Rheumatoid Arthritis (RA)
Conditions
Keywords
Rheumatoid Arthritis, Upadacitinib, RINVOQ
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.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieve Clinical Remission | At Month 6 | Clinical remission is defined as Disease Activity Score at 28 joints (DAS28) C-reactive Protein (CRP)\<2.6. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Morning Stiffness | Baseline (Month 0) Through Month 24 | Duration of morning joint stiffness is defined using VAS, where a higher score indicates worse joint stiffness. |
| Severity of Morning Stiffness | Baseline (Month 0) Through Month 24 | Severity of morning joint stiffness is defined using VAS, where a higher score indicates worse joint stiffness. |
| Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) | 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). |
| Percentage of Participants Achieving Clinical Remission | 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. |
| Percentage of Participants Achieving Low Disease Activity (LDA) | Baseline (Month 0) Through Month 24 | LDA is defined as DAS28-CRP\<3.2, SDAI ≤11, CDAI ≤10. |
| Earliest Date When a Response to Treatment is Known to Have Occurred | Baseline (Month 0) Through Month 24 | Earliest date when a response to treatment is known to have occurred. |
| Earliest Date When Their RA is Known to have Returned (In those Participants who Achieve a Response to Treatment) | Through Month 24 | Earliest date when their RA is known to have returned (In those participants who achieve a response to treatment). |
| Change in DAS28-CRP Score | 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. |
| Change in CDAI Score | 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. |
| Change in Pain Using Visual Analogue Scale (VAS) | Baseline (Month 0) Through Month 24 | Pain is defined using VAS, where a higher score indicates worse pain. |
| Change in Swollen Joint Count | Baseline (Month 0) Through Month 24 | Change in Swollen Joint Count. |
| Change in Physical Function (HAQ-DI) Score | Baseline (Month 0) Through Month 24 | The HAQ DI is a questionnaire that determines physical function. |
| Change in Patient Assessment of Global Disease Activity (PtGA) | Baseline (Month 0) Through Month 24 | The PtGA is a outcome instrument to assess the participant's assessment of disease severity. |
| Change in Physician Assessment of Global Disease Activity (PGA) | Baseline (Month 0) Through Month 24 | The PGA is a outcome instrument to assess the participant's assessment of disease severity. |
| Percentage of Participants Who Discontinue Upadacitinib | Through Month 24 | Percentage of participants who discontinue Upadacitinib. |
| Time of Discontinuation from Upadacitinib Initiation Date | Through Month 24 | Time of discontinuation from Upadacitinib initiation date. |
| Reasons for Upadacitinib Treatment Discontinuation | Through Month 24 | Reasons for Upadacitinib treatment discontinuation. |
| Immediate Change in RA Medications Following Discontinuation of Upadacitinib | Through Month 24 | Immediate change in RA medications following discontinuation of Upadacitinib. |
| Percentage of Participants Who Achieve Sustained Remission Following Discontinuation of Upadacitinib | Through Month 24 | Clinical remission is defined as DAS28 and CRP\<2.6. |
| Change in Tender Joint Count | Baseline (Month 0) Through Month 24 | Change in Tender Joint Count. |
Countries
Canada
Outcome results
None listed