NCT06215638

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

January 22, 2024

Status Verified

November 1, 2023

Enrollment Period

1.3 years

First QC Date

January 10, 2024

Last Update Submit

January 10, 2024

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritisBortezomibdifficult-to-treat rheumatoid arthritisrefractory rheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

  • ACR20

    The ACR response criteria for 20 percent improvement in disease activity

    From enrollment to week 12

Study Arms (1)

Bortezomib

EXPERIMENTAL
Drug: Bortezomib

Interventions

BortezomibDRUG

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

Bortezomib

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical Cllege Hospital

Beijing, Beijing Municipality, 100005, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2024

First Posted

January 22, 2024

Study Start

March 1, 2023

Primary Completion

June 30, 2024

Study Completion

December 30, 2024

Last Updated

January 22, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)