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Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. This study will assess how effective Upadacitinib is in changing the disease symptoms in Canadian participants with RA.
Upadacitinib is a drug approved for the treatment of moderately to severely active rheumatoid arthritis. Adult Canadian participants with moderate to severe RA who have been prescribed upadacitinib by their physicians will be enrolled. Approximately, 390 participants will be enrolled this study, in multiple sites within Canada.
Participants will receive Upadacitinib as prescribed by the physician and will be followed for approximately 24 months.
There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving Upadacitinib | Participants receiving Upadacitinib for moderate to severe rheumatoid arthritis (RA). |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve Clinical Remission | Clinical remission is defined as Disease Activity Score at 28 joints (DAS28) C-reactive Protein (CRP)<2.6. | At Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Using Visual Analogue Scale (VAS) | Pain is defined using VAS, where a higher score indicates worse pain. | Baseline (Month 0) Through Month 24 |
| Duration of Morning Stiffness | Duration of morning joint stiffness is defined using VAS, where a higher score indicates worse joint stiffness. |
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Inclusion Criteria:
Diagnosis of moderate to severe Rheumatoid Arthritis (RA) according to the investigator.
Decision to initiate UPA treatment by investigator according to the local product label independent of the participant's participation in the study.
Has been previously treated with Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) and corresponds to one of the following subgroups:
Exclusion Criteria:
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Participants receiving Upadacitinib according to the product prescribing information, for moderate to severe active Rheumatoid Arthritis (RA).
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology Research Associates /ID# 224534 | Edmonton | Alberta | T5M 0H4 | Canada | ||
| Saurash Reddy Professional Corporation /ID# 225288 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38467912 | Derived | Bessette L, Chan J, Chow A, Lisnevskaia L, Richard N, Fournier PA, Liazoghli D, Girard T, Haaland D. Real-World Effectiveness of Upadacitinib for Treatment of Rheumatoid Arthritis in Canadian Patients: Interim Results from the Prospective Observational CLOSE-UP Study. Rheumatol Ther. 2024 Jun;11(3):563-582. doi: 10.1007/s40744-024-00651-8. Epub 2024 Mar 11. |
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| Baseline (Month 0) Through Month 24 |
| Severity of Morning Stiffness | Severity of morning joint stiffness is defined using VAS, where a higher score indicates worse joint stiffness. | Baseline (Month 0) Through Month 24 |
| Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) | The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four-point Likert scale (0 = not at all fatigued to 4 = very much fatigued). | Baseline (Month 0) Through Month 24 |
| Percentage of Participants Achieving Clinical Remission | Clinical Remission is defined as DAS28-CRP<2.6, Simplified Disease Activity Index (SDAI) ≤3.3, Clinical Disease Activity Index (CDAI) ≤2.8, American College of Rheumatology (ACR)-European League Against Rheumatism (EULAR) Boolean remission. | Baseline (Month 0) Through Month 24 |
| Percentage of Participants Achieving Low Disease Activity (LDA) | LDA is defined as DAS28-CRP<3.2, SDAI ≤11, CDAI ≤10. | Baseline (Month 0) Through Month 24 |
| Earliest Date When a Response to Treatment is Known to Have Occurred | Earliest date when a response to treatment is known to have occurred. | Baseline (Month 0) Through Month 24 |
| Earliest Date When Their RA is Known to have Returned (In those Participants who Achieve a Response to Treatment) | Earliest date when their RA is known to have returned (In those participants who achieve a response to treatment). | Through Month 24 |
| Change in DAS28-CRP Score | The DAS28-CRP used to evaluate disease activity in participants with RA, where worsening RA activity is defined by a higher score. | Baseline (Month 0) Through Month 24 |
| Change in CDAI Score | The CDAI is used to evaluate disease activity in participants with RA , where worsening RA activity is defined by a higher score. | Baseline (Month 0) Through Month 24 |
| Change in Tender Joint Count | Change in Tender Joint Count. | Baseline (Month 0) Through Month 24 |
| Change in Swollen Joint Count | Change in Swollen Joint Count. | Baseline (Month 0) Through Month 24 |
| Change in Physical Function (HAQ-DI) Score | The HAQ DI is a questionnaire that determines physical function. | Baseline (Month 0) Through Month 24 |
| Change in Patient Assessment of Global Disease Activity (PtGA) | The PtGA is a outcome instrument to assess the participant's assessment of disease severity. | Baseline (Month 0) Through Month 24 |
| Change in Physician Assessment of Global Disease Activity (PGA) | The PGA is a outcome instrument to assess the participant's assessment of disease severity. | Baseline (Month 0) Through Month 24 |
| Percentage of Participants Who Discontinue Upadacitinib | Percentage of participants who discontinue Upadacitinib. | Through Month 24 |
| Time of Discontinuation from Upadacitinib Initiation Date | Time of discontinuation from Upadacitinib initiation date. | Through Month 24 |
| Reasons for Upadacitinib Treatment Discontinuation | Reasons for Upadacitinib treatment discontinuation. | Through Month 24 |
| Immediate Change in RA Medications Following Discontinuation of Upadacitinib | Immediate change in RA medications following discontinuation of Upadacitinib. | Through Month 24 |
| Percentage of Participants Who Achieve Sustained Remission Following Discontinuation of Upadacitinib | Clinical remission is defined as DAS28 and CRP<2.6. | Through Month 24 |
| Edmonton |
| Alberta |
| T6G 0T2 |
| Canada |
| Fraser Clinical Trials Inc /ID# 225200 | New Westminster | British Columbia | V3L 3W4 | Canada |
| Dr. Jonathan D. Chan Inc. /ID# 222976 | Vancouver | British Columbia | V5Z 1J9 | Canada |
| Dr. Milton F. Baker Inc. /ID# 224555 | Victoria | British Columbia | V8P 5P6 | Canada |
| Manitoba Clinic /ID# 223288 | Winnipeg | Manitoba | R3A 1M3 | Canada |
| Eastern Regional Health Authority /ID# 223911 | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Nexus Clinical Research /ID# 225896 | St. John's | Newfoundland and Labrador | A1B 5E8 | Canada |
| Dr. Juris Lazovskis Inc. /ID# 224817 | Sydney | Nova Scotia | B1S 3N1 | Canada |
| Dr. Viktoria Pavlova Medicine Professional Corporation /ID# 224536 | Ancaster | Ontario | L9G 3K9 | Canada |
| Drs. Rai & Sekhon Medicine Professional Corporation /ID# 224366 | Brampton | Ontario | L6R 0W3 | Canada |
| Dr. Sankalp V. Bhavsar Medicine Professional Corporation /ID# 223952 | Burlington | Ontario | L7R 2H3 | Canada |
| Paolo Pace Medicine Professional Corporation /ID# 234057 | Cambridge | Ontario | N1R 4S1 | Canada |
| Dr. Chrisostomos Kouroukis & Dr. Pauline Boulos MPC /ID# 223814 | Dundas | Ontario | L9H 1B7 | Canada |
| Arthur Karasik Medicine Professional Corporation /ID# 225276 | Etobicoke | Ontario | M9C 5N2 | Canada |
| Adachi Medicine Prof. Corp /ID# 223872 | Hamilton | Ontario | L8N 1Y2 | Canada |
| St. Joseph's Healthcare /ID# 224042 | Hamilton | Ontario | L8N 4A6 | Canada |
| West Mountain Medical Center /ID# 222975 | Hamilton | Ontario | L9C 5N2 | Canada |
| Brandusa Florica Medicine Professional Corporation /ID# 222173 | Mississauga | Ontario | L5A 3V8 | Canada |
| Credit Valley Rheumatology /ID# 219226 | Mississauga | Ontario | L5M 2V8 | Canada |
| Imtiaz MS Khan Medicine Prof /ID# 225275 | Mississauga | Ontario | L5M 4N4 | Canada |
| Rajwinder S. Dhillon Medicine /ID# 224365 | Niagara Falls | Ontario | L2E 6A6 | Canada |
| Makhzoum Medicine Professional Corporation /Id# 229629 | Oakville | Ontario | L6H 3P1 | Canada |
| Dr. S. Gill Medicine Professional Corporation /ID# 225238 | Oakville | Ontario | L6M 1M1 | Canada |
| The Waterside Clinic /ID# 224205 | Orillia | Ontario | L3V 1T5 | Canada |
| Dr. L. Lisnevskaia Medicine Professional Corporation /ID# 225645 | Oshawa | Ontario | L1H 1B9 | Canada |
| Angela Montgomery Medicine Professional Corporation /ID# 231142 | Ottawa | Ontario | K1H 7X3 | Canada |
| Niagara Peninsula Arthritis Ct /ID# 221472 | St. Catharines | Ontario | L2N 7E4 | Canada |
| Dr. Sabeen Anwar Medicine Professional Corporation /ID# 224797 | Windsor | Ontario | N8X 1T3 | Canada |
| CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 225021 | Montreal | Quebec | H1T 2M4 | Canada |
| Rheumatology Institute of Montreal /ID# 224045 | Montreal | Quebec | H2L 1S6 | Canada |
| Applied Medical Informatics Research Inc. (AMIR) /ID# 224321 | Montreal | Quebec | H4A 3T2 | Canada |
| Clinique de Rhumatologie de Montreal /ID# 221266 | Montreal | Quebec | H4N 1C6 | Canada |
| CISSSBSL -Hopital regional de Rimouski /ID# 224681 | Rimouski | Quebec | G5L 5T1 | Canada |
| Groupe de Recherche en Maladies Osseuses Inc /ID# 222977 | Sainte-Foy | Quebec | G1V 3M7 | Canada |
| CIUSSS de l'Estrie - CHUS /ID# 225404 | Sherbrooke | Quebec | J1G 2E8 | Canada |
| Centre de Recherche Musculo-Squelettique /ID# 224513 | Trois-Rivières | Quebec | G8Z 1Y2 | Canada |
| Dr Naik-Medical Professional Corporation-Alliance Health /ID# 221195 | Saskatoon | Saskatchewan | S7H 5M7 | Canada |
| Rheumatology Associates /ID# 228584 | 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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