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.
- Sponsor
- Ottawa Hospital Research Institute
- Study ID
- NCT05153200
- Phase
- PHASE4
- Status
- Unknown
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Upadacitinib — DRUG15 mg po daily
- Adalimumab — DRUG40 mg sc every other week
Study Details
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.
Key Dates
- Start date
- Jan 31, 2022
- Status verified
- Nov 2021
- Primary completion
- Jun 30, 2023
- Completion
- Jun 30, 2023
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Upadacitinib(Rinvoq)Upadacitinib(Rinvoq) 15 mg po daily
- Active Comparator: Adalimumab(Idacio)
Primary Outcome Measure
Recruitment Rate [ Time Frame: 1 year ]
Central Contacts
- Elliot P Hepworth, MD613-738-8400
- Sibel Z Aydin, MD(613) 738-8400
Related Studies
- CorEvitas Rheumatoid Arthritis (RA) Drug Safety & Effectiveness RegistryEnrolling By Invitation · CorEvitas · Waltham, Massachusetts
- Physica System Total Knee Replacement Registry StudyRecruiting · Limacorporate S.p.a · Rancho Mirage, California
- Early Rheumatoid Arthritis Lung Disease StudyRecruiting · University of Nebraska · Omaha, Nebraska
- Maternal Autoimmune Disease Research Alliance (MADRA) RegistryRecruiting · Duke University · Durham, North Carolina