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Completed

NCT Number: NCT04574492

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) 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.

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Key information

Conditions

Rheumatoid Arthritis (RA) Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rheumatology Research Associates /ID# 224534, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

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

    Time frame: Baseline (Month 0) Through Month 24

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

  2. Duration of Morning Stiffness

    Time frame: Baseline (Month 0) Through Month 24

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

  3. Severity of Morning Stiffness

    Time frame: Baseline (Month 0) Through Month 24

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

  4. Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)

    Time frame: Baseline (Month 0) Through Month 24

    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).

  5. Percentage of Participants Achieving Clinical Remission

    Time frame: Baseline (Month 0) Through Month 24

    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.

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

    Time frame: Baseline (Month 0) Through Month 24

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

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

    Time frame: Baseline (Month 0) Through Month 24

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

  8. Earliest Date When Their RA is Known to have Returned (In those Participants who Achieve a Response to Treatment)

    Time frame: Through Month 24

    Earliest date when their RA is known to have returned (In those participants who achieve a response to treatment).

  9. Change in DAS28-CRP Score

    Time frame: Baseline (Month 0) Through Month 24

    The DAS28-CRP used to evaluate disease activity in participants with RA, where worsening RA activity is defined by a higher score.

  10. Change in CDAI Score

    Time frame: Baseline (Month 0) Through Month 24

    The CDAI is used to evaluate disease activity in participants with RA , where worsening RA activity is defined by a higher score.

  11. Change in Tender Joint Count

    Time frame: Baseline (Month 0) Through Month 24

    Change in Tender Joint Count.

  12. Change in Swollen Joint Count

    Time frame: Baseline (Month 0) Through Month 24

    Change in Swollen Joint Count.

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

    Time frame: Baseline (Month 0) Through Month 24

    The HAQ DI is a questionnaire that determines physical function.

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

    Time frame: Baseline (Month 0) Through Month 24

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

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

    Time frame: Baseline (Month 0) Through Month 24

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

  16. Percentage of Participants Who Discontinue Upadacitinib

    Time frame: Through Month 24

    Percentage of participants who discontinue Upadacitinib.

  17. Time of Discontinuation from Upadacitinib Initiation Date

    Time frame: Through Month 24

    Time of discontinuation from Upadacitinib initiation date.

  18. Reasons for Upadacitinib Treatment Discontinuation

    Time frame: Through Month 24

    Reasons for Upadacitinib treatment discontinuation.

  19. Immediate Change in RA Medications Following Discontinuation of Upadacitinib

    Time frame: Through Month 24

    Immediate change in RA medications following discontinuation of Upadacitinib.

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

    Time frame: Through Month 24

    Clinical remission is defined as DAS28 and CRP<2.6.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Acronym: CLOSEUP

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 5, 2020
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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