CLOSEUP

A Study of Oral Upadacitinib Tablets to Assess the Change in Disease Symptoms in Adult Canadian Participants With Moderate to Severe Rheumatoid Arthritis

Brief summary

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.

Observational study

Status:
Recruiting
Conditions:
Rheumatoid Arthritis (RA)
Enrollment:
390 patients
Protocol ID:
P20-096
Observational model:
Cohort
Time perspective:
Prospective

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Eligibility criteria

Participant attributes:
Male and Female

Age:

18 Years and older.

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:

- Has not been previously exposed to any Biologic Disease-Modifying Antirheumatic
Drugs (bDMARD) or Targeted Synthetic Disease-Modifying Antirheumatic Drugs
(tsDMARD).

- Has not been previously exposed to tsDMARD and has been previously exposed to <=
2 bDMARDs.

- Has been previously treated with one tsDMARD and <=1 bDMARD prior to treatment
with that tsDMARD.

Exclusion Criteria:

- Presence of any condition that, in the opinion of the treating physician, prohibits
the participant from participating in the study or obscures the assessment of the
treatment of RA.

- Diagnosis of rheumatic disease other than RA.

- Diagnosis of juvenile RA.

- Currently participating in an investigational clinical trial.

- Has prior exposure to a bDMARD after exposure to a tsDMARD.

- Has prior exposure to tsDMARD in an investigational clinical trial.

All the cities where the clinical studies are located

Edmonton - T5M 0H4
Edmonton - T6G 0T2
New Westminster - V3L 3W4
Vancouver - V5Z 1J9
Victoria - V8P 5P6
St. John's - A1B 5E8
St. John's - A1B 3V6
Sydney - B1S 3N1
Ancaster - L9G 3K9
Barrie - L4M 6L2
Brampton - L6R 0W3
Burlington - L7R 2H3
Dundas - L9H 1B7
Hamilton - L8N 1Y2
Hamilton - L8N 4A6
Hamilton - L9C 5N2
Mississauga - L5A 3V8
Mississauga - L5M 2V8
Mississauga - L5M 4N4
Niagara Falls - L2E 6A6
Oakville - L6H 3P1
Oakville - L6M 1M1
Oshawa - L1H 1B9
Ottawa - K1H 7X3
St. Catharines - L2N 7E4
Windsor - N8X 1T3
Montreal - H1T 2M4
Montreal - H2L 1S6
Montreal - H4N 1C6
Montréal - H4A 3T2
Rimouski - G5L 8W1
Sainte-foy - G1V 3M7
Sherbrooke - J1G 2E8
Trois-rivières - G8Z 1Y2
Saskatoon - S7K 0H6
Saskatoon - S7K 3H3
Winnipeg - R3A 1M3