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.
Primary Purpose
Rheumatoid Arthritis
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Upadacitinib
Adalimumab
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Upadacitinib(Rinvoq)
Adalimumab(Idacio)
Arm Description
Upadacitinib(Rinvoq) 15 mg po daily
Outcomes
Primary Outcome Measures
Recruitment Rate
Number of participants recruited to study
Retention Rate
Proportion of participants who complete the 6 months of follow-up
Secondary Outcome Measures
Change in 100 mm Pain visual analogue scale (VAS)
"no pain" and "pain as bad as it can be" as anchors (MCID=11 mm)
Change in McGill Pain Questionnaire (MPQ)
Detailed assessment of pain quantity, quality, and impact (MCID=5)
Change in Widespread Pain Index (WPI)
Score of 4 or more indicates widespread pain (no known MCID)
Change in PainDETECT Questionnaire (PDQ)
Nociceptive (PDQ<13, unclear pain PDQ 14-18, neuropathic pain >18)
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.
Change in Swollen Joint Count (44)
Change in Tender Joint Count (44)
Change in Physician Global Assessment of Disease Severity
VAS
Change in Patient Global Assessment of Disease Severity
VAS
Change in Health Assessment Questionnaire
American College of Rheumatology (ACR) 20 response
ACR 50 response
ACR 70 response
Change in Erythrocyte Sedimentation Rate
Change in C-Reactive Protein
Change in Disease Activity Score (DAS)-28-ESR
Change in DAS-28-CRP
Change in Clinical Disease Activity Index (CDAI)
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT)
Change in Insomnia Severity Index (ISI)
Change in Short Form 36 (SF-36)
Change in Patient Health Questionnaire (PHQ-9)
Adverse Events
Serious Adverse Events
Drop-out due to Adverse Events
Full Information
NCT ID
NCT05153200
First Posted
November 29, 2021
Last Updated
November 29, 2021
Sponsor
Ottawa Hospital Research Institute
Collaborators
The Ottawa Hospital, University of Ottawa
1. Study Identification
Unique Protocol Identification Number
NCT05153200
Brief 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.
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
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
The Ottawa Hospital, University of Ottawa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
MSK-US assessors will be blinded to treatment allocation, pain scores, and disease activity measures.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Upadacitinib(Rinvoq)
Arm Type
Experimental
Arm Description
Upadacitinib(Rinvoq) 15 mg po daily
Arm Title
Adalimumab(Idacio)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
Rinvoq
Intervention Description
15 mg po daily
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Idacio
Intervention Description
40 mg sc every other week
Primary Outcome Measure Information:
Title
Recruitment Rate
Description
Number of participants recruited to study
Time Frame
1 year
Title
Retention Rate
Description
Proportion of participants who complete the 6 months of follow-up
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in 100 mm Pain visual analogue scale (VAS)
Description
"no pain" and "pain as bad as it can be" as anchors (MCID=11 mm)
Time Frame
6 months
Title
Change in McGill Pain Questionnaire (MPQ)
Description
Detailed assessment of pain quantity, quality, and impact (MCID=5)
Time Frame
6 months
Title
Change in Widespread Pain Index (WPI)
Description
Score of 4 or more indicates widespread pain (no known MCID)
Time Frame
6 months
Title
Change in PainDETECT Questionnaire (PDQ)
Description
Nociceptive (PDQ<13, unclear pain PDQ 14-18, neuropathic pain >18)
Time Frame
6 months
Title
Change in OMERACT (Outcome Measures in Rheumatoid Arthritis in Clinical Trials) ultrasound task force Global Synovitis Score (GLOESS).
Description
US assessment of 32 joints assessing for Gray-scale synovitis and power-Doppler findings.
Time Frame
6 months
Title
Change in Swollen Joint Count (44)
Time Frame
6 months
Title
Change in Tender Joint Count (44)
Time Frame
6 months
Title
Change in Physician Global Assessment of Disease Severity
Description
VAS
Time Frame
6 months
Title
Change in Patient Global Assessment of Disease Severity
Description
VAS
Time Frame
6 months
Title
Change in Health Assessment Questionnaire
Time Frame
6 months
Title
American College of Rheumatology (ACR) 20 response
Time Frame
6 months
Title
ACR 50 response
Time Frame
6 months
Title
ACR 70 response
Time Frame
6 months
Title
Change in Erythrocyte Sedimentation Rate
Time Frame
6 months
Title
Change in C-Reactive Protein
Time Frame
6 months
Title
Change in Disease Activity Score (DAS)-28-ESR
Time Frame
6 months
Title
Change in DAS-28-CRP
Time Frame
6 Months
Title
Change in Clinical Disease Activity Index (CDAI)
Time Frame
6 months
Title
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT)
Time Frame
6 months
Title
Change in Insomnia Severity Index (ISI)
Time Frame
6 months
Title
Change in Short Form 36 (SF-36)
Time Frame
6 months
Title
Change in Patient Health Questionnaire (PHQ-9)
Time Frame
6 months
Title
Adverse Events
Time Frame
6 months
Title
Serious Adverse Events
Time Frame
6 months
Title
Drop-out due to Adverse Events
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elliot P Hepworth, MD
Phone
613-738-8400
Ext
81571
Email
elhepworth@toh.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Sibel Z Aydin, MD
Phone
(613) 738-8400
Ext
81840
Email
saydin@toh.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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.
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