Clinical trial NCT01346488: Special Investigation in Patients With Rheumatoid Arthritis (Working Productivity Activity Impairment)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2011-05-03
Enrollment: 2088
Sex: ALL
Minimum age (years): 15
Maximum age (years): 87
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Single-arm, Multi-center, Prospective Cohort

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.

Eligibility 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

Primary outcomes:
measure: Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism)
timeFrame: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of adalimumab (ADA) therapy, and at final assessment (up to Week 48)
measure: Change From Baseline in WPAI Questionnaire: Mean Percentage of Impairment While Working Due to RA (Presenteeism)
timeFrame: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and at final assessment (up to Week 48)
measure: Change From Baseline in WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to RA
timeFrame: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and at final assessment (up to Week 48)
measure: Change From Baseline in WPAI Questionnaire: Mean Percentage of Activity Impairment Due to RA
timeFrame: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)
measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score
timeFrame: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)
measure: Number of Participants Per Category of the HAQ-DI
timeFrame: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)
Secondary outcomes:
measure: Change From Baseline in Disease Activity Score 28-4 C-Reactive Protein (DAS 28-4 CRP)
timeFrame: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)
measure: Number of Participants Per Category of the DAS28-4 CRP
timeFrame: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)
measure: Change From Baseline in DAS28-4 Erythrocyte Sedimentation Rate (ESR)
timeFrame: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)
measure: Number of Participants Per Category of the DAS28-4 ESR
timeFrame: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)
measure: Change From Baseline in Clinical Disease Activity Index (CDAI)
timeFrame: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)
measure: Number of Participants Per Category of the CDAI
timeFrame: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)
measure: Change From Baseline in European Quality of Life-5 Dimensions Questionnaire (EQ-5D) Summary Index Score
timeFrame: Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)
measure: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and Deaths
timeFrame: up to Week 52
measure: Number of Participants With Adverse Drug Reactions
timeFrame: up to Week 52
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Sarina Kurimoto, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.