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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rheumatoid Arthritis (RA)

• Study Type: Observational
• Enrollment (Estimated): 390

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5M 0H4
      • Rheumatology Research Associates /ID# 224534
    • Edmonton, Alberta, Canada, T6G 0T2
      • Saurash Reddy Professional Corporation /ID# 225288
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 3W4
      • Fraser Clinical Trials Inc /ID# 225200
    • Vancouver, British Columbia, Canada, V5Z 1J9
      • Dr. Jonathan D. Chan Inc. /ID# 222976
    • Victoria, British Columbia, Canada, V8P 5P6
      • Dr. Milton F. Baker Inc. /ID# 224555
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1M3
      • Manitoba Clinic /ID# 223288
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
      • Eastern Regional Health Authority /ID# 223911
    • St. John's, Newfoundland and Labrador, Canada, A1B 5E8
      • Nexus Clinical Research /ID# 225896
  • Nova Scotia
    • Sydney, Nova Scotia, Canada, B1S 3N1
      • Dr. Juris Lazovskis Inc. /ID# 224817
  • Ontario
    • Ancaster, Ontario, Canada, L9G 3K9
      • Dr. Viktoria Pavlova Medicine Professional Corporation /ID# 224536
    • Barrie, Ontario, Canada, L4M 6L2
      • The Waterside Clinic /ID# 224205
    • Brampton, Ontario, Canada, L6R 0W3
      • Drs. Rai & Sekhon Medicine Professional Corporation /ID# 224366
    • Burlington, Ontario, Canada, L7R 2H3
      • Dr. Sankalp V. Bhavsar Medicine Professional Corporation /ID# 223952
    • Cambridge, Ontario, Canada, N1R 4S1
      • Paolo Pace Medicine Professional Corporation /ID# 234057
    • Dundas, Ontario, Canada, L9H 1B7
      • Dr. Chrisostomos Kouroukis & Dr. Pauline Boulos MPC /ID# 223814
    • Etobicoke, Ontario, Canada, M9C 5N2
      • Arthur Karasik Medicine Professional Corporation /ID# 225276
    • Hamilton, Ontario, Canada, L8N 1Y2
      • Adachi Medicine Prof. Corp /ID# 223872
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare /ID# 224042
    • Hamilton, Ontario, Canada, L9C 5N2
      • West Mountain Medical Center /ID# 222975
    • Mississauga, Ontario, Canada, L5A 3V8
      • Brandusa Florica Medicine Professional Corporation /ID# 222173
    • Mississauga, Ontario, Canada, L5M 2V8
      • Credit Valley Rheumatology /ID# 219226
    • Mississauga, Ontario, Canada, L5M 4N4
      • Imtiaz MS Khan Medicine Prof /ID# 225275
    • Niagara Falls, Ontario, Canada, L2E 6A6
      • Rajwinder S. Dhillon Medicine /ID# 224365
    • Oakville, Ontario, Canada, L6H 3P1
      • Makhzoum Medicine Professional Corporation /Id# 229629
    • Oakville, Ontario, Canada, L6M 1M1
      • Dr. S. Gill Medicine Professional Corporation /ID# 225238
    • Oshawa, Ontario, Canada, L1H 1B9
      • Dr. L. Lisnevskaia Medicine Professional Corporation /ID# 225645
    • Ottawa, Ontario, Canada, K1H 7X3
      • Angela Montgomery Medicine Professional Corporation /ID# 231142
    • St. Catharines, Ontario, Canada, L2N 7E4
      • Niagara Peninsula Arthritis Ct /ID# 221472
    • Windsor, Ontario, Canada, N8X 1T3
      • Dr. Sabeen Anwar Medicine Professional Corporation /ID# 224797
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 225021
    • Montreal, Quebec, Canada, H2L 1S6
      • Rheumatology Institute of Montreal /ID# 224045
    • Montreal, Quebec, Canada, H4N 1C6
      • Clinique de Rhumatologie de Montreal /ID# 221266
    • Montréal, Quebec, Canada, H4A 3T2
      • Applied Medical Informatics Research Inc. (AMIR) /ID# 224321
    • Rimouski, Quebec, Canada, G5L 5T1
      • CISSSBSL -Hopital regional de Rimouski /ID# 224681
    • Sainte-foy, Quebec, Canada, G1V 3M7
      • Groupe de Recherche en Maladies Osseuses Inc /ID# 222977
    • Sherbrooke, Quebec, Canada, J1G 2E8
      • CIUSSS de l'Estrie - CHUS /ID# 225404
    • Trois-rivières, Quebec, Canada, G8Z 1Y2
      • Centre de Recherche Musculo-Squelettique /ID# 224513
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7H 5M7
      • Dr. Latha Naik /ID# 221195
    • Saskatoon, Saskatchewan, Canada, S7K 0H6
      • Rheumatology Associates /ID# 228584

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants receiving Upadacitinib according to the product prescribing information, for moderate to severe active Rheumatoid Arthritis (RA).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants receiving Upadacitinib; Participants receiving Upadacitinib for moderate to severe rheumatoid arthritis (RA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info.

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2020
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; Upadacitinib; RINVOQ
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: P20-096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No