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.

NCT05153200 | Unknown Phase 4

• 1 other identifier: 20210654-01H
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• Recruitment Rate

  Number of participants recruited to study

  1 year

• Retention Rate

  Proportion of participants who complete the 6 months of follow-up

  6 months

Secondary Outcomes (25)

• Change in 100 mm Pain visual analogue scale (VAS)

  6 months

• Change in McGill Pain Questionnaire (MPQ)

  6 months

• Change in Widespread Pain Index (WPI)

  6 months

• Change in PainDETECT Questionnaire (PDQ)

  6 months

• Change in OMERACT (Outcome Measures in Rheumatoid Arthritis in Clinical Trials) ultrasound task force Global Synovitis Score (GLOESS).

  6 months

Study Arms (2)

Upadacitinib(Rinvoq)

EXPERIMENTAL

Upadacitinib(Rinvoq) 15 mg po daily

Drug: Upadacitinib

Adalimumab(Idacio)

ACTIVE COMPARATOR

Drug: Adalimumab

Interventions

Upadacitinib DRUG

15 mg po daily

Also known as: Rinvoq

Upadacitinib(Rinvoq)

Adalimumab DRUG

40 mg sc every other week

Also known as: Idacio

Adalimumab(Idacio)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• The Ottawa Hospital: collaborator
• University of Ottawa: collaborator

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

upadacitinib; Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Elliot P Hepworth, MD

CONTACT

613-738-8400; elhepworth@toh.ca

Sibel Z Aydin, MD

CONTACT

(613) 738-8400; saydin@toh.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: MSK-US assessors will be blinded to treatment allocation, pain scores, and disease activity measures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 10, 2021
• Study Start: January 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: December 10, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share