Rheumatoid Arthritis
Conditions
Interventions
Experimental group:Ivarmacitinib Monotherapy
Control Group:csDMARD Continuation
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 75 years inclusive, regardless of sex; 2.Diagnosed with rheumatoid arthritis (RA) according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA, with an ACR functional class of I to III at screening; 3.Having received continuous treatment with imaticitinib combined with csDMARDs prior to screening, and achieving low disease activity (LDA) at the screening assessment, defined as: DAS28-CRP <= 3.2; 4.Voluntarily sign the informed consent form prior to any study-related procedures, be able to understand the procedures and methods of this study, and be willing to strictly comply with the clinical study protocol to complete the study.
Exclusion criteria
Exclusion criteria: 1.Female subjects who are breastfeeding or pregnant, or subjects of childbearing potential who are unwilling to use effective contraception throughout the trial period and for 1 month after the last dose of imaticitinib tablets; 2.Subjects with an absolute lymphocyte count (ALC) = 3 × the upper limit of normal [ULN], or bilirubin >= 1.5 × ULN); patients with a history of latent or active tuberculosis who have not completed an adequate course of anti-tuberculosis treatment; 7.Patients with other concurrent rheumatic/immune diseases that may affect the assessment of RA activity, including but not limited to primary fibromyalgia, ankylosing spondylitis, systemic lupus erythematosus, scleroderma, or polymyositis; 8.Concomitant use of other JAK inhibitors, biologic disease-modifying antirheumatic drugs (bDMARDs), or other potent immunosuppressants (e.g., azathioprine, cyclosporine) during the treatment period with imaticitinib combined with csDMARDs prior to screening; 9.Prior to initiating treatment with imaticitinib combined with csDMARDs: use of anti-CD20 monoclonal antibodies (e.g., rituximab) within 6 months; use of other bDMARDs within 3 months, including but not limited to tumor necrosis factor-alpha antagonists (e.g., adalimumab, infliximab), interleukin-6 antagonists (e.g., tocilizumab), cytotoxic T-lymphocyte-associated antigen 4 inhibitors (e.g., abatacept). 10.Patients who have participated in other clinical trials within 30 days prior to the screening period; 11.Patients who refuse to sign the informed consent form; or who are unwilling or unable to cooperate with medical history collection and clinical photography; 12.Any other condition considered by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportions of patients achieving DAS28-CRP <= 3.2; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportions of patients achieving DAS28-CRP < 2.6, DAS28-CRP <= 3.2, ACR20, ACR50, and ACR70;Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) score;Incidence of adverse events (AEs) and serious adverse events (SAEs); | — |
Countries
China
Contacts
Public ContactPingting Yang
The First Hospital of China Medical University
Outcome results
None listed