Early Changes in Pain, Disease Activity, and Ultrasound Evidence of Inflammatory Synovitis in Patients Receiving JAK-inhibitor vs. TNF-inhibitor Therapy for Active Rheumatoid Arthritis: A Feasibility Study.

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this phase 4 pilot study is to assess 1-year recruitment, and 6-month retention rates for participants with rheumatoid arthritis (RA) recruited to this study. Secondarily, we aim to study the difference in multifaceted pain scoring and Musculoskeletal Ultrasound (MSK-US)-detected synovitis between those treated with Upadacitinib vs Adalimumab.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Collaborators: The Ottawa Hospital; University of Ottawa
• Treatments: Adalimumab; Upadacitinib

Criteria

Inclusion Criteria:

• Diagnosis of RA based on ACR/EULAR 2020 Classification Criteria

• Moderate-to-high disease activity according to clinical disease activity indices

• Referred to the biologics clinic (The Ottawa Hospital Arthritis Centre) by their primary rheumatologist who practices within the division following decision to escalate to, or switch between, advanced therapy.

Exclusion Criteria:

• Any contraindication to initiation of either Upadacitinib or Adalimumab

• Unable to come to follow-up at 1, 3, and 6 months

• Current or planned (within 6 months) pregnancy or breastfeeding

• Inability to give informed consent

• Inability to communicate verbal or written responses to pain questionnaires

• Intraarticular steroid injections if done within 30 days of first visit

• Initiation of study intervention prior to baseline assessment

• Previous use of either study drug