Progress at Work - The Impact of Adalimumab on Work Related Productivity in Patients With Rheumatoid Arthritis

N/ACompletedNCT02362074

AbbVie401 enrolled

Overview

The purpose of this study is to describe the impact of treatment with adalimumab on work related productivity and economic burden in patients with Rheumatoid Arthritis (RA) treated in Canada.

Study Type

OBSERVATIONAL

Enrollment

401

Conditions

Rheumatoid Arthritis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects with moderate to severe RA for whom the physician has decided to initiate treatment with adalimumab 2. Adult male or female ≥ 18 years old that has been newly prescribed adalimumab therapy according to the local product label and are with PROGRESS 3. Subjects should be evaluated for tuberculosis (TB) exposure/risk factors for active and latent TB 4. Subject is able to give written patient authorization and is willing to comply with the requirements of this study protocol. Exclusion Criteria: 1. Subject cannot or will not sign a patient authorization 2. Subject with a known hypersensitivity to Adalimumab, or any of its components 3. Presence of any condition that, in the opinion of the treating physician, prohibits the subject from participating in the study or obscures the assessment of the treatment of RA 4. Subjects currently participating in an investigational clinical trial 5. Subjects treated with \>1 prior biologic disease-modifying antirheumatic drugs (DMARDs) for RA. Any prior treatment with adalimumab is prohibited 6. Subjects previously treated with targeted synthetic disease modifying agent.

Locations (32)

Outcomes

Primary Outcomes

Change in Rheumatoid Arthritis-Work Instability Scale (RA-WIS)

This is patient-reported assessment on the impact of adalimumab on the work status of RA patients.

Time frame: From Month 0 to Month 6

Change in Financial Loss

This is patient reported assessment of financial burden of RA.

Time frame: From Month 0 to Month 6

Secondary Outcomes

Change in Rheumatoid Arthritis-Work Instability (RA-WIS)

This is patient-reported assessment on the impact of adalimumab on the work status of RA patients.

Time frame: From Month 0 to Month 12, 18 and 24

Change in the Financial Loss

This is patient reported assessment of financial burden of RA.

Time frame: From Month 0 to Month 12, 18 and 24

Change in patient pain

Pain is assessed using Visual Analogue Scale (VAS)

Time frame: From Month 0 to Month 24

Change in Tender Joint Count (TJC)

This is assessed by the physician.

Time frame: From Month 0 to Month 24

Change in Disease Activity Score (DAS) 28

Disease activity assessment is done by the physician.

Time frame: From Month 0 to Month 24

Change in patient assessment of Global Disease Activity

It is assessed using VAS.

Data from ClinicalTrials.gov

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Pont, Cranbrook, BC, CA /ID# 134511

Cranbrook, British Columbia, Canada

Drs. M & W Teo Inc. /ID# 148641

Penticton, British Columbia, Canada

The Arthritis Research Center /ID# 147466

Vancouver, British Columbia, Canada

Kur, Vancouver, CA /ID# 135371

Vancouver, British Columbia, Canada

Manitoba Clinic /ID# 134830

Winnipeg, Manitoba, Canada

Nexus Clinical Research /ID# 135411

St. John's, Newfoundland and Labrador, Canada

St. Clare's Mercy Hospital /ID# 136737

St. John's, Newfoundland and Labrador, Canada

Dr. Juris Lazovskis Inc. /ID# 134510

Sydney, Nova Scotia, Canada

Waterside Clinique /ID# 134190

Barrie, Ontario, Canada

Drs Nalin and Vandana Ahluwali /ID# 136485

Brampton, Ontario, Canada

...and 22 more locations

Time frame: From Month 0 to Month 24

Change in Swollen Joint Count (SJC)

This is assessed by the physician.

Time frame: From Month 0 to Month 24

Change in physician's assessment of Global Disease Activity

It is assessed using VAS.

Time frame: From Month 0 to Month 24

Change in Health Assessment Questionnaire (HAQ)

This is patient reported functional assessment.

Time frame: From Month 0 to Month 24

Change in c-reactive protein (CRP)/erythrocyte sedimentation rate (ESR)

CRP/ESR values are measured as an inflammatory parameter. Low CRP and ESR values mean less inflammation.

Time frame: From Month 0 to Month 24

Rate of Remission per Disease Activity Scale (DAS) 28

The DAS28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 to 10. A DAS28 score less than 2.6 indicates clinical remission.

Time frame: From Month 0 to Month 24

Rate of Achieving Low Disease Activity (LDA) per Disease Activity Score (DAS) 28

The DAS28 is a validated index of rheumatoid arthritis disease activity. Scores range from 0 to 10 with LDA defined as a score from 2.6 to \< 3.2.

Time frame: From Month 0 to Month 24

Rate of Remission Per Clinical Disease Activity Index (CDAI)

The CDAI is used to evaluate disease activity in patients with Rheumatoid Arthritis.

Time frame: From Month 0 to Month 24

Rate of Achieving Low Disease Activity (LDA) per CDAI

The CDAI is a composite index for assessing disease activity. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10.

Time frame: From Month 0 to Month 24

Rate of Remission per Simplified Disease Activity Index (SDAI)

The SDAI is a validated measure of rheumatoid arthritis disease activity. Scores on the SDAI range from 0 to 86 with a SDAI score ≤3.3 indicating clinical remission.

Time frame: From Month 0 to Month 24

Rate of Achieving Low Disease Activity (LDA) per SDAI

The SDAI is a validated measure of rheumatoid arthritis disease activity. Scores on the SDAI range from 0 to 86 with a SDAI score \<11 indicating LDA.

Time frame: From Month 0 to Month 24