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

N/ACompletedNCT04574492

AbbVie413 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

413

Conditions

Rheumatoid Arthritis (RA)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: At Month 6

Secondary Outcomes

Change in Pain Using Visual Analogue Scale (VAS)

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

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: Baseline (Month 0) Through Month 24

Change in Tender Joint Count

Change in Tender Joint Count.

Time frame: Baseline (Month 0) Through Month 24

Change in Swollen Joint Count

Change in Swollen Joint Count.

Time frame: Baseline (Month 0) Through Month 24

Change in Physical Function (HAQ-DI) Score

The HAQ DI is a questionnaire that determines physical function.

Time frame: 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.

Time frame: 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.

Time frame: Baseline (Month 0) Through Month 24

Percentage of Participants Who Discontinue Upadacitinib

Percentage of participants who discontinue Upadacitinib.

Time frame: Through Month 24

Time of Discontinuation from Upadacitinib Initiation Date

Time of discontinuation from Upadacitinib initiation date.

Time frame: Through Month 24

Reasons for Upadacitinib Treatment Discontinuation

Reasons for Upadacitinib treatment discontinuation.

Time frame: Through Month 24

Immediate Change in RA Medications Following Discontinuation of Upadacitinib

Immediate change in RA medications following discontinuation of Upadacitinib.

Time frame: Through Month 24

Percentage of Participants Who Achieve Sustained Remission Following Discontinuation of Upadacitinib

Clinical remission is defined as DAS28 and CRP\<2.6.

Time frame: Through Month 24

NCT04574492 - A Study of Oral Upadacitinib Tablets to Assess the Change in Disease Symptoms in Adult Canadian Participants With Moderate to Severe Rheumatoid Arthritis | Crick | Crick