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

Not Applicable

Active, not recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Bortezomib

• Registration Number: NCT06215638
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-01
• Status Verified: 2023-11
• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-01-10
• Last Update Submitted: 2024-01-10
• Study First Posted: 2024-01-22
• Last Update Posted: 2024-01-22
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bortezomib	Bortezomib	-

Primary Outcome Measures

Name	Time	Method
ACR20	From enrollment to week 12	The ACR response criteria for 20 percent improvement in disease activity

Trial Locations

Locations (1)

Peking Union Medical Cllege Hospital; 🇨🇳 Beijing, Beijing, China