NCT05805891

Brief Summary

This is a single-center, single-arm, prospective study on the efficacy and safety of Bortezomib in addition to standard therapy in patients with refractory rheumatoid arthritis.

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
20

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Dec 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

First Submitted

Initial submission to the registry

March 22, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 10, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 30, 2023

Status Verified

March 1, 2023

Enrollment Period

1.5 years

First QC Date

March 22, 2023

Last Update Submit

August 29, 2023

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritisbortezomib

Outcome Measures

Primary Outcomes (1)

  • DAS28 remission or LDA at week 24

    Proportion of patients who achieve remission or low disease activity (LDA) at week 24 according to DAS 28.

    24 weeks

Secondary Outcomes (6)

  • DAS28 improvement at week 12

    12 weeks

  • SDAI improvement at week 12 and remission or LDA at week 24

    24 weeks

  • CDAI improvement at week 12 and remission or LDA at week 24

    24 weeks

  • ACR20, ACR50 and ACR70 at week 12 and week 24

    24 weeks

  • Changes in glucocorticoid dose

    24 weeks

  • +1 more secondary outcomes

Study Arms (1)

bortezomib

EXPERIMENTAL

bortezomib added on previous treatment

Drug: bortezomib

Interventions

bortezomibDRUG

bortezomib 2mg/week subcutaneous injection

bortezomib

Eligibility Criteria

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

You may qualify if:

  • Age between 18\~70 years.
  • Fulfilling the 2010 ACR/EULAR classification criteria for RA.
  • Failed to at least two bDMARDs (including but not limited to TNF inhibitors, IL-6 receptor inhibitors, T cell costimulation inhibitor and anti-B cell biologics) or tsDMARDs (including but not limited to JAK inhibitors) in combination with a csDMARD for at least 12 weeks. The dosage of cs/b/tsDMARDs needs to be stable for at least 6 weeks.
  • For patients receiving glucocorticoids, the dosage of GC needs to be less than or equal to 10mg prednisone equivalent and stable for at least 6 weeks.
  • For patients receiving non-steroid anti-inflammatory drugs, the dosage of NSAID needs to be stable for at least 2 weeks.
  • Neutrophil≥1.0×10\^9/L, platelet≥100×10\^9/L, alanine transaminase (ALT) and aspartate aminotransferase (AST) within 3 ULN, total bilirubin within 1.5 ULN.
  • Informed consent obtained.

You may not qualify if:

  • Other concomitant autoimmune diseases (except for Sjogren's syndrome secondary to rheumatoid arthritis).
  • The presence of severe uncontrolled cardiovascular, cerebrovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neuropsychiatric disorders, or abnormal laboratory tests. The investigators consider that participation in the study may make unacceptable risks to the subjects.
  • A history of malignancy with a clinical cure time of less than 5 years.
  • Pregnant or breast-feeding women, or planning to get pregnant or start breastfeeding during the study.
  • Vaccinated with live attenuated virus within 4 weeks before entering the study.
  • Allergic to bortezomib or mannitol.
  • Participated in any other investigational drug trial within 12 weeks before study initiation.
  • Active hepatitis or liver disease at the time of screening: Hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibodies (HCVAb) positive; (Note: If Hepatitis B Core Antibody, (HBcAb) is positive and HBsAg is negative, HBV-DNA detection will be performed, patient is eligible if HBV-DNA was negative).
  • Active herpes zoster infection, or severe infection requiring intravenous antibiotics or hospitalization occurred 12 weeks before study initiation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

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 Officials

  • Xinping Tian, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinping Tian, MD

CONTACT

86-13691165939tianxp6@126.com

Qian Wang, MD

CONTACT

86-13681211155zhengaqian@sina.com

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

March 22, 2023

First Posted

April 10, 2023

Study Start

December 1, 2023

Primary Completion

June 1, 2025

Study Completion

December 1, 2025

Last Updated

August 30, 2023

Record last verified: 2023-03

Locations

CN(1)