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.

Rheumatoid Arthritis Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05153200
• Other study ID #: 20210654-01H
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 2022
• Est. completion date: June 2023

Study information

• Verified date: November 2021
• Source: Ottawa Hospital Research Institute
• Contact: Elliot P Hepworth, MD
• Phone: 613-738-8400
• Email: elhepworth[@]toh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis
• Synovitis

Intervention

Drug:
• Upadacitinib
15 mg po daily
• Adalimumab
40 mg sc every other week

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	The Ottawa Hospital, University of Ottawa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate	Number of participants recruited to study	1 year
Primary	Retention Rate	Proportion of participants who complete the 6 months of follow-up	6 months
Secondary	Change in 100 mm Pain visual analogue scale (VAS)	"no pain" and "pain as bad as it can be" as anchors (MCID=11 mm)	6 months
Secondary	Change in McGill Pain Questionnaire (MPQ)	Detailed assessment of pain quantity, quality, and impact (MCID=5)	6 months
Secondary	Change in Widespread Pain Index (WPI)	Score of 4 or more indicates widespread pain (no known MCID)	6 months
Secondary	Change in PainDETECT Questionnaire (PDQ)	Nociceptive (PDQ<13, unclear pain PDQ 14-18, neuropathic pain >18)	6 months
Secondary	Change in OMERACT (Outcome Measures in Rheumatoid Arthritis in Clinical Trials) ultrasound task force Global Synovitis Score (GLOESS).	US assessment of 32 joints assessing for Gray-scale synovitis and power-Doppler findings.	6 months
Secondary	Change in Swollen Joint Count (44)		6 months
Secondary	Change in Tender Joint Count (44)		6 months
Secondary	Change in Physician Global Assessment of Disease Severity	VAS	6 months
Secondary	Change in Patient Global Assessment of Disease Severity	VAS	6 months
Secondary	Change in Health Assessment Questionnaire		6 months
Secondary	American College of Rheumatology (ACR) 20 response		6 months
Secondary	ACR 50 response		6 months
Secondary	ACR 70 response		6 months
Secondary	Change in Erythrocyte Sedimentation Rate		6 months
Secondary	Change in C-Reactive Protein		6 months
Secondary	Change in Disease Activity Score (DAS)-28-ESR		6 months
Secondary	Change in DAS-28-CRP		6 Months
Secondary	Change in Clinical Disease Activity Index (CDAI)		6 months
Secondary	Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT)		6 months
Secondary	Change in Insomnia Severity Index (ISI)		6 months
Secondary	Change in Short Form 36 (SF-36)		6 months
Secondary	Change in Patient Health Questionnaire (PHQ-9)		6 months
Secondary	Adverse Events		6 months
Secondary	Serious Adverse Events		6 months
Secondary	Drop-out due to Adverse Events		6 months