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

AbbVie

Status: Completed

Conditions: Rheumatoid Arthritis (RA)

Study type: Observational

Funder types: Industry

Identifiers

NCT04574492

P20-096

Details and patient eligibility

About

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.

Enrollment: 413 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

413 participants in 1 patient group

Participants receiving Upadacitinib

Description:

Participants receiving Upadacitinib for moderate to severe rheumatoid arthritis (RA).