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Rheumatoid Arthritis (RA)CLOSEUPNCT04574492

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

An observational study of Rheumatoid Arthritis (RA), run by AbbVie at 39 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis (RA)
How many people
413 participants
Where
39 sitesCanada
Study dates
7 Oct 2020to 30 Jul 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

39 sites in 1 country.

39 sites in 1 country

Canada39 sites

  • Dr. Viktoria Pavlova Medicine Professional Corporation /ID# 224536

    Ancaster, Ontario, L9G 3K9

  • Drs. Rai & Sekhon Medicine Professional Corporation /ID# 224366

    Brampton, Ontario, L6R 0W3

  • Dr. Sankalp V. Bhavsar Medicine Professional Corporation /ID# 223952

    Burlington, Ontario, L7R 2H3

  • Paolo Pace Medicine Professional Corporation /ID# 234057

    Cambridge, Ontario, N1R 4S1

  • Dr. Chrisostomos Kouroukis & Dr. Pauline Boulos MPC /ID# 223814

    Dundas, Ontario, L9H 1B7

  • Rheumatology Research Associates /ID# 224534

    Edmonton, Alberta, T5M 0H4

  • Saurash Reddy Professional Corporation /ID# 225288

    Edmonton, Alberta, T6G 0T2

  • Arthur Karasik Medicine Professional Corporation /ID# 225276

    Etobicoke, Ontario, M9C 5N2

  • Adachi Medicine Prof. Corp /ID# 223872

    Hamilton, Ontario, L8N 1Y2

  • St. Joseph's Healthcare /ID# 224042

    Hamilton, Ontario, L8N 4A6

  • West Mountain Medical Center /ID# 222975

    Hamilton, Ontario, L9C 5N2

  • Brandusa Florica Medicine Professional Corporation /ID# 222173

    Mississauga, Ontario, L5A 3V8

  • Credit Valley Rheumatology /ID# 219226

    Mississauga, Ontario, L5M 2V8

  • Imtiaz MS Khan Medicine Prof /ID# 225275

    Mississauga, Ontario, L5M 4N4

  • CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 225021

    Montreal, Quebec, H1T 2M4

  • Rheumatology Institute of Montreal /ID# 224045

    Montreal, Quebec, H2L 1S6

  • Applied Medical Informatics Research Inc. (AMIR) /ID# 224321

    Montreal, Quebec, H4A 3T2

  • Clinique de Rhumatologie de Montreal /ID# 221266

    Montreal, Quebec, H4N 1C6

  • Fraser Clinical Trials Inc /ID# 225200

    New Westminster, British Columbia, V3L 3W4

  • Rajwinder S. Dhillon Medicine /ID# 224365

    Niagara Falls, Ontario, L2E 6A6

  • Makhzoum Medicine Professional Corporation /Id# 229629

    Oakville, Ontario, L6H 3P1

  • Dr. S. Gill Medicine Professional Corporation /ID# 225238

    Oakville, Ontario, L6M 1M1

  • The Waterside Clinic /ID# 224205

    Orillia, Ontario, L3V 1T5

  • Dr. L. Lisnevskaia Medicine Professional Corporation /ID# 225645

    Oshawa, Ontario, L1H 1B9

  • Angela Montgomery Medicine Professional Corporation /ID# 231142

    Ottawa, Ontario, K1H 7X3

  • CISSSBSL -Hopital regional de Rimouski /ID# 224681

    Rimouski, Quebec, G5L 5T1

  • Groupe de Recherche en Maladies Osseuses Inc /ID# 222977

    Sainte-Foy, Quebec, G1V 3M7

  • Dr Naik-Medical Professional Corporation-Alliance Health /ID# 221195

    Saskatoon, Saskatchewan, S7H 5M7

  • Rheumatology Associates /ID# 228584

    Saskatoon, Saskatchewan, S7K 0H6

  • CIUSSS de l'Estrie - CHUS /ID# 225404

    Sherbrooke, Quebec, J1G 2E8

  • Niagara Peninsula Arthritis Ct /ID# 221472

    St. Catharines, Ontario, L2N 7E4

  • Eastern Regional Health Authority /ID# 223911

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Nexus Clinical Research /ID# 225896

    St. John's, Newfoundland and Labrador, A1B 5E8

  • Dr. Juris Lazovskis Inc. /ID# 224817

    Sydney, Nova Scotia, B1S 3N1

  • Centre de Recherche Musculo-Squelettique /ID# 224513

    Trois-Rivières, Quebec, G8Z 1Y2

  • Dr. Jonathan D. Chan Inc. /ID# 222976

    Vancouver, British Columbia, V5Z 1J9

  • Dr. Milton F. Baker Inc. /ID# 224555

    Victoria, British Columbia, V8P 5P6

  • Dr. Sabeen Anwar Medicine Professional Corporation /ID# 224797

    Windsor, Ontario, N8X 1T3

  • Manitoba Clinic /ID# 223288

    Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

About this study

Official title: 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.

Read more

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.

Keywords
Rheumatoid Arthritis, Upadacitinib, RINVOQ
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04574492
Study groupRoleWhat they receive
Participants receiving UpadacitinibParticipants receiving Upadacitinib for moderate to severe rheumatoid arthritis (RA).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At Month 6

Secondary outcomes (20)

  1. Change in Pain Using Visual Analogue Scale (VAS)

    Pain is defined using VAS, where a higher score indicates worse pain.

    Measured: Baseline (Month 0) Through Month 24

  2. Duration of Morning Stiffness

    Duration of morning joint stiffness is defined using VAS, where a higher score indicates worse joint stiffness.

    Measured: Baseline (Month 0) Through Month 24

  3. Severity of Morning Stiffness

    Severity of morning joint stiffness is defined using VAS, where a higher score indicates worse joint stiffness.

    Measured: Baseline (Month 0) Through Month 24

  4. 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).

    Measured: Baseline (Month 0) Through Month 24

  5. 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.

    Measured: Baseline (Month 0) Through Month 24

  6. Percentage of Participants Achieving Low Disease Activity (LDA)

    LDA is defined as DAS28-CRP<3.2, SDAI ≤11, CDAI ≤10.

    Measured: Baseline (Month 0) Through Month 24

  7. Earliest Date When a Response to Treatment is Known to Have Occurred

    Earliest date when a response to treatment is known to have occurred.

    Measured: Baseline (Month 0) Through Month 24

  8. 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).

    Measured: Through Month 24

  9. 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.

    Measured: Baseline (Month 0) Through Month 24

  10. 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.

    Measured: Baseline (Month 0) Through Month 24

  11. Change in Tender Joint Count

    Change in Tender Joint Count.

    Measured: Baseline (Month 0) Through Month 24

  12. Change in Swollen Joint Count

    Change in Swollen Joint Count.

    Measured: Baseline (Month 0) Through Month 24

  13. Change in Physical Function (HAQ-DI) Score

    The HAQ DI is a questionnaire that determines physical function.

    Measured: Baseline (Month 0) Through Month 24

  14. Change in Patient Assessment of Global Disease Activity (PtGA)

    The PtGA is a outcome instrument to assess the participant's assessment of disease severity.

    Measured: Baseline (Month 0) Through Month 24

  15. Change in Physician Assessment of Global Disease Activity (PGA)

    The PGA is a outcome instrument to assess the participant's assessment of disease severity.

    Measured: Baseline (Month 0) Through Month 24

  16. Percentage of Participants Who Discontinue Upadacitinib

    Percentage of participants who discontinue Upadacitinib.

    Measured: Through Month 24

  17. Time of Discontinuation from Upadacitinib Initiation Date

    Time of discontinuation from Upadacitinib initiation date.

    Measured: Through Month 24

  18. Reasons for Upadacitinib Treatment Discontinuation

    Reasons for Upadacitinib treatment discontinuation.

    Measured: Through Month 24

  19. Immediate Change in RA Medications Following Discontinuation of Upadacitinib

    Immediate change in RA medications following discontinuation of Upadacitinib.

    Measured: Through Month 24

  20. Percentage of Participants Who Achieve Sustained Remission Following Discontinuation of Upadacitinib

    Clinical remission is defined as DAS28 and CRP<2.6.

    Measured: Through Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2020
  2. Study start7 Oct 2020
  3. Primary completion30 Jul 2024
  4. Study completion30 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
413 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04574492
Sponsor's protocol ID
P20-096
Acronym
CLOSEUP
Status last verified
Aug 2025
First submitted
29 Sep 2020
Last updated
3 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Bessette L, Chan J, Chow A, Lisnevskaia L, Richard N, Fournier PA, Liazoghli D, Girard T, Haaland D. Real-World Effectiveness of Upadacitinib for Treatment of Rheumatoid Arthritis in Canadian Patients: Interim Results from the Prospective Observational CLOSE-UP Study. Rheumatol Ther. 2024 Jun;11(3):563-582. doi: 10.1007/s40744-024-00651-8. Epub 2024 Mar 11.

    PubMed 38467912

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis (RA), run by AbbVie at 39 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Achieve Clinical Remission (time frame: At Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04574492, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.

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