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Rheumatoid ArthritisPhase 3TRANSFORMNCT05090410

Efficacy and Safety of Selective JAK 1 Inhibitor Filgotinib in Active Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate

A Phase 3 study testing filgotinib 200mg/day and subcutaneous tocilizumab 162mg/biweekly 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 The sponsor has not verified this record for over two years, so it may be out of date.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?
filgotinib 200mg/day and subcutaneous tocilizumab 162mg/biweekly
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteJapan
Study dates
3 Mar 2021to 31 Dec 2023
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 ACR/EULAR 2010 RA Classification Criteria
  • with at least moderate disease activity defined as a DAS28-ESR ≥3.2 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 8 to 16 mg per week (stable doses of <8 mg per week are allowed only in the presence of intolerance to higher doses)
  • 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 >5 mg/day of prednisolone
  • applicable an item for the contraindication of filgotinib or tocilizumab
  • a previous use of a JAK inhibitor or IL-6 inhibitor
  • treatment with a corticosteroid and csDMARD and change of dose within 4 weeks prior to the providing consent
  • treatment with a biologic DMARD or a biosimilar DMARD (ie, infliximab, biosimilar of infliximab, adalimumab, biosimilar of adalimumab, golimumab, certolizumab pegol or abatacept) within 8 weeks prior to the providing consent
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  • treatment with a TNF inhibitor (ie, etanercept or biosimilar of etanercept) within 4 weeks prior to the providing consent
  • use of a prohibited drug or therapy, other than the agents noted above, within 4 weeks prior to the providing consent
  • 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)
  • current pregnancy, breastfeeding, or noncompliant with a medically approved contraceptive regimen during and 12 months after the study period
  • 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: Efficacy and Safety of Selective JAK 1 Inhibitor Filgotinib in Active Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate: Comparative Study With Filgotinib and Tocilizumab Examined by Clinical Index as Well as Musculoskeletal Ultrasound Assessment

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). The dysregulation of JAK-signal transducer and activator of transcription (STAT) pathways via overproduction of cytokines, such as interleukin-6 (IL-6) is involved in the pathogenesis of RA. Filgotinib is a selective JAK1 inhibitor to be approved for use in RA. Filgotinib is effective in suppressing disease activity and preventing the progression of joint destruction due to inhibition of the JAK-STAT pathway. IL-6 inhibitors such as tocilizumab also inhibit the JAK-STAT pathways due to inhibition of IL-6 signaling. We will evaluate whether the effectiveness and safety of filgotinib monotherapy is non-inferior to those of tocilizumab monotherapy in RA patients with inadequate response to MTX.

Being tested
filgotinib 200mg/day, subcutaneous tocilizumab 162mg/biweekly
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • filgotinib 200mg/dayDrug

    Patients will be randomized in a 1:1 ratio to the administration of filgotinib 200mg/day or subcutaneous tocilizumab 162mg/biweekly switched from MTX ± other csDMARDs throughout the study period.

  • subcutaneous tocilizumab 162mg/biweeklyDrug

    Patients will be randomized in a 1:1 ratio to the administration of filgotinib 200mg/day or subcutaneous tocilizumab 162mg/biweekly switched from MTX ± other csDMARDs throughout the study period.

Study groups in NCT05090410
Study groupRoleWhat they receive
Filgotinib monotherapyExperimentalThe administration of filgotinib 200mg/day switched from MTX ± other csDMARDs throughout the study period.
Receives: Drug: filgotinib 200mg/day
Tocilizumab monotherapyActive comparatorThe administration of subcutaneous tocilizumab 162mg/biweekly switched from MTX ± other csDMARDs throughout the study period.
Receives: Drug: subcutaneous tocilizumab 162mg/biweekly

What is being measured

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

  1. the proportion of patients who achieve an American College of Rheumatology (ACR) 50 response

    Measured: at week 12

Secondary outcomes (17)

  1. the proportion of patients who achieve an ACR20 response

    Measured: at weeks 2, 4, 8, 12, 24, 36 and 52

  2. the proportion of patients who achieve an ACR50 response

    Measured: at weeks 2, 4, 8, 24, 36 and 52

  3. the proportion of patients who achieve an ACR70 response

    Measured: at weeks 2, 4, 8, 12, 24, 36 and 52

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

    Higher scores mean a more active of RA.

    Measured: from baseline to weeks 2, 4, 8, 12, 24, 36, and 52

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

    Higher scores mean a more active RA.

    Measured: from baseline to weeks 2, 4, 8, 12, 24, 36, and 52

  6. changes in the Disease Activity Score (DAS)28-ESR value

    Higher scores mean a more active RA.

    Measured: from baseline to weeks 2, 4, 8, 12, 24, 36, and 52

  7. changes in the DAS28-CRP value

    Higher scores mean a more active RA.

    Measured: from baseline to weeks 2, 4, 8, 12, 24, 36, and 52

  8. 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 2, 4, 12, 24, 36, and 52

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

    Higher scores mean a more active RA.

    Measured: from baseline to weeks 4, 12, 24, 36, and 52

  10. changes in the total grayscale (GS) score

    Higher scores mean a more active RA.

    Measured: from baseline to weeks 4, 12, 24, 36, and 52

  11. changes in the combined PD score

    Higher scores mean a more active RA.

    Measured: from baseline to weeks 4, 12, 24, 36, and 52

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

    Higher scores mean a more joint destruction and deformity.

    Measured: from baseline to weeks 24 and 52

  13. change in the Health Assessment Questionnaire-Disability Index (HAQ-DI) data

    Higher scores mean a more active RA.

    Measured: from baseline to weeks 2, 4, 8, 12, 24, 36, and 52

  14. change in the EuroQol 5 Dimensions 5-Level (EQ-5D-5L) data

    Higher scores mean a worse QOL.

    Measured: from baseline to weeks 2, 4, 8, 12, 24, 36, and 52

  15. change in the Functional Assessment of Chronic Illness-Fatigue (FACIT-F) data

    Higher scores mean a worse fatigue.

    Measured: from baseline to weeks 2, 4, 8, 12, 24, 36, and 52

  16. changes in the morning stiffness duration

    Higher scores mean a more active RA.

    Measured: from baseline to weeks 2, 4, 8, 12, 24, 36, and 52

  17. changes in the morning stiffness activity

    We analyze the visual analog scale of morning stiffness activity. Higher scores mean a more active RA.

    Measured: from baseline to weeks 2, 4, 8, 12, 24, 36, and 52

Timeline

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

  1. First posted22 Oct 2021
  2. Study start3 Mar 2021
  3. Primary completion28 Feb 2023 (estimated)
  4. Study completion31 Dec 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05090410
Sponsor's protocol ID
CRB20_026
Acronym
TRANSFORM
Status last verified
Oct 2021
First submitted
30 Sep 2021
Last updated
1 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shimizu T, Kawashiri SY, Koga T, Kiya R, Morita M, Kawasaki R, Kuroda S, Tashiro S, Sato S, Yabe M, Misaki K, Hanai S, Nakagomi D, Ogasawara M, Tamura N, Watanabe R, Kanazawa H, Atsumi T, Ueki Y, Okano T, Suzuki T, Takaoka H, Hamada H, Hidaka T, Furuta S, Hosogaya N, Yamamoto H, Kawakami A. Efficacy and safety of filgotinib versus tocilizumab in active rheumatoid arthritis: A randomized, open-label, multicenter study with clinical and musculoskeletal ultrasound evaluation (TRANSFORM study). Drug Discov Ther. 2026 May 17;20(2):175-189. doi: 10.5582/ddt.2026.01008. Epub 2026 Apr 27.

    PubMed 42036316

  • Shimizu T, Kawashiri SY, Morimoto S, Kawazoe Y, Kuroda S, Kawasaki R, Ito Y, Kiya R, Sato S, Yamamoto H, Kawakami A. Efficacy and safety of selective JAK 1 inhibitor filgotinib in active rheumatoid arthritis patients with inadequate response to methotrexate: comparative study with filgotinib and tocilizumab examined by clinical index as well as musculoskeletal ultrasound assessment (TRANSFORM study): study protocol for a randomized, open-label, parallel-group, multicenter, and non-inferiority clinical trial. Trials. 2023 Mar 3;24(1):161. doi: 10.1186/s13063-023-07176-5.

    PubMed 36869356

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing filgotinib 200mg/day and subcutaneous tocilizumab 162mg/biweekly 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 6 inclusion and 11 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 1 Nov 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?

the proportion of patients who achieve an American College of Rheumatology (ACR) 50 response (time frame: at week 12). 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 NCT05090410, which also lists 2 linked publications.

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 1 Nov 2021.

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