Clinical trial NCT05153200: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: The Ottawa Hospital
name: University of Ottawa
First posted: 2021-12-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a 26-week phase 4 randomized, single-blind, parallel-group, active treatment-controlled pilot/feasibility study designed to primary assess recruitment and retention rates and to secondarily assess the efficacy of Upadacitinib vs Adalimumab in controlling multiple measures of pain and MSK-US-detected synovitis in those with Active Rheumatoid Arthritis.

Participants with active RA despite combination conventional synthetic Disease Modifying Antirheumatic Drugs (csDMARD), alternative biologic DMARD (bDMARD), or alternative targeted synthetic DMARD (tsDMARD) will be randomized in a 1:1 ratio to:

* Upadacitinib(Rinvoq) 15 mg orally (po) daily or
* Comparison Group: Adalimumab(Idacio) 40 mg subcutaneously (sc) every other week Baseline methotrexate may be continued if patient is receiving at time of study enrollment.

At 1 year after study initiation, recruitment rate over the first year will be measured and rate of 6-month participant retention will also be measured.

At baseline, 1 month, 3 months, and 6 months after initiation of study drug, disease activity, pain, MSK-US synovitis, and other patient important outcomes will be collected.

The study will be completed after 6-months of follow-up.

Eligibility 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

Primary outcomes:
measure: Recruitment Rate
timeFrame: 1 year
measure: Retention Rate
timeFrame: 6 months
Secondary outcomes:
measure: Change in 100 mm Pain visual analogue scale (VAS)
timeFrame: 6 months
measure: Change in McGill Pain Questionnaire (MPQ)
timeFrame: 6 months
measure: Change in Widespread Pain Index (WPI)
timeFrame: 6 months
measure: Change in PainDETECT Questionnaire (PDQ)
timeFrame: 6 months
measure: Change in OMERACT (Outcome Measures in Rheumatoid Arthritis in Clinical Trials) ultrasound task force Global Synovitis Score (GLOESS).
timeFrame: 6 months
measure: Change in Swollen Joint Count (44)
timeFrame: 6 months
measure: Change in Tender Joint Count (44)
timeFrame: 6 months
measure: Change in Physician Global Assessment of Disease Severity
timeFrame: 6 months
measure: Change in Patient Global Assessment of Disease Severity
timeFrame: 6 months
measure: Change in Health Assessment Questionnaire
timeFrame: 6 months
measure: American College of Rheumatology (ACR) 20 response
timeFrame: 6 months
measure: ACR 50 response
timeFrame: 6 months
measure: ACR 70 response
timeFrame: 6 months
measure: Change in Erythrocyte Sedimentation Rate
timeFrame: 6 months
measure: Change in C-Reactive Protein
timeFrame: 6 months
measure: Change in Disease Activity Score (DAS)-28-ESR
timeFrame: 6 months
measure: Change in DAS-28-CRP
timeFrame: 6 Months
measure: Change in Clinical Disease Activity Index (CDAI)
timeFrame: 6 months
measure: Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT)
timeFrame: 6 months
measure: Change in Insomnia Severity Index (ISI)
timeFrame: 6 months
measure: Change in Short Form 36 (SF-36)
timeFrame: 6 months
measure: Change in Patient Health Questionnaire (PHQ-9)
timeFrame: 6 months
measure: Adverse Events
timeFrame: 6 months
measure: Serious Adverse Events
timeFrame: 6 months
measure: Drop-out due to Adverse Events
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: