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Rheumatoid ArthritisPhase 4NCT05153200

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.

A Phase 4 study testing Upadacitinib and Adalimumab in people with Rheumatoid Arthritis, run by Ottawa Hospital Research Institute.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Upadacitinib and Adalimumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
Jan 2022to Jun 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Elliot P Hepworth, MD contact

613-738-8400 ext. 81571

elhepworth@toh.ca

Sibel Z Aydin, MD contact

(613) 738-8400 ext. 81840

saydin@toh.ca

About this study

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.

Read the 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.

Being tested
Upadacitinib, Adalimumab
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UpadacitinibDrug

    Also called Rinvoq

    15 mg po daily

  • AdalimumabDrug

    Also called Idacio

    40 mg sc every other week

Study groups in NCT05153200
Study groupRoleWhat they receive
Upadacitinib(Rinvoq)ExperimentalUpadacitinib(Rinvoq) 15 mg po daily
Receives: Drug: Upadacitinib
Adalimumab(Idacio)Active comparatorNot described
Receives: Drug: Adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment Rate

    Number of participants recruited to study

    Measured: 1 year

  2. Retention Rate

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

    Measured: 6 months

Secondary outcomes (25)

  1. Change in 100 mm Pain visual analogue scale (VAS)

    "no pain" and "pain as bad as it can be" as anchors (MCID=11 mm)

    Measured: 6 months

  2. Change in McGill Pain Questionnaire (MPQ)

    Detailed assessment of pain quantity, quality, and impact (MCID=5)

    Measured: 6 months

  3. Change in Widespread Pain Index (WPI)

    Score of 4 or more indicates widespread pain (no known MCID)

    Measured: 6 months

  4. Change in PainDETECT Questionnaire (PDQ)

    Nociceptive (PDQ<13, unclear pain PDQ 14-18, neuropathic pain >18)

    Measured: 6 months

  5. 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.

    Measured: 6 months

  6. Change in Swollen Joint Count (44)

    Measured: 6 months

  7. Change in Tender Joint Count (44)

    Measured: 6 months

  8. Change in Physician Global Assessment of Disease Severity

    VAS

    Measured: 6 months

  9. Change in Patient Global Assessment of Disease Severity

    VAS

    Measured: 6 months

  10. Change in Health Assessment Questionnaire

    Measured: 6 months

  11. American College of Rheumatology (ACR) 20 response

    Measured: 6 months

  12. ACR 50 response

    Measured: 6 months

  13. ACR 70 response

    Measured: 6 months

  14. Change in Erythrocyte Sedimentation Rate

    Measured: 6 months

  15. Change in C-Reactive Protein

    Measured: 6 months

  16. Change in Disease Activity Score (DAS)-28-ESR

    Measured: 6 months

  17. Change in DAS-28-CRP

    Measured: 6 Months

  18. Change in Clinical Disease Activity Index (CDAI)

    Measured: 6 months

  19. Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT)

    Measured: 6 months

  20. Change in Insomnia Severity Index (ISI)

    Measured: 6 months

  21. Change in Short Form 36 (SF-36)

    Measured: 6 months

  22. Change in Patient Health Questionnaire (PHQ-9)

    Measured: 6 months

  23. Adverse Events

    Measured: 6 months

  24. Serious Adverse Events

    Measured: 6 months

  25. Drop-out due to Adverse Events

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2021
  2. Study startJan 2022 (estimated)
  3. Primary completionJun 2023 (estimated)
  4. Study completionJun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05153200
Sponsor's protocol ID
20210654-01H
Status last verified
Nov 2021
First submitted
29 Nov 2021
Last updated
10 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Upadacitinib and Adalimumab in people with Rheumatoid Arthritis, run by Ottawa Hospital Research Institute.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Elliot P Hepworth, MD (613-738-8400 ext. 81571, elhepworth@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Rate (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05153200.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021.

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