Rheumatoid Arthritis
Conditions
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.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Rheumatoid Arthritis-Work Instability Scale (RA-WIS) | 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 | From Month 0 to Month 6 | This is patient reported assessment of financial burden of RA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient pain | From Month 0 to Month 24 | Pain is assessed using Visual Analogue Scale (VAS) |
| Change in Tender Joint Count (TJC) | From Month 0 to Month 24 | This is assessed by the physician. |
| Change in Disease Activity Score (DAS) 28 | From Month 0 to Month 24 | Disease activity assessment is done by the physician. |
| Change in patient assessment of Global Disease Activity | From Month 0 to Month 24 | It is assessed using VAS. |
| Change in Swollen Joint Count (SJC) | From Month 0 to Month 24 | This is assessed by the physician. |
| Change in physician's assessment of Global Disease Activity | From Month 0 to Month 24 | It is assessed using VAS. |
| Change in Health Assessment Questionnaire (HAQ) | From Month 0 to Month 24 | This is patient reported functional assessment. |
| Change in Rheumatoid Arthritis-Work Instability (RA-WIS) | 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. |
| Rate of Remission per Disease Activity Scale (DAS) 28 | 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 | 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) | 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 | 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) | 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 | 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. |
| Change in c-reactive protein (CRP)/erythrocyte sedimentation rate (ESR) | From Month 0 to Month 24 | CRP/ESR values are measured as an inflammatory parameter. Low CRP and ESR values mean less inflammation. |
| Change in the Financial Loss | From Month 0 to Month 12, 18 and 24 | This is patient reported assessment of financial burden of RA. |
Countries
Canada
Outcome results
None listed