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

Rheumatoid Arthritis Clinical Trial

— bortezomib4ra  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06215638
• Other study ID #: I-23PJ350
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: November 2023
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
China	Peking Union Medical Cllege Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACR20	The ACR response criteria for 20 percent improvement in disease activity	From enrollment to week 12