Progress at Work - The Impact of Adalimumab on Work Related Productivity in Patients With Rheumatoid Arthritis (P @ Work)
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| ClinicalTrials.gov Identifier: NCT02362074 |
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Recruitment Status :
Completed
First Posted : February 12, 2015
Last Update Posted : February 11, 2021
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Sponsor:
AbbVie
Information provided by (Responsible Party):
AbbVie
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Brief Summary:
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.
| Condition or disease |
|---|
| Rheumatoid Arthritis |
| Study Type : | Observational |
| Actual Enrollment : | 401 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Progress at Work - The Impact of Adalimumab on Work Related Productivity in Patients With Rheumatoid Arthritis. |
| Actual Study Start Date : | January 21, 2015 |
| Actual Primary Completion Date : | March 6, 2020 |
| Actual Study Completion Date : | March 6, 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Rheumatoid arthritis
Drug Information available for:
Adalimumab
| Group/Cohort |
|---|
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Adalimumab subjects
Subjects starting Adalimumab treatment at time of enrollment.
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Primary Outcome Measures :
- 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.
- Change in Financial Loss [ Time Frame: From Month 0 to Month 6 ]This is patient reported assessment of financial burden of RA.
Secondary Outcome Measures :
- 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.
- 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.
- Change in patient pain [ Time Frame: From Month 0 to Month 24 ]Pain is assessed using Visual Analogue Scale (VAS)
- Change in Tender Joint Count (TJC) [ Time Frame: From Month 0 to Month 24 ]This is assessed by the physician.
- Change in Disease Activity Score (DAS) 28 [ Time Frame: From Month 0 to Month 24 ]Disease activity assessment is done by the physician.
- Change in patient assessment of Global Disease Activity [ Time Frame: From Month 0 to Month 24 ]It is assessed using VAS.
- Change in Swollen Joint Count (SJC) [ Time Frame: From Month 0 to Month 24 ]This is assessed by the physician.
- Change in physician's assessment of Global Disease Activity [ Time Frame: From Month 0 to Month 24 ]It is assessed using VAS.
- Change in Health Assessment Questionnaire (HAQ) [ Time Frame: From Month 0 to Month 24 ]This is patient reported functional assessment.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
This is a Multi-Center Canadian Observational Study that will enroll rheumatoid arthristis (RA) subjects for whom the treating physician has decided to treat with adalimumab.
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02362074
Locations
Show 32 study locations
Sponsors and Collaborators
AbbVie
Investigators
| Study Director: | AbbVie Inc. | AbbVie |
Additional Information:
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT02362074 |
| Other Study ID Numbers: |
P14-455 |
| First Posted: | February 12, 2015 Key Record Dates |
| Last Update Posted: | February 11, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Additional relevant MeSH terms:
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Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |