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Completed

NCT Number: NCT02362074

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pont, Cranbrook, BC, CA /ID# 134511, Cranbrook, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with moderate to severe RA for whom the physician has decided to initiate treatment with adalimumab
  • Adult male or female ≥ 18 years old that has been newly prescribed adalimumab therapy according to the local product label and are with PROGRESS
  • Subjects should be evaluated for tuberculosis (TB) exposure/risk factors for active and latent TB
  • Subject is able to give written patient authorization and is willing to comply with the requirements of this study protocol.

Exclusion criteria

  • Subject cannot or will not sign a patient authorization
  • Subject with a known hypersensitivity to Adalimumab, or any of its components
  • 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
  • Subjects currently participating in an investigational clinical trial
  • Subjects treated with >1 prior biologic disease-modifying antirheumatic drugs (DMARDs) for RA. Any prior treatment with adalimumab is prohibited
  • Subjects previously treated with targeted synthetic disease modifying agent.

Treatment and study plan

Primary outcomes

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

    Time frame: From Month 0 to Month 6

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

  2. Change in Financial Loss

    Time frame: From Month 0 to Month 6

    This is patient reported assessment of financial burden of RA.

Secondary outcomes

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

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

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

  2. Change in the Financial Loss

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

    This is patient reported assessment of financial burden of RA.

  3. Change in patient pain

    Time frame: From Month 0 to Month 24

    Pain is assessed using Visual Analogue Scale (VAS)

  4. Change in Tender Joint Count (TJC)

    Time frame: From Month 0 to Month 24

    This is assessed by the physician.

  5. Change in Disease Activity Score (DAS) 28

    Time frame: From Month 0 to Month 24

    Disease activity assessment is done by the physician.

  6. Change in patient assessment of Global Disease Activity

    Time frame: From Month 0 to Month 24

    It is assessed using VAS.

  7. Change in Swollen Joint Count (SJC)

    Time frame: From Month 0 to Month 24

    This is assessed by the physician.

  8. Change in physician's assessment of Global Disease Activity

    Time frame: From Month 0 to Month 24

    It is assessed using VAS.

  9. Change in Health Assessment Questionnaire (HAQ)

    Time frame: From Month 0 to Month 24

    This is patient reported functional assessment.

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

    Time frame: From Month 0 to Month 24

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

  11. Rate of Remission per Disease Activity Scale (DAS) 28

    Time frame: From Month 0 to Month 24

    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.

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

    Time frame: From Month 0 to Month 24

    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.

  13. Rate of Remission Per Clinical Disease Activity Index (CDAI)

    Time frame: From Month 0 to Month 24

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

  14. Rate of Achieving Low Disease Activity (LDA) per CDAI

    Time frame: From Month 0 to Month 24

    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.

  15. Rate of Remission per Simplified Disease Activity Index (SDAI)

    Time frame: From Month 0 to Month 24

    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.

  16. Rate of Achieving Low Disease Activity (LDA) per SDAI

    Time frame: From Month 0 to Month 24

    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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Acronym: P @ Work

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Feb 12, 2015
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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