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

NCT ID: NCT06215638

Last Updated: 2024-01-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-12-30

Brief Summary

The goal of this prospective single-arm open-label trial is to learn about efficacy and safety of Bortezomib in treating patients with difficult-to-treat rheumatoid arthritis. The main questions it aims to answer are:

• Is Bortezomib an effective treatment option for patients with difficult-to-treat rheumatoid arthritis?
• Is Bortezomib safe enough in treating patients with difficult-to-treat rheumatoid arthritis?

Participants will:

• Receive Bortezomib 2 mg per week subcutaneously for twelve weeks in total.
• Follow-up at weeks 4, 12, and 24, while biosamples will be collected.

Conditions

Rheumatoid Arthritis

Study Design

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

Study Groups

Bortezomib

Group Type: EXPERIMENTAL

Bortezomib

Intervention Type: DRUG

Bortezomib 2 mg per week subcutaneously, for twelve weeks in total

Interventions

Bortezomib

Bortezomib 2 mg per week subcutaneously, for twelve weeks in total

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age >18 years and <70 years;
• Absolute neutrophil count ≥1.0×10^9/L, platelet count ≥100×10^9/L, aspartate transaminase and total bilirubin within 3 times and 1.5 times the normal upper limit, respectively, and serum creatinine clearance >60 ml/min;
• Voluntarily sign an informed consent form.

Exclusion Criteria

• Individuals with concomitant autoimmune diseases;
• Presence of severe, poorly controlled cardiovascular, cerebrovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neuropsychiatric diseases, or laboratory abnormalities that the investigator deems an unacceptable risk for the participant's involvement in the study;
• History of malignant tumors (or clinical cure time less than 5 years);
• Subjects who are pregnant or lactating, or planning to become pregnant or start breastfeeding during the study period;
• Vaccination with live virus vaccines within the 4 weeks prior to study entry;
• Allergy to Borussertib or mannitol;
• Participation in any other investigational drug trial in the 12 weeks before the start of this study medication;
• Presence of active hepatitis or a history of severe liver disease at screening: defined as a positive test for hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibodies (HCVAb) (Note: If the result of hepatitis B core antibody (HBcAb) is positive and HBsAg is negative, hepatitis B virus (HBV) DNA testing will be performed. If HBV-DNA is negative, the patient is eligible.);
• Active herpes zoster infection, or occurrence of a severe infection in the 12 weeks before the start of the study medication (defined as requiring intravenous antibiotics or hospitalization);
• Other situations that investigators deem unsuitable for inclusion.

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

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking Union Medical Cllege Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

I-23PJ350

Identifier Type: -

Identifier Source: org_study_id