Clinical trial NCT06215638: An Exploratory Clinical Study on Bortezomib for the Treatment of Refractory Rheumatoid Arthritis
Official title: An Exploratory Clinical Study on Bortezomib for the Treatment of Refractory Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
Bortezomib
difficult-to-treat rheumatoid arthritis
refractory rheumatoid arthritis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Age \&gt;18 years and \&lt;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 \&gt;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\&#39;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.

Primary outcomes:
measure: ACR20
timeFrame: From enrollment to week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical Cllege Hospital
state: Beijing
Study officials:
References: