N/A N=1,968

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

Rheumatoid Arthritis

Bottom Line

View on ClinicalTrials.gov: NCT01346488 ↗

Enrolled (actual)

1,968

Serious AEs

5.2%

Results posted

Mar 2017

Primary outcome: Primary: Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) — 7.23; 3.80; 3.73; 3.85 percentage of work time missed — p=< 0.0001

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Pediatric, Adult, Older Adult · 15+ yrs
Sex: All
Sponsor: AbbVie (prior sponsor, Abbott)
Primary completion: Jan 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism)	7.23; 3.80; 3.73; 3.85; 4.48; 1.25	< 0.0001 sig
PRIMARY Change From Baseline in WPAI Questionnaire: Mean Percentage of Impairment While Working Due to RA (Presenteeism)	39.60; 17.18; 20.20; 22.18; 23.32; 7.64	< 0.0001 sig
PRIMARY Change From Baseline in WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to RA	41.06; 17.08; 20.83; 22.31; 24.40; 6.30	<0.0001 sig
PRIMARY Change From Baseline in WPAI Questionnaire: Mean Percentage of Activity Impairment Due to RA	48.42; 19.42; 23.30; 25.53; 26.33; 11.42	< 0.0001 sig
PRIMARY Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score	0.93; 0.34; 0.41; 0.42; 0.44; 0.21	< 0.0001 sig
PRIMARY Number of Participants Per Category of the HAQ-DI	326; 253; 416; 411; 189; 135	<0.0001 sig
SECONDARY Change From Baseline in Disease Activity Score 28-4 C-Reactive Protein (DAS 28-4 CRP)	4.20; 1.55; 1.81; 1.91; 2.01; 0.91	< 0.0001 sig
SECONDARY Number of Participants Per Category of the DAS28-4 CRP	402; 911; 199; 177; 65; 356	< 0.0001 sig
SECONDARY Change From Baseline in DAS28-4 Erythrocyte Sedimentation Rate (ESR)	4.76; 1.61; 1.91; 2.01; 2.08; 0.97	< 0.0001 sig
SECONDARY Number of Participants Per Category of the DAS28-4 ESR	564; 662; 101; 76; 113; 437	< 0.0001 sig
SECONDARY Change From Baseline in Clinical Disease Activity Index (CDAI)	21.44; 11.98; 13.93; 14.26; 14.63; 8.00	< 0.0001 sig
SECONDARY Number of Participants Per Category of the CDAI	677; 749; 249; 21; 128; 374	< 0.0001 sig
SECONDARY Change From Baseline in European Quality of Life-5 Dimensions Questionnaire (EQ-5D) Summary Index Score	0.6295; -0.1112; -0.1380; -0.1574; -0.1541; -0.0597	< 0.0001 sig
SECONDARY Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and Deaths	475; 103; 5	—
SECONDARY Number of Participants With Adverse Drug Reactions	451	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01346488). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.