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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab subjects | Subjects starting Adalimumab treatment at time of enrollment. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Month 0 to Month 6 |
| Change in Financial Loss | This is patient reported assessment of financial burden of RA. | From Month 0 to Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Month 0 to Month 12, 18 and 24 |
| Change in the Financial Loss |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pont, Cranbrook, BC, CA /ID# 134511 | Cranbrook | British Columbia | V1C 2R7 | Canada | ||
| Drs. M & W Teo Inc. /ID# 148641 |
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| Label | URL |
|---|---|
| clinical study report synopsis | View source |
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This is patient reported assessment of financial burden of RA.
| From Month 0 to Month 12, 18 and 24 |
| Change in patient pain | Pain is assessed using Visual Analogue Scale (VAS) | From Month 0 to Month 24 |
| Change in Tender Joint Count (TJC) | This is assessed by the physician. | From Month 0 to Month 24 |
| Change in Disease Activity Score (DAS) 28 | Disease activity assessment is done by the physician. | From Month 0 to Month 24 |
| Change in patient assessment of Global Disease Activity | It is assessed using VAS. | From Month 0 to Month 24 |
| Change in Swollen Joint Count (SJC) | This is assessed by the physician. | From Month 0 to Month 24 |
| Change in physician's assessment of Global Disease Activity | It is assessed using VAS. | From Month 0 to Month 24 |
| Change in Health Assessment Questionnaire (HAQ) | This is patient reported functional assessment. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From Month 0 to Month 24 |
| Penticton |
| British Columbia |
| V2A 4Z1 |
| Canada |
| The Arthritis Research Center /ID# 147466 | Vancouver | British Columbia | V5Z 1L7 | Canada |
| Kur, Vancouver, CA /ID# 135371 | Vancouver | British Columbia | V5Z 3Y1 | Canada |
| Manitoba Clinic /ID# 134830 | Winnipeg | Manitoba | R3A 1M3 | Canada |
| Nexus Clinical Research /ID# 135411 | St. John's | Newfoundland and Labrador | A1B 5E8 | Canada |
| St. Clare's Mercy Hospital /ID# 136737 | St. John's | Newfoundland and Labrador | A1C 5B8 | Canada |
| Dr. Juris Lazovskis Inc. /ID# 134510 | Sydney | Nova Scotia | B1S 3N1 | Canada |
| Waterside Clinique /ID# 134190 | Barrie | Ontario | L4M 6L2 | Canada |
| Drs Nalin and Vandana Ahluwali /ID# 136485 | Brampton | Ontario | L6T 0G1 | Canada |
| Dr. Sanjay Dixit Medicine Professional Corporation /ID# 136486 | Burlington | Ontario | L7L 0B7 | Canada |
| Dr. Chrisotomor Kouroukis & Dr /ID# 151189 | Dundas | Ontario | L9H 1B7 | Canada |
| Adachi Medicine Prof. Corp /ID# 152538 | Hamilton | Ontario | L8N 1Y2 | Canada |
| West Mountain Medical Center /ID# 134832 | Hamilton | Ontario | L9C 5N2 | Canada |
| Dr. Martin M.S. Lee Med Prof C /ID# 138333 | Mississauga | Ontario | L5A 1W4 | Canada |
| Brandusa Florica Med Prof Corp /ID# 134829 | Mississauga | Ontario | L5A 3V8 | Canada |
| Montgomery, Mississauga, CA /ID# 136943 | Mississauga | Ontario | L5A 3V8 | Canada |
| Credit Valley Rheumatology /ID# 134834 | Mississauga | Ontario | L5M 2V8 | Canada |
| Rajwinder S. Dhillon Medicine /ID# 147756 | Niagara Falls | Ontario | L2E 6A6 | Canada |
| Capital North Therapeutics Res /ID# 134835 | Ottawa | Ontario | K1Y 4G2 | Canada |
| Setty, Owen Sound, CA /ID# 134189 | Owen Sound | Ontario | N4K 1S4 | Canada |
| The Medical Centre /ID# 134833 | Peterborough | Ontario | K9J 7B3 | Canada |
| Involved Medicine /ID# 163880 | Toronto | Ontario | M3H 5S4 | Canada |
| Dr. Samuel K Silverberg /ID# 136496 | Toronto | Ontario | M9V 4B8 | Canada |
| Institut de Rhum. de Montreal /ID# 135289 | Montreal | Quebec | H2L 1S6 | Canada |
| Jewish General Hospital /ID# 204168 | Montreal | Quebec | H3T 1E2 | Canada |
| PSS Medical Inc. /ID# 134193 | Montreal | Quebec | H3T 1Y3 | Canada |
| Clinique de Rhumatologie de Montréal /ID# 162186 | Montreal | Quebec | H4N 1C6 | Canada |
| Ctr. de Rheum de l'est du QC /ID# 135410 | Rimouski | Quebec | G5L 8W1 | Canada |
| Rheum Disease Ctr of Montreal /ID# 135372 | Westmount | Quebec | H3Z 2Z3 | Canada |
| Dr. Latha Naik /ID# 135813 | Saskatoon | Saskatchewan | S7K 3H3 | Canada |
| Chuq - Chul /Id# 137054 | Québec | G1V 4G2 | Canada |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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