Discontinuation of methotrexate in rheumatoid arthritis patients achieving clinical remission by treatment with upadacitinib plus methotrexate (DOPPLER study): Study protocol for an interventional, multicenter, open-label and single-arm clinical trial with clinical, ultrasound and biomarker assessments

Recruiting

• Conditions: Rheumatoid arthritis

• Registration Number: jRCTs071200079

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-12
• Study Start: 2021-03-22
• Last Update Posted: 2025-06-24

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

1. Patients with 18 years older at the time of obtaining informed consent.
2. Patients with rheumatoid arthritis (RA) fulfilled the ACR/EULAR classification criteria for RA (2010).
3. Patients with moderate or more disease activity (DAS28-CRP > 3.2) at the time of the eligibility evaluation.
4. Patients have >= 1 power Doppler (PD) positive joint (of 22 examined using musculoskeletal ultrasound (MSUS)) at the time of the eligibility evaluation.
5. Patients who have received MTX treatment .
6. Patients who can personally provide written consent at their own free will after being receiving a thorough explanation of the study and fully understanding their participation in the study.

Exclusion Criteria

1. Patients treated with more than 7.5 mg per day of prednisolone.
2. Patients with contraindications to upadacitinib
3. Patients treated with two or more JAK inhibitors previously.
4. Patients treated with upadacitinib previously.
5. Patients with concurrent illness causing musculoskeletal disorders other than RA (ie, ankylosing spondylitis, reactive arthritis, psoriatic arthritis, crystal-induced arthritis, systemic lupus erythematosus, systemic scleroderma, inflammatory myopathy, and mixed connective tissue disease).
6. Women who are currently pregnant or will not be compliant with a medically approved contraceptive regimen during and 12 months after the study period and lactating women. Men who will not be compliant with a contraceptive regimen during and 12 months after the study period.
7. Patients who jugged unsuitable for this study by the investigator.Patients who jugged unsuitable for this study by the investigator .

Study & Design

• Study Type: Interventional
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
Proportion of subjects sustained therapeutic response (DAS28-CRP <= 3.2) after discontinuation of MTX	week 48	Proportion of subjects sustained therapeutic response (DAS28-CRP <= 3.2) after discontinuation of MTX in RA patients who achieve clinical remission (DAS28-CRP < 2.6) during treatment with upadacitinib plus MTX

Secondary Outcome Measures

Name	Time	Method
DAS28-CRP <= 3.2	week 12, 24 and 36	Proportion of subjects who achieve a DAS28-CRP <= 3.2
DAS28-CRP < 2.6	week 12, 24, 36 and 48	Proportion of subjects who achieve a DAS28-CRP < 2.6
Clinical non-relapse rate (DAS28-CRP <= 3.2)	week 48	Clinical non-relapse rate (DAS28-CRP <= 3.2) in subjects who progressed to Stage II
EULAR moderate response	week 12	Proportion of subjects who achieve an EULAR moderate response
DAS28-ESR/CRP	week 12, 24, 36 and 48	Changes in DAS28-ESR/CRP
CDAI/SDAI	week 12, 24, 36 and 48	Changes in CDAI/SDAI
CDAI <= 2.8/SDAI <= 3.3	week 12, 24, 36 and 48	Proportion of subjects who achieve a CDAI <= 2.8/SDAI <= 3.3
cytokines and other biomarkers	week 12, 24, 36, and 48	Changes in various cytokines and other biomarkers
total PD score, total GS score and composite score	week 12, 24, 36 and 48	Change in total PD score, total GS score and composite score
mTSS	week 24 and 48	Change in mTSS
HAQ-DI	week 12, 24, 36 and 48	Change in HAQ-DI