Clinical trial NCT04574492: A Study of Oral Upadacitinib Tablets to Assess the Change in Disease Symptoms in Adult Canadian Participants With Moderate to Severe Rheumatoid Arthritis
Official title: Canadian Real-life Post-marketing Observational Study Assessing the Effectiveness of Upadacitinib for Treating Rheumatoid Arthritis (CLOSEUP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis (RA)
Keywords: Rheumatoid Arthritis
Upadacitinib
RINVOQ
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-10-05
Enrollment: 413
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants receiving Upadacitinib according to the product prescribing information, for moderate to severe active Rheumatoid Arthritis (RA).

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.


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.

Primary outcomes:
measure: Percentage of Participants Who Achieve Clinical Remission
timeFrame: At Month 6
Secondary outcomes:
measure: Change in Pain Using Visual Analogue Scale (VAS)
timeFrame: Baseline (Month 0) Through Month 24
measure: Duration of Morning Stiffness
timeFrame: Baseline (Month 0) Through Month 24
measure: Severity of Morning Stiffness
timeFrame: Baseline (Month 0) Through Month 24
measure: Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
timeFrame: Baseline (Month 0) Through Month 24
measure: Percentage of Participants Achieving Clinical Remission
timeFrame: Baseline (Month 0) Through Month 24
measure: Percentage of Participants Achieving Low Disease Activity (LDA)
timeFrame: Baseline (Month 0) Through Month 24
measure: Earliest Date When a Response to Treatment is Known to Have Occurred
timeFrame: Baseline (Month 0) Through Month 24
measure: Earliest Date When Their RA is Known to have Returned (In those Participants who Achieve a Response to Treatment)
timeFrame: Through Month 24
measure: Change in DAS28-CRP Score
timeFrame: Baseline (Month 0) Through Month 24
measure: Change in CDAI Score
timeFrame: Baseline (Month 0) Through Month 24
measure: Change in Tender Joint Count
timeFrame: Baseline (Month 0) Through Month 24
measure: Change in Swollen Joint Count
timeFrame: Baseline (Month 0) Through Month 24
measure: Change in Physical Function (HAQ-DI) Score
timeFrame: Baseline (Month 0) Through Month 24
measure: Change in Patient Assessment of Global Disease Activity (PtGA)
timeFrame: Baseline (Month 0) Through Month 24
measure: Change in Physician Assessment of Global Disease Activity (PGA)
timeFrame: Baseline (Month 0) Through Month 24
measure: Percentage of Participants Who Discontinue Upadacitinib
timeFrame: Through Month 24
measure: Time of Discontinuation from Upadacitinib Initiation Date
timeFrame: Through Month 24
measure: Reasons for Upadacitinib Treatment Discontinuation
timeFrame: Through Month 24
measure: Immediate Change in RA Medications Following Discontinuation of Upadacitinib
timeFrame: Through Month 24
measure: Percentage of Participants Who Achieve Sustained Remission Following Discontinuation of Upadacitinib
timeFrame: Through Month 24
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Rheumatology Research Associates /ID# 224534
state: Alberta
city: Edmonton
country: Canada
facility: Saurash Reddy Professional Corporation /ID# 225288
state: Alberta
city: New Westminster
country: Canada
facility: Fraser Clinical Trials Inc /ID# 225200
state: British Columbia
city: Vancouver
country: Canada
facility: Dr. Jonathan D. Chan Inc. /ID# 222976
state: British Columbia
city: Victoria
country: Canada
facility: Dr. Milton F. Baker Inc. /ID# 224555
state: British Columbia
city: Winnipeg
country: Canada
facility: Manitoba Clinic /ID# 223288
state: Manitoba
city: St. John's
country: Canada
facility: Eastern Regional Health Authority /ID# 223911
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Nexus Clinical Research /ID# 225896
state: Newfoundland and Labrador
city: Sydney
country: Canada
facility: Dr. Juris Lazovskis Inc. /ID# 224817
state: Nova Scotia
city: Ancaster
country: Canada
facility: Dr. Viktoria Pavlova Medicine Professional Corporation /ID# 224536
state: Ontario
city: Brampton
country: Canada
facility: Drs. Rai & Sekhon Medicine Professional Corporation /ID# 224366
state: Ontario
city: Burlington
country: Canada
facility: Dr. Sankalp V. Bhavsar Medicine Professional Corporation /ID# 223952
state: Ontario
city: Cambridge
country: Canada
facility: Paolo Pace Medicine Professional Corporation /ID# 234057
state: Ontario
city: Dundas
country: Canada
facility: Dr. Chrisostomos Kouroukis & Dr. Pauline Boulos MPC /ID# 223814
state: Ontario
city: Etobicoke
country: Canada
facility: Arthur Karasik Medicine Professional Corporation /ID# 225276
state: Ontario
city: Hamilton
country: Canada
facility: Adachi Medicine Prof. Corp /ID# 223872
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare /ID# 224042
state: Ontario
city: Hamilton
country: Canada
facility: West Mountain Medical Center /ID# 222975
state: Ontario
city: Mississauga
country: Canada
facility: Brandusa Florica Medicine Professional Corporation /ID# 222173
state: Ontario
city: Mississauga
country: Canada
facility: Credit Valley Rheumatology /ID# 219226
state: Ontario
city: Mississauga
country: Canada
facility: Imtiaz MS Khan Medicine Prof /ID# 225275
state: Ontario
city: Niagara Falls
country: Canada
facility: Rajwinder S. Dhillon Medicine /ID# 224365
state: Ontario
city: Oakville
country: Canada
facility: Makhzoum Medicine Professional Corporation /Id# 229629
state: Ontario
city: Oakville
country: Canada
facility: Dr. S. Gill Medicine Professional Corporation /ID# 225238
state: Ontario
city: Orillia
country: Canada
facility: The Waterside Clinic /ID# 224205
state: Ontario
city: Oshawa
country: Canada
facility: Dr. L. Lisnevskaia Medicine Professional Corporation /ID# 225645
state: Ontario
city: Ottawa
country: Canada
facility: Angela Montgomery Medicine Professional Corporation /ID# 231142
state: Ontario
city: St. Catharines
country: Canada
facility: Niagara Peninsula Arthritis Ct /ID# 221472
state: Ontario
city: Windsor
country: Canada
facility: Dr. Sabeen Anwar Medicine Professional Corporation /ID# 224797
state: Ontario
city: Montreal
country: Canada
facility: CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 225021
state: Quebec
city: Montreal
country: Canada
facility: Rheumatology Institute of Montreal /ID# 224045
state: Quebec
city: Montreal
country: Canada
facility: Clinique de Rhumatologie de Montreal /ID# 221266
state: Quebec
city: Montréal
country: Canada
facility: Applied Medical Informatics Research Inc. (AMIR) /ID# 224321
state: Quebec
city: Rimouski
country: Canada
facility: CISSSBSL -Hopital regional de Rimouski /ID# 224681
state: Quebec
city: Sainte-foy
country: Canada
facility: Groupe de Recherche en Maladies Osseuses Inc /ID# 222977
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie - CHUS /ID# 225404
state: Quebec
city: Trois-rivières
country: Canada
facility: Centre de Recherche Musculo-Squelettique /ID# 224513
state: Quebec
city: Saskatoon
country: Canada
facility: Dr Naik-Medical Professional Corporation-Alliance Health /ID# 221195
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Rheumatology Associates /ID# 228584
state: Saskatchewan
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: