search
Back to results

Bortezomib for the Treatment of Refractory Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
bortezomib
Sponsored by
Chinese SLE Treatment And Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis, bortezomib

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. Other conditions that not suitable for inclusion in the study, assessed by the investigators.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

bortezomib

Arm Description

bortezomib added on previous treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

DAS28 improvement at week 12
Proportion of patients who achieve remission or low disease activity at week 12 according to DAS 28. Proportion of patients who achieve at least a 50% reduction of DAS28 at week 12.
SDAI improvement at week 12 and remission or LDA at week 24
Proportions of patients who achieve remission or low disease activity at week 12 and week 24 according to SDAI. Proportion of patients who achieve at least a 50% reduction of SDAI at week 12.
CDAI improvement at week 12 and remission or LDA at week 24
Proportions of patients who achieve remission or low disease activity at week 12 and week 24 according to CDAI. Proportion of patients who achieve at least a 50% reduction of CDAI at week 12.
ACR20, ACR50 and ACR70 at week 12 and week 24
Proportions of patients who achieve ACR20, ACR50 and ACR70 at week 12 and week 24.
Changes in glucocorticoid dose
Changes in glucocorticoid dose at week 12 and 24 from baseline.
Adverse events during the study
All adverse events, severe adverse events and proportion of patients who discontinued bortezomib due to adverse events from the first dose of bortezomib to 4 weeks after the last dose.

Full Information

First Posted
March 22, 2023
Last Updated
August 29, 2023
Sponsor
Chinese SLE Treatment And Research Group
search

1. Study Identification

Unique Protocol Identification Number
NCT05805891
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chinese SLE Treatment And Research Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
rheumatoid arthritis, bortezomib

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
bortezomib
Arm Type
Experimental
Arm Description
bortezomib added on previous treatment
Intervention Type
Drug
Intervention Name(s)
bortezomib
Intervention Description
bortezomib 2mg/week subcutaneous injection
Primary Outcome Measure Information:
Title
DAS28 remission or LDA at week 24
Description
Proportion of patients who achieve remission or low disease activity (LDA) at week 24 according to DAS 28.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
DAS28 improvement at week 12
Description
Proportion of patients who achieve remission or low disease activity at week 12 according to DAS 28. Proportion of patients who achieve at least a 50% reduction of DAS28 at week 12.
Time Frame
12 weeks
Title
SDAI improvement at week 12 and remission or LDA at week 24
Description
Proportions of patients who achieve remission or low disease activity at week 12 and week 24 according to SDAI. Proportion of patients who achieve at least a 50% reduction of SDAI at week 12.
Time Frame
24 weeks
Title
CDAI improvement at week 12 and remission or LDA at week 24
Description
Proportions of patients who achieve remission or low disease activity at week 12 and week 24 according to CDAI. Proportion of patients who achieve at least a 50% reduction of CDAI at week 12.
Time Frame
24 weeks
Title
ACR20, ACR50 and ACR70 at week 12 and week 24
Description
Proportions of patients who achieve ACR20, ACR50 and ACR70 at week 12 and week 24.
Time Frame
24 weeks
Title
Changes in glucocorticoid dose
Description
Changes in glucocorticoid dose at week 12 and 24 from baseline.
Time Frame
24 weeks
Title
Adverse events during the study
Description
All adverse events, severe adverse events and proportion of patients who discontinued bortezomib due to adverse events from the first dose of bortezomib to 4 weeks after the last dose.
Time Frame
28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Other conditions that not suitable for inclusion in the study, assessed by the investigators.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinping Tian, MD
Phone
86-13691165939
Email
tianxp6@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qian Wang, MD
Phone
86-13681211155
Email
zhengaqian@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinping Tian, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinping Tian, MD
Phone
86-13691165939
Email
tianxp6@126.com
First Name & Middle Initial & Last Name & Degree
Qian Wang, MD
Phone
86-13681211155
Email
zhengaqian@sina.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Bortezomib for the Treatment of Refractory Rheumatoid Arthritis

We'll reach out to this number within 24 hrs