Bortezomib for the Treatment of Refractory Rheumatoid Arthritis

NCT ID: NCT05805891

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2025-12-31

Brief Summary

This is a single-center, single-arm, prospective study on the efficacy and safety of Bortezomib in addition to standard therapy in patients with refractory rheumatoid arthritis.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

bortezomib

bortezomib added on previous treatment

Group Type: EXPERIMENTAL

bortezomib

Intervention Type: DRUG

bortezomib 2mg/week subcutaneous injection

Interventions

bortezomib

bortezomib 2mg/week subcutaneous injection

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese SLE Treatment And Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xinping Tian, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xinping Tian, MD

Role: CONTACT

tianxp6@126.com

86-13691165939

Qian Wang, MD

Role: CONTACT

zhengaqian@sina.com

86-13681211155

Facility Contacts

Xinping Tian, MD

Role: primary

tianxp6@126.com

86-13691165939

Qian Wang, MD

Role: backup

zhengaqian@sina.com

86-13681211155

Other Identifiers

Bortezomib-RA

Identifier Type: -

Identifier Source: org_study_id