An Exploratory Clinical Study on Bortezomib for the Treatment of Refractory Rheumatoid Arthritis (bortezomib4ra)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Bortezomib

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100005
      • Peking Union Medical Cllege Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bortezomib	Drug: Bortezomib; Bortezomib 2 mg per week subcutaneously, for twelve weeks in total

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACR20	The ACR response criteria for 20 percent improvement in disease activity	From enrollment to week 12

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: rheumatoid arthritis; Bortezomib; difficult-to-treat rheumatoid arthritis; refractory rheumatoid arthritis
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Antineoplastic Agents; Bortezomib
• Other Study ID Numbers: I-23PJ350

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No