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

Rheumatoid Arthritis (RA) Clinical Trial

— CLOSEUP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04574492
• Other study ID #: P20-096
• Status: Active, not recruiting
• Start date: October 7, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: July 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 390
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis (RA)

Locations

Country	Name	City	State
Canada	Dr. Viktoria Pavlova Medicine Professional Corporation /ID# 224536	Ancaster	Ontario
Canada	The Waterside Clinic /ID# 224205	Barrie	Ontario
Canada	Drs. Rai & Sekhon Medicine Professional Corporation /ID# 224366	Brampton	Ontario
Canada	Dr. Sankalp V. Bhavsar Medicine Professional Corporation /ID# 223952	Burlington	Ontario
Canada	Paolo Pace Medicine Professional Corporation /ID# 234057	Cambridge	Ontario
Canada	Dr. Chrisostomos Kouroukis & Dr. Pauline Boulos MPC /ID# 223814	Dundas	Ontario
Canada	Rheumatology Research Associates /ID# 224534	Edmonton	Alberta
Canada	Saurash Reddy Professional Corporation /ID# 225288	Edmonton	Alberta
Canada	Arthur Karasik Medicine Professional Corporation /ID# 225276	Etobicoke	Ontario
Canada	Adachi Medicine Prof. Corp /ID# 223872	Hamilton	Ontario
Canada	St. Joseph's Healthcare /ID# 224042	Hamilton	Ontario
Canada	West Mountain Medical Center /ID# 222975	Hamilton	Ontario
Canada	Brandusa Florica Medicine Professional Corporation /ID# 222173	Mississauga	Ontario
Canada	Credit Valley Rheumatology /ID# 219226	Mississauga	Ontario
Canada	Imtiaz MS Khan Medicine Prof /ID# 225275	Mississauga	Ontario
Canada	CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 225021	Montreal	Quebec
Canada	Clinique de Rhumatologie de Montreal /ID# 221266	Montreal	Quebec
Canada	Rheumatology Institute of Montreal /ID# 224045	Montreal	Quebec
Canada	Applied Medical Informatics Research Inc. (AMIR) /ID# 224321	Montréal	Quebec
Canada	Fraser Clinical Trials Inc /ID# 225200	New Westminster	British Columbia
Canada	Rajwinder S. Dhillon Medicine /ID# 224365	Niagara Falls	Ontario
Canada	Dr. S. Gill Medicine Professional Corporation /ID# 225238	Oakville	Ontario
Canada	Makhzoum Medicine Professional Corporation /Id# 229629	Oakville	Ontario
Canada	Dr. L. Lisnevskaia Medicine Professional Corporation /ID# 225645	Oshawa	Ontario
Canada	Angela Montgomery Medicine Professional Corporation /ID# 231142	Ottawa	Ontario
Canada	CISSSBSL -Hopital regional de Rimouski /ID# 224681	Rimouski	Quebec
Canada	Groupe de Recherche en Maladies Osseuses Inc /ID# 222977	Sainte-foy	Quebec
Canada	Dr. Latha Naik /ID# 221195	Saskatoon	Saskatchewan
Canada	Rheumatology Associates /ID# 228584	Saskatoon	Saskatchewan
Canada	CIUSSS de l'Estrie - CHUS /ID# 225404	Sherbrooke	Quebec
Canada	Niagara Peninsula Arthritis Ct /ID# 221472	St. Catharines	Ontario
Canada	Eastern Regional Health Authority /ID# 223911	St. John's	Newfoundland and Labrador
Canada	Nexus Clinical Research /ID# 225896	St. John's	Newfoundland and Labrador
Canada	Dr. Juris Lazovskis Inc. /ID# 224817	Sydney	Nova Scotia
Canada	Centre de Recherche Musculo-Squelettique /ID# 224513	Trois-rivières	Quebec
Canada	Dr. Jonathan D. Chan Inc. /ID# 222976	Vancouver	British Columbia
Canada	Dr. Milton F. Baker Inc. /ID# 224555	Victoria	British Columbia
Canada	Dr. Sabeen Anwar Medicine Professional Corporation /ID# 224797	Windsor	Ontario
Canada	Manitoba Clinic /ID# 223288	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Tender Joint Count	Change in Tender Joint Count.	Baseline (Month 0) Through Month 24
Secondary	Change in Swollen Joint Count	Change in Swollen Joint Count.	Baseline (Month 0) Through Month 24
Secondary	Change in Physical Function (HAQ-DI) Score	The HAQ DI is a questionnaire that determines physical function.	Baseline (Month 0) Through Month 24
Secondary	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
Secondary	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
Secondary	Percentage of Participants Who Discontinue Upadacitinib	Percentage of participants who discontinue Upadacitinib.	Through Month 24
Secondary	Time of Discontinuation from Upadacitinib Initiation Date	Time of discontinuation from Upadacitinib initiation date.	Through Month 24
Secondary	Reasons for Upadacitinib Treatment Discontinuation	Reasons for Upadacitinib treatment discontinuation.	Through Month 24
Secondary	Immediate Change in RA Medications Following Discontinuation of Upadacitinib	Immediate change in RA medications following discontinuation of Upadacitinib.	Through Month 24
Secondary	Percentage of Participants Who Achieve Sustained Remission Following Discontinuation of Upadacitinib	Clinical remission is defined as DAS28 and CRP<2.6.	Through Month 24

External Links

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