
Change at Week 36	22.31 (29.42)
Change at Week 48	24.40 (28.37)
Change at ADA discontinuation	6.30 (29.60)
Change at final assessment	19.77 (29.99)

Participants Receiving Adalimumab: p <0.0001, Paired t-test
Participants Receiving Adalimumab: p <0.0001, Paired t-test
Participants Receiving Adalimumab: p < 0.0001, Paired t-test

Population analysed: Participants with evaluable WPAI-RA assessments; number analyzed=participants with an evaluable assessment at given time point.

Primary outcome: 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). Mean (Standard Deviation). Unit: percentage of activity impairment

Measure	Participants Receiving Adalimumab n = 1546
Baseline	48.42 (28.11)
Change at Week 12	19.42 (25.86)
Change at Week 24	23.30 (28.07)
Change at Week 36	25.53 (27.91)
Change at Week 48	26.33 (28.17)
Change at ADA discontinuation	11.42 (29.83)
Change at final assessment	22.36 (29.44)

Participants Receiving Adalimumab: p < 0.0001, Paired t-test
Participants Receiving Adalimumab: p <0.0001, Paired t-test
Participants Receiving Adalimumab: p <0.0001, Paired t-test

Population analysed: Participants with evaluable WPAI-RA assessments; number analyzed=participants with an evaluable assessment at given time point.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to Week 52. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants Receiving Adalimumab	103 of 1,968 (5.2%)	202 of 1,968 (10.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationA 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.
Results publication: PubMed 28704126Tanaka Y, Yamazaki K, Nakajima R, Komatsu S, Igarashi A, Tango T, Takeuchi T. Economic impact of adalimumab treatment in Japanese patients with rheumatoid arthritis from the adalimumab non-interventional trial for up-verified effects and utility (ANOUVEAU) study. Mod Rheumatol. 2018 Jan;28(1):39-47. doi: 10.1080/14397595.2017.1341459. Epub 2017 Jul 13.
Derived from this study: PubMed 28144917Takeuchi T, Nakajima R, Komatsu S, Yamazaki K, Nakamura T, Agata N, Igarashi A, Tango T, Tanaka Y. Impact of Adalimumab on Work Productivity and Activity Impairment in Japanese Patients with Rheumatoid Arthritis: Large-Scale, Prospective, Single-Cohort ANOUVEAU Study. Adv Ther. 2017 Mar;34(3):686-702. doi: 10.1007/s12325-017-0477-z. Epub 2017 Jan 31.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sarina Kurimoto, MD study director

AbbVie

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by AbbVie (prior sponsor, Abbott).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01346488, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.