Using Bortezomib to treat difficult rheumatoid arthritis cases

An Exploratory Clinical Study on Bortezomib for the Treatment of Refractory Rheumatoid Arthritis

This study is testing if adding Bortezomib, a drug usually used for cancer, can help people with tough cases of rheumatoid arthritis who haven't found relief from other treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Chinese SLE Treatment And Research Group (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Beijing)
• Trial ID: NCT05805891 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of Bortezomib, a medication typically used for multiple myeloma, in patients with refractory rheumatoid arthritis who have not responded to standard treatments. It is a single-center, single-arm, prospective study, meaning all participants will receive the same treatment without a control group. The study aims to determine if adding Bortezomib to existing therapies can improve patient outcomes. Participants will be closely monitored for both efficacy and safety throughout the treatment period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with refractory rheumatoid arthritis who have failed multiple biologic or targeted therapies.

Not a fit: Patients with other autoimmune diseases or those who have not previously failed standard treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients with rheumatoid arthritis who have not responded to existing therapies.

How similar studies have performed: While the use of Bortezomib in rheumatoid arthritis is not widely tested, similar approaches in treating refractory conditions have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

1. Age between 18\~70 years.
2. Fulfilling the 2010 ACR/EULAR classification criteria for RA.
3. Failed to at least two bDMARDs (including but not limited to TNF inhibitors, IL-6 receptor inhibitors, T cell costimulation inhibitor and anti-B cell biologics) or tsDMARDs (including but not limited to JAK inhibitors) in combination with a csDMARD for at least 12 weeks. The dosage of cs/b/tsDMARDs needs to be stable for at least 6 weeks.
4. For patients receiving glucocorticoids, the dosage of GC needs to be less than or equal to 10mg prednisone equivalent and stable for at least 6 weeks.
5. For patients receiving non-steroid anti-inflammatory drugs, the dosage of NSAID needs to be stable for at least 2 weeks.
6. Neutrophil≥1.0×10\^9/L, platelet≥100×10\^9/L, alanine transaminase (ALT) and aspartate aminotransferase (AST) within 3 ULN, total bilirubin within 1.5 ULN.
7. Informed consent obtained.

Exclusion Criteria:

1. Other concomitant autoimmune diseases (except for Sjogren's syndrome secondary to rheumatoid arthritis).
2. The presence of severe uncontrolled cardiovascular, cerebrovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neuropsychiatric disorders, or abnormal laboratory tests. The investigators consider that participation in the study may make unacceptable risks to the subjects.
3. A history of malignancy with a clinical cure time of less than 5 years.
4. Pregnant or breast-feeding women, or planning to get pregnant or start breastfeeding during the study.
5. Vaccinated with live attenuated virus within 4 weeks before entering the study.
6. Allergic to bortezomib or mannitol.
7. Participated in any other investigational drug trial within 12 weeks before study initiation.
8. Active hepatitis or liver disease at the time of screening: Hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibodies (HCVAb) positive; (Note: If Hepatitis B Core Antibody, (HBcAb) is positive and HBsAg is negative, HBV-DNA detection will be performed, patient is eligible if HBV-DNA was negative).
9. Active herpes zoster infection, or severe infection requiring intravenous antibiotics or hospitalization occurred 12 weeks before study initiation.
10. Other conditions that not suitable for inclusion in the study, assessed by the investigators.

Where this trial is running

Beijing

• Peking Union Medical College Hospital — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Xinping Tian, MD — Peking Union Medical College Hospital
• Study coordinator: Xinping Tian, MD

Conditions Rheumatoid Arthritis; rheumatoid arthritis; bortezomib