Rheumatoid ArthritisNCT05805891
Bortezomib for the Treatment of Refractory Rheumatoid Arthritis
A study testing bortezomib in people with Rheumatoid Arthritis, run by Chinese SLE Treatment And Research Group at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- bortezomib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Dec 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Xinping Tian, MD, 86-13691165939, tianxp6@126.com
Qian Wang, MD, 86-13681211155, zhengaqian@sina.com
About this study
Official title: An Exploratory Clinical Study on Bortezomib for the Treatment of Refractory Rheumatoid Arthritis
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- bortezomib
- Keywords
- rheumatoid arthritis, bortezomib
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomibDrug
bortezomib 2mg/week subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| bortezomib | Experimental | bortezomib added on previous treatment Receives: Drug: bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (6)
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.
Measured: 12 weeks
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.
Measured: 24 weeks
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.
Measured: 24 weeks
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.
Measured: 24 weeks
Changes in glucocorticoid dose
Changes in glucocorticoid dose at week 12 and 24 from baseline.
Measured: 24 weeks
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.
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study startDec 2023 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese SLE Treatment And Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinping Tian, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805891
- Sponsor's protocol ID
- Bortezomib-RA
- Status last verified
- Mar 2023
- First submitted
- 22 Mar 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study on Bortezomib for the Treatment of Refractory Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT05805891
- Acronym / sponsor ID
- Bortezomib-RA
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, bortezomib
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chinese SLE Treatment And Research GroupUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bortezomib | Experimental | Drug: bortezomibbortezomib added on previous treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bortezomibbortezomib 2mg/week subcutaneous injection | Drug | bortezomib |
Primary outcome
DAS28 remission or LDA at week 24
Time frame: 24 weeks
Proportion of patients who achieve remission or low disease activity (LDA) at week 24 according to DAS 28.
6 secondary outcomes
DAS28 improvement at week 12
Time frame: 12 weeks
SDAI improvement at week 12 and remission or LDA at week 24
Time frame: 24 weeks
CDAI improvement at week 12 and remission or LDA at week 24
Time frame: 24 weeks
ACR20, ACR50 and ACR70 at week 12 and week 24
Time frame: 24 weeks
Changes in glucocorticoid dose
Time frame: 24 weeks
Adverse events during the study
Time frame: 28 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xinping Tian, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bortezomib in people with Rheumatoid Arthritis, run by Chinese SLE Treatment And Research Group at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinping Tian, MD (86-13691165939, tianxp6@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DAS28 remission or LDA at week 24 (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.