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Rheumatoid ArthritisPhase 3DOPPLERNCT05121298

Discontinuation of Methotrexate in Rheumatoid Arthritis Patients Achieving Clinical Remission by Treatment With Upadacitinib Plus Methotrexate

A Phase 3 study testing upadacitinib 15mg/day in people with Rheumatoid Arthritis and JAK Inhibitor, run by Atsushi Kawakami at 1 site in Japan.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 administration of Janus kinase (JAK) inhibitors as well as biological disease-modifying anti-rheumatic drugs has dramatically improved even the clinical outcomes in rheumatoid arthritis (RA) patients with inadequate response to methotrexate (MTX). Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
upadacitinib 15mg/day
Could I receive a placebo?
No, everyone receives an active treatment
How many people
155 participants
Where
1 siteJapan
Study dates
12 Jan 2021to 30 Sep 2024
Phase
Phase 3
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must meet all of the following requirements to be considered for entry into the study:
  • ≥20 years old
  • with the diagnosis of RA based on the American College of Rheumatology (ACR) /EULAR 2010 RA Classification Criteria
  • with at least moderate DAS28-CRP >3.2 at the eligibility evaluation
  • with at least one PD score positive joint of 22 joints examined MSUS at the eligibility evaluation
  • treated with MTX for ≥8 weeks prior to the providing consent, including 4 weeks or more at the same doses of 6 to 16 mg per week
  • ability and willingness to provide written informed consent and comply with the requirements of the study protocol.

Who cannot join

  • The exclusion criteria are as follows:
  • concurrent use of a corticosteroid equivalent to >7.5 mg/day of prednisolone (2) applicable an item for the contraindication of upadacitinib (3) a previous use of a JAK inhibitor (4) treatment with a corticosteroid and change of dose within 4 weeks prior to the providing consent (5) treatment with a csDMARD except MTX within 2 weeks prior to the providing consent; (6) treatment with a biologic DMARD or a biosimilar DMARD (ie, infliximab, biosimilar of infliximab, adalimumab, golimumab, certolizumab pegol, tocilizumab, sarilumab or abatacept) within 8 weeks prior to the providing consent (7) treatment with a TNF inhibitor (ie, etanercept or biosimilar of etanercept) within 4 weeks prior to the providing consent (8) use of a prohibited drug or therapy, other than the agents noted above, within 4 weeks prior to the providing consent (9) a complication causing musculoskeletal disorders other than RA (ie, ankylosing spondyloarthritis, reactive arthritis, psoriatic arthritis, crystal-induced arthritis, systemic lupus erythematosus, systemic scleroderma, inflammatory myopathy, or mixed connective tissue disease) (10) current pregnancy, breastfeeding, or noncompliant with a medically approved contraceptive regimen during and 12 months after the study period (11) inappropriateness for inclusion in this study as determined by the investigator

Trial locations and contacts

1 site in 1 country.

Atsushi Kawakami, MD, PhD contact

+81-95-819-7260

atsushik@nagasaki-u.ac.jp

Toshimasa Shimizu, MD, PhD contact

+81-95-819-8527

t.shimizu@nagasaki-u.ac.jp

Japan1 site, 1 recruiting

  • Nagasaki University Hospital

    Nagasaki, 852-8501

    Atsushi Kawakami, MD, PhD, +81-95-819-7260, atsushik@nagasaki-u.ac.jp

    Toshimasa Shimizu, MD, PhD, +81-95-819-8527, t.shimizu@nagasaki-u.ac.jp

    Recruiting

Other trials in Japan

About this study

Official title: Discontinuation of Methotrexate in Rheumatoid Arthritis Patients Achieving Clinical Remission by Treatment With Upadacitinib Plus Methotrexate: an Interventional, Multicenter, Prospective, Open-label, Single-arm Clinical Trial With Clinical, Ultrasound and Biomarker Assessments

The administration of Janus kinase (JAK) inhibitors as well as biological disease-modifying anti-rheumatic drugs has dramatically improved even the clinical outcomes in rheumatoid arthritis (RA) patients with inadequate response to methotrexate (MTX). Upadacitinib is a selective JAK1 inhibitor to be approved for use in RA. Nearly half of patients added JAK inhibitors including upadacitinib can achieve clinical remission in RA patients with inadequate response to MTX. As the next step, it is the great issue whether disease activity can be maintained in good condition even if MTX is discontinued after achieving clinical remission in patients treated with the combination of JAK inhibitors and MTX. Thus, it is desirable to investigate the maintenance of clinical non-relapse after discontinuation of MTX in RA patients with clinical remission during treatment with upadacitinib plus MTX. In this study, we will evaluate the proportion of patients who maintained nonclinical relapse after discontinuation of MTX in patients with RA who achieved clinical remission after treatment with upadacitinib plus MTX. We will also use musculoskeletal ultrasound (MSUS) assessments to determine whether discontinuation of MTX can be maintained nonclinical relapse in RA patients achieving clinical remission.

Being tested
upadacitinib 15mg/day
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • upadacitinib 15mg/dayDrug

    Patients will receive upadacitinib 15mg/day and continue to receive same doses of MTX until 24 weeks. If patients achieve a European League Against Rheumatism (EULAR) moderate response or a Disease Activity Score 28 (DAS28-CRP) ≤3.2 at 12 weeks, and a DAS28-CRP of <2.6 at 24 weeks, they will discontinue MTX, and continue upadacitinib until 48 weeks.

Study groups in NCT05121298
Study groupRoleWhat they receive
UpadacitinibExperimentalThe administration of upadacitinib 15mg/day
Receives: Drug: upadacitinib 15mg/day

What is being measured

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

  1. maintenance of DAS28-CRP <=3.2 from week 24 to 48 in patients who achieve the DAS28-CRP <2.6 at week 24.

    Measured: at week 48

Secondary outcomes (24)

  1. achievement of DAS28-CRP <=3.2

    Measured: at weeks 12, 24 and 36

  2. achievement of DAS28-CRP <2.6

    Measured: at weeks 12, 24, 36 and 48

  3. clinical relapse (DAS28-CRP >3.2) at week 48 in patients who achieve the DAS28-CRP <2.6 at week 24

    Measured: at week 48

  4. achievement of EULAR moderate response

    Measured: at week 12

  5. changes in the DAS28-CRP value

    Higher scores mean a more active RA.

    Measured: from baseline to weeks 12, 24, 36, and 48

  6. changes in the DAS28-ESR value

    Higher scores mean a more active RA.

    Measured: from baseline to weeks 12, 24, 36, and 48

  7. changes in the DAS28-CRP value

    Higher scores mean a more active RA.

    Measured: from week 24 to weeks 36 and 48

  8. changes in the DAS28-ESR value

    Higher scores mean a more active RA.

    Measured: from week 24 to weeks 36 and 48

  9. changes in the clinical disease activity index (CDAI) value

    Higher scores mean a more active of RA.

    Measured: from baseline to weeks 12, 24, 36, and 48

  10. changes in the simplified disease activity index (SDAI) value

    Higher scores mean a more active of RA.

    Measured: from baseline to weeks 12, 24, 36, and 48

  11. changes in the clinical disease activity index (CDAI) value

    Higher scores mean a more active of RA.

    Measured: from week 24 to weeks 36 and 48

  12. changes in the simplified disease activity index (SDAI) value

    Higher scores mean a more active of RA.

    Measured: from week 24 to weeks 36 and 48

  13. achievement of CDAI <=2.8

    Measured: at weeks 12, 24, 36 and 48

  14. achievement of SDAI <=3.3

    Measured: at weeks 12, 24, 36 and 48

  15. changes in the serum levels of biomarkers

    We analyze the serum levels of multiple biomarkers such as cytokines and chemokines.

    Measured: from baseline to weeks 12, 24, 36, and 48

  16. changes in the serum levels of biomarkers

    We analyze the serum levels of multiple biomarkers such as cytokines and chemokines.

    Measured: from week 24 to weeks 36 and 48

  17. changes in the total power Doppler (PD) score

    The minimum: 0, max: 66. Higher scores mean a more active RA.

    Measured: from baseline to weeks 12, 24, 36, and 48

  18. changes in the total grayscale (GS) score

    The minimum: 0, max: 66. Higher scores mean a more active RA.

    Measured: from baseline to weeks 12, 24, 36, and 48

  19. changes in the combined PD score

    The minimum: 0, max: 66. Higher scores mean a more active RA.

    Measured: from baseline to weeks 12, 24, 36, and 48

  20. changes in the total PD score

    The minimum: 0, max: 66. Higher scores mean a more active RA.

    Measured: from week 24 to weeks 36 and 48

  21. changes in the total GS score

    The minimum: 0, max: 66. Higher scores mean a more active RA.

    Measured: from week 24 to weeks 36 and 48

  22. changes in the combined PD score

    The minimum: 0, max: 66. Higher scores mean a more active RA.

    Measured: from week 24 to weeks 36 and 48

  23. change in van der Heijde-modified total Sharp score (vdH-mTSS)

    The minimum: 0, max: 3. Higher scores mean a more joint destruction and deformity.

    Measured: from baseline to weeks 12, 24, 36 and 48

  24. change in vdH-mTSS

    Higher scores mean a more joint destruction and deformity.

    Measured: from week 24 to weeks 36 and 48

Timeline

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

  1. First posted16 Nov 2021
  2. Study start12 Jan 2021
  3. Primary completion30 Nov 2023 (estimated)
  4. Study completion30 Sep 2024 (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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
155 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05121298
Sponsor's protocol ID
CRB20-024
Acronym
DOPPLER
Status last verified
Nov 2021
First submitted
4 Nov 2021
Last updated
8 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Shimizu T, Kawashiri SY, Sato S, Kawazoe Y, Kuroda S, Kawasaki R, Ito Y, Morimoto S, Yamamoto H, Kawakami A. Discontinuation of methotrexate in rheumatoid arthritis patients achieving clinical remission by treatment with upadacitinib plus methotrexate (DOPPLER study): A study protocol for an interventional, multicenter, open-label and single-arm clinical trial with clinical, ultrasound and biomarker assessments. Medicine (Baltimore). 2022 Jan 14;101(2):e28463. doi: 10.1097/MD.0000000000028463.

    PubMed 35029189

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing upadacitinib 15mg/day in people with Rheumatoid Arthritis and JAK Inhibitor, run by Atsushi Kawakami at 1 site in Japan.

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 7 inclusion and 2 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 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Atsushi Kawakami, MD, PhD (+81-95-819-7260, atsushik@nagasaki-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

maintenance of DAS28-CRP <=3.2 from week 24 to 48 in patients who achieve the DAS28-CRP <2.6 at week 24. (time frame: at week 48). 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 NCT05121298, which also lists 1 linked publication.

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 8 Dec 2021.

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