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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
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 29, 2021
    Last Updated
    November 29, 2021
    Sponsor
    Ottawa Hospital Research Institute
    Collaborators
    The Ottawa Hospital, University of Ottawa
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    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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