Canadian Real-life Post-marketing Observational Study Assessing the Effectiveness of Upadacitinib for Treating Rheumatoid Arthritis (CLOSEUP)

AbbVie39 sites in 1 country413 target enrollmentOctober 7, 2020

ConditionsRheumatoid Arthritis (RA)

Overview

Phase: N/A
Intervention: Not specified
Conditions: Rheumatoid Arthritis (RA)
Sponsor: AbbVie
Enrollment: 413
Locations: 39
Primary Endpoint: Percentage of Participants Who Achieve Clinical Remission
Status: Completed
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 7, 2020

End Date

July 30, 2024

Last Updated

8 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AbbVie

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Percentage of Participants Who Achieve Clinical Remission

Time Frame: At Month 6

Clinical remission is defined as Disease Activity Score at 28 joints (DAS28) C-reactive Protein (CRP)\<2.6.

Secondary Outcomes

Change in DAS28-CRP Score(Baseline (Month 0) Through Month 24)
Change in Physician Assessment of Global Disease Activity (PGA)(Baseline (Month 0) Through Month 24)
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)(Baseline (Month 0) Through Month 24)
Percentage of Participants Achieving Clinical Remission(Baseline (Month 0) Through Month 24)
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)(Through Month 24)
Change in CDAI Score(Baseline (Month 0) Through Month 24)
Change in Swollen Joint Count(Baseline (Month 0) Through Month 24)
Change in Patient Assessment of Global Disease Activity (PtGA)(Baseline (Month 0) Through Month 24)
Change in Pain Using Visual Analogue Scale (VAS)(Baseline (Month 0) Through Month 24)
Severity of Morning Stiffness(Baseline (Month 0) Through Month 24)
Change in Physical Function (HAQ-DI) Score(Baseline (Month 0) Through Month 24)
Time of Discontinuation from Upadacitinib Initiation Date(Through Month 24)
Percentage of Participants Achieving Low Disease Activity (LDA)(Baseline (Month 0) Through Month 24)
Percentage of Participants Who Discontinue Upadacitinib(Through Month 24)
Reasons for Upadacitinib Treatment Discontinuation(Through Month 24)
Duration of Morning Stiffness(Baseline (Month 0) Through Month 24)
Change in Tender Joint Count(Baseline (Month 0) Through Month 24)
Percentage of Participants Who Achieve Sustained Remission Following Discontinuation of Upadacitinib(Through Month 24)
Immediate Change in RA Medications Following Discontinuation of Upadacitinib(Through Month 24)