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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO148ARA4010 | Other Identifier | Janssen Inc. |
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The purpose of this study is to determine if non-adherence to Rheumatoid Arthritis (RA) drugs in participants treated with biologic disease modifying anti-rheumatic drugs (DMARDs) is associated with a greater incidence of disease in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Diagnosis of Rheumatoid Arthritis | Participants will not receive any intervention as a part of this study. All Rheumatoid Arthritis (RA) participants treated with golimumab in a clinical practice setting will be observed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Golimumab | Biological | Participants will receive golimumab as a part of clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Adherence on Flares as Assessed by Rheumatoid Arthritis Flare Questionnaire (RA-FQ) Score at 6 Month | Impact of adherence on flares will be assessed by RA-FQ score or the answer to question 7 of the RA-FQ (Are you having a flare?) at 6 month in participants categorized as "low predicted compliance" vs "high predicted compliance". RA-FQ is 10 point scale for questions 1 to 5, with score range from 0 to 10, where higher score indicates worse outcome and having option 'Yes' and 'No' for question 6 and 7. The RA-FQ total score is calculated as the sum of responses for items 1-5 (maximum 50). Higher score indicates worst outcome. | 6 Month |
| Impact of Adherence on Flares as Assessed by RA-FQ Score at 12 Month | Impact of adherence on flares will be assessed by RA-FQ score or the answer to question 7 of the RA-FQ (Are you having a flare?) at 12 month in participants categorized as "low predicted compliance" vs "high predicted compliance". RA-FQ is 10 point scale for questions 1 to 5, with score range from 0 to 10, where higher score indicates worse outcome and having option 'Yes' and 'No' for question 6 and 7. The RA-FQ total score is calculated as the sum of responses for items 1-5 (maximum 50). Higher score indicates worst outcome. | 12 Month |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Adherent Participants at 6 and 12 Months | Percentage of adherent participants at 6 and 12 Months will be assessed. | Months 6 and 12 |
| Number of Participants with Corticosteroid Use |
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Inclusion Criteria:
Exclusion Criteria:
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All Rheumatoid Arthritis (RA) participants treated with golimumab in a clinical practice setting will be observed.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Inc. Clinical Trial | Janssen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peak Medical Specialty Centre | Calgary | Alberta | T3B 0B2 | Canada | ||
| Jacqueline C Stewart Medical Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40585577 | Derived | Bessette L, Boulos P, Arendse R, Rahman P, Aseer S, Ruban T, Rachich M, Nantel F, Calce A, Asin-Milan O, Haaland D. Impact of Adherence to Golimumab on Disease Flares in Rheumatoid Arthritis: Results from a Canadian Observational Study. Patient Prefer Adherence. 2025 Jun 25;19:1843-1853. doi: 10.2147/PPA.S516794. eCollection 2025. |
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Number of participants with corticosteroid use will be assessed among participants categorized as "low predicted compliance" vs "high predicted compliance" at 6 and 12 months.
| Months 6 and 12 |
| Predicting Factors for Adherence | Independent predictors of "predicted compliance" will be assessed with univariate and multivariate Cox regression analysis. | Months 6 and 12 |
| Number of Participants with any Adverse Events (AEs), Serious Adverse Events (SAEs) or Discontinuation of Golimumab | Number of participants with any AEs, SAEs or discontinuation of golimumab will be assessed among participants categorized as "low predicted compliance" vs "high predicted compliance" at 6 and 12 months and include any such event up to the previous study visit. | Months 6 and 12 |
| Percentage of Participants with Response to Patient Support Program Question | Percentage of participants with response to Patient Support Program Question (Yes/No) will be assessed among participants categorized as "low predicted compliance" vs "high predicted compliance" at 6 and 12 months. | Months 6 and 12 |
| Penticton |
| British Columbia |
| V2A 3G7 |
| Canada |
| Dr. Milton F Baker Inc. | Victoria | British Columbia | V8P 5P6 | Canada |
| Fredericton Medical Clinic | Fredericton | New Brunswick | E3B 6H5 | Canada |
| Nexus Clinical Research | St. John's | Newfoundland and Labrador | A1A 5E8 | Canada |
| St Clare's Hospital | St. John's | Newfoundland and Labrador | A1C 2E9 | Canada |
| Private Practice - Dr. Diane Wilson | Lunenburg | Nova Scotia | B0J2C0 | Canada |
| The Waterside Clinic | Barrie | Ontario | L4M 6L2 | Canada |
| Dr. Sankalp V. Bhavsar Medicine Professional Corporation | Burlington | Ontario | L7R 2H3 | Canada |
| Private Practice - Dr. Pauline Boulos | Dundas | Ontario | L9H 1B7 | Canada |
| Dr. Sangeetha Thiviyarajah Medicine Professional Corporation | Etobicoke | Ontario | M9V 3Z7 | Canada |
| Samuel Silverberg Medicine Professional Corporation | Etobicoke | Ontario | M9V 5G5 | Canada |
| Adachi Medicine Professional Corporation | Hamilton | Ontario | L8N 1Y2 | Canada |
| Manisha Mulgund Medicine Professional Corporation | Hamilton | Ontario | L9C 5N2 | Canada |
| K-W Musculoskeletal Research Inc | Kitchener | Ontario | N2M 5N6 | Canada |
| Markham Rheumatology Hub | Markham | Ontario | L3R 2C7 | Canada |
| Credit Valley Rheumatology | Mississauga | Ontario | L5M 2V8 | Canada |
| Dr. Rajwinder S Dhillon Medicine Professional Corporation | Niagara Falls | Ontario | L2E 6A6 | Canada |
| Makhzoum Medicine Professional Coporation | Oakville | Ontario | L6H 3P1 | Canada |
| Dr. S. Gill Medicine Professional Corporation | Oakville | Ontario | L6M 1M1 | Canada |
| Dr. Abraham Chaiton Medicine Professional Corporation | Toronto | Ontario | M3N 2V6 | Canada |
| Sunnybrook Regional Cancer Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Arthur Karasik Medicine Professional Corporation | Toronto | Ontario | M6C 1Y8 | Canada |
| Dr. Sabeen Anwar Medicine Professional Corporation | Windsor | Ontario | N8X 1T3 | Canada |
| Clinique de Rhumatologie de Montreal | Montreal | Quebec | H4N 1C6 | Canada |
| Private Practice Dr Louis Bessette | Québec | Quebec | G1V 3M7 | Canada |
| Centre de sante et services sociaux (CSSS) de Rimouski-Neigette - Hopital regional - Rimouski | Rimouski | Quebec | G5L 5T1 | Canada |
| CIUSSS de L Estrie CHUS | Sherbrooke | Quebec | J1G 2E8 | Canada |
| Clinique Jacques Cartier- Rheumatology Division - Université de Sherbrooke | Sherbrooke | Quebec | J1J 2E3 | Canada |
| Centre de Recherche Musculo Squelettique | Trois-Rivières | Quebec | G8Z1Y2 | Canada |
| Community Rheumatology Care | Saskatoon | Saskatchewan | S7K 0H6 | Canada |
| Rheumatology Associates of Saskatoon | Saskatoon | Saskatchewan | S7K 0H6 | 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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| ID | Term |
|---|---|
| C529000 | golimumab |
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