Spondyloarthritis
Conditions
Interventions
Experimental group:Upadacitinib dose reduction protocol:
After 12 weeks of treatment with Upadacitinib 15 mg once daily, if the patient achieves Low Disease Activity (LDA), the dose will be reduced to
Control group:Upadacitinib 15 mg administered orally once daily.
Sponsors
First Affiliated Hospital of Xinjiang Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18–59 years, male or female. 2. Disease Activity: • BASDAI score >= 4 (on a 0–10 scale). • Patient’s Global Assessment of disease activity (VAS) >= 4. • At least one objective sign of active inflammation on sacroiliac joint MRI at screening. 3. Tolerability: Able to tolerate Upadacitinib 15 mg orally once daily. 4. Laboratory Parameters (at screening): • Hepatic Function (must meet all): ? ALT = 60 mL/min. • Hemoglobin >= 90 g/L. • Absolute neutrophil count >= 1.5 × 10?/L. • Platelet count >= 100 × 10?/L. 5. Demographics: Age 18–60 years. Women of childbearing potential must agree to use effective contraception. 6. Concomitant Medications: Permitted to continue stable background therapy for at least 1 month prior to enrollment, including conventional synthetic DMARDs and NSAIDs.
Exclusion criteria
Exclusion criteria: 1. Comorbid Rheumatic or Spinal Diseases: Presence of other autoimmune diseases (e.g., rheumatoid arthritis, psoriatic arthritis, SpA associated with inflammatory bowel disease) or structural spinal lesions (e.g., vertebral fracture, severe deformity) that may confound efficacy assessment. 2. Infection Risk: Active infection (e.g., tuberculosis, HBV/HCV, HIV) or a history of recurrent infections. Recent live vaccination (e.g., herpes zoster vaccine) requires avoidance within 4 weeks after drug discontinuation. 3. Cardiovascular and Thrombotic Risk: Significant cardiovascular disease (NYHA Class III-IV heart failure, recent myocardial infarction/stroke) or high risk of thrombosis (history of deep vein thrombosis/pulmonary embolism, or requiring anticoagulation therapy). 4. History of Malignancy. 5. JAK Inhibitor Contraindications: Prior intolerance to JAK inhibitors (e.g., tofacitinib, baricitinib). Laboratory abnormalities: absolute neutrophil count < 1.5 × 10?/L, absolute lymphocyte count < 0.5 × 10?/L, hemoglobin < 8 g/dL. 6. Participation in other clinical trials within 4 weeks prior to enrollment. 7. Live vaccination within 4 weeks prior to enrollment. 8. Pregnancy or lactation. 9. Significant psychiatric disorder or history of substance abuse. 10. Any other condition that, in the investigator's judgment, would make the subject unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spondyloarthritis Research Consortium of Canada (SPARCC) Score;Ankylosing Spondylitis Disease Activity Score (ASDAS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Erythrocyte Sedimentation Rate;C-reactive protein;Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score;ASAS Health Index (ASAS-HI);Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL);Bath Ankylosing Spondylitis Functional Index (BASFI) score; | — |
Countries
China
Contacts
Public ContactLuo Li
The First Affiliated Hospital of Xinjiang Medical University
Outcome results
None listed