A Phase 3 interventional study of upadacitinib 15mg/day in Rheumatoid Arthritis, JAK Inhibitor and Musculoskeletal Ultrasound, sponsored by Atsushi Kawakami. Status unknown at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-12-08.
Sponsored by Atsushi Kawakami · Phase 3, Interventional, and Treatment
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's planned enrollment of 155 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Atsushi Kawakami is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Patients must meet all of the following requirements to be considered for entry into the study:
Exclusion Criteria:
The exclusion criteria are as follows:
(1) 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
The administration of upadacitinib 15mg/day
Drug: upadacitinib 15mg/day
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.
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
achievement of DAS28-CRP <=3.2
Time frame: at weeks 12, 24 and 36
achievement of DAS28-CRP <2.6
Time frame: at weeks 12, 24, 36 and 48
clinical relapse (DAS28-CRP >3.2) at week 48 in patients who achieve the DAS28-CRP <2.6 at week 24
Time frame: at week 48
achievement of EULAR moderate response
Time frame: at week 12
changes in the DAS28-CRP value
Higher scores mean a more active RA.
Time frame: from baseline to weeks 12, 24, 36, and 48
changes in the DAS28-ESR value
Higher scores mean a more active RA.
Time frame: from baseline to weeks 12, 24, 36, and 48
changes in the DAS28-CRP value
Higher scores mean a more active RA.
Time frame: from week 24 to weeks 36 and 48
changes in the DAS28-ESR value
Higher scores mean a more active RA.
Time frame: from week 24 to weeks 36 and 48
changes in the clinical disease activity index (CDAI) value
Higher scores mean a more active of RA.
Time frame: from baseline to weeks 12, 24, 36, and 48
changes in the simplified disease activity index (SDAI) value
Higher scores mean a more active of RA.
Time frame: from baseline to weeks 12, 24, 36, and 48
changes in the clinical disease activity index (CDAI) value
Higher scores mean a more active of RA.
Time frame: from week 24 to weeks 36 and 48
changes in the simplified disease activity index (SDAI) value
Higher scores mean a more active of RA.
Time frame: from week 24 to weeks 36 and 48
achievement of CDAI <=2.8
Time frame: at weeks 12, 24, 36 and 48
achievement of SDAI <=3.3
Time frame: at weeks 12, 24, 36 and 48
changes in the serum levels of biomarkers
We analyze the serum levels of multiple biomarkers such as cytokines and chemokines.
Time frame: from baseline to weeks 12, 24, 36, and 48
changes in the serum levels of biomarkers
We analyze the serum levels of multiple biomarkers such as cytokines and chemokines.
Time frame: from week 24 to weeks 36 and 48
changes in the total power Doppler (PD) score
The minimum: 0, max: 66. Higher scores mean a more active RA.
Time frame: from baseline to weeks 12, 24, 36, and 48
changes in the total grayscale (GS) score
The minimum: 0, max: 66. Higher scores mean a more active RA.
Time frame: from baseline to weeks 12, 24, 36, and 48
changes in the combined PD score
The minimum: 0, max: 66. Higher scores mean a more active RA.
Time frame: from baseline to weeks 12, 24, 36, and 48
changes in the total PD score
The minimum: 0, max: 66. Higher scores mean a more active RA.
Time frame: from week 24 to weeks 36 and 48
changes in the total GS score
The minimum: 0, max: 66. Higher scores mean a more active RA.
Time frame: from week 24 to weeks 36 and 48
changes in the combined PD score
The minimum: 0, max: 66. Higher scores mean a more active RA.
Time frame: from week 24 to weeks 36 and 48
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.
Time frame: from baseline to weeks 12, 24, 36 and 48
change in vdH-mTSS
Higher scores mean a more joint destruction and deformity.
Time frame: from week 24 to weeks 36 and 48
This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Atsushi Kawakami