TelitaciceptNCT06979271
Efficacy and Safety of Telitacicept Combined With Tofacitinib for Refractory Rheumatoid Arthritis
An observational study of Telitacicept and Treatment Compliance, run by Zhejiang Provincial People's Hospital at 1 site in China.
Trial summary
The aim of this study is to observe the clinical efficacy and safety of telitacicept combined with tofacitinib in the treatment of D2TRA patients Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Telitacicept, Treatment Compliance, Rheumatoid Arthritis
- What is being tested?
- Telitacicept Tofacitinib
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- Adult, Older adult
Study population: Patients with refractory rheumatoid arthritis
Who may be able to join
- Age 18-85 years
- Diagnosed with refractory rheumatoid arthritis according to the 2021 EULAR (European Alliance of Associations for Rheumatology) diagnostic criteria
- The traditional disease-improving rheumatic drug treatment is ineffective, and the use of two or more biological/targeted disease-improving anti-rheumatic drugs is ineffective, and telitacicept combined with tofacitinib is required treated patients
- Voluntarily provided written informed consent -
Who cannot join
- Exclusion of patients with severe diseases of major organs (e.g., heart, liver, or lungs)
- Patients with malignancies, hematological disorders, or other autoimmune diseases (excluding rheumatoid arthritis)
- History of allergy/hypersensitivity to the study medications (Telitacicept or Tofacitinib)
- Active tuberculosis or active infectious diseases requiring systemic treatment
- Pregnancy, lactation, or refusal to use contraception during the study
- Failure to complete the prescribed Telitacicept + Tofacitinib regimen due to: Non-adherence or Severe adverse reactions
- Other conditions contraindicating participation per investigator judgment -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310000
Zhenhua Ying, +86-571-3989897128, yingzh2021@163.com
Zhenhua Ying
About this study
Official title: Clinical Efficacy and Safety of Real-world Patients With Refractory Rheumatoid Arthritis (D2TRA) Receiving Telitacicept in Combination With Tofacitinib
The aim of this study is to observe the clinical efficacy and safety of telitacicept combined with tofacitinib in the treatment of D2TRA patients
- Conditions
- Telitacicept, Treatment Compliance, Rheumatoid Arthritis
- Being tested
- Telitacicept Tofacitinib
- Medical subject headings
- Patient Compliance, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telitacicept TofacitinibDrug
One group of D2TRA subjects receive Telitacicept combine Tofacitinib treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Telitacicept Combined With Tofacitinib for Refractory Rheumatoid Arthritis
The disease activity score of 28 joints with erythrocyte sedimentation rate (DAS28-ESR ≤ 2.6, remission; 2.6 < DAS28-ESR ≤ 3.2, mild activity; 3.2 < DAS28-ESR ≤ 5.1, moderate activity, and DAS28-ESR > 5.1, severe activity)
Measured: maximum 1 years
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse EventsArthritis
Liver and kidney function
Measured: maximum 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TelitaciceptStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenhua Ying, Zhejiang Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979271
- Sponsor's protocol ID
- KT2025024
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 18 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data
Publications
Zeng L, Yang K, Wu Y, Yu G, Yan Y, Hao M, Song T, Li Y, Chen J, Sun L. Telitacicept: A novel horizon in targeting autoimmunity and rheumatic diseases. J Autoimmun. 2024 Sep;148:103291. doi: 10.1016/j.jaut.2024.103291. Epub 2024 Aug 14.
PubMed 39146891
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety of Real-world Patients With Refractory Rheumatoid Arthritis (D2TRA) Receiving Telitacicept in Combination With Tofacitinib
- ClinicalTrials.gov ID
- NCT06979271
- Acronym / sponsor ID
- KT2025024
- Conditions
- Telitacicept, Treatment Compliance, Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 18 May 2025 (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.
The aim of this study is to observe the clinical efficacy and safety of telitacicept combined with tofacitinib in the treatment of D2TRA patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with refractory rheumatoid arthritis
Key inclusion criteria (4 listed)
- Age 18-85 years
- Diagnosed with refractory rheumatoid arthritis according to the 2021 EULAR (European Alliance of Associations for Rheumatology) diagnostic criteria
- The traditional disease-improving rheumatic drug treatment is ineffective, and the use of two or more biological/targeted disease-improving anti-rheumatic drugs is ineffective, and telitacicept combined with tofacitinib is required treated patients
- Voluntarily provided written informed consent -
Key exclusion criteria (7 listed)
- Exclusion of patients with severe diseases of major organs (e.g., heart, liver, or lungs)
- Patients with malignancies, hematological disorders, or other autoimmune diseases (excluding rheumatoid arthritis)
- History of allergy/hypersensitivity to the study medications (Telitacicept or Tofacitinib)
- Active tuberculosis or active infectious diseases requiring systemic treatment
- Pregnancy, lactation, or refusal to use contraception during 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 |
|---|---|---|
| Telitacicept TofacitinibOne group of D2TRA subjects receive Telitacicept combine Tofacitinib treatment | Drug | – |
Primary outcome
Efficacy of Telitacicept Combined With Tofacitinib for Refractory Rheumatoid Arthritis
Time frame: maximum 1 years
The disease activity score of 28 joints with erythrocyte sedimentation rate (DAS28-ESR ≤ 2.6, remission; 2.6 < DAS28-ESR ≤ 3.2, mild activity; 3.2 < DAS28-ESR ≤ 5.1, moderate activity, and DAS28-ESR > 5.1, severe activity)
1 secondary outcome
Incidence of Treatment-Emergent Adverse EventsArthritis
Time frame: maximum 1 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Results publication: PubMed 39146891Zeng L, Yang K, Wu Y, Yu G, Yan Y, Hao M, Song T, Li Y, Chen J, Sun L. Telitacicept: A novel horizon in targeting autoimmunity and rheumatic diseases. J Autoimmun. 2024 Sep;148:103291. doi: 10.1016/j.jaut.2024.103291. Epub 2024 Aug 14.
- Individual participant dataSharing planned: No. No plan to share data
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Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease
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Active, not recruitingPhase 3
A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (UPSTREAM MG)
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Clinical Efficacy of Telitacicept in Sjögren's Disease With Interstitial Lung Disease
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RecruitingPhase 2
Efficacy and Safety of Telitacicept in the Treatment of Refractory Rheumatoid Arthritis
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Telitacicept and Treatment Compliance, run by Zhejiang Provincial People's Hospital 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 18 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Telitacicept Combined With Tofacitinib for Refractory Rheumatoid Arthritis (time frame: maximum 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06979271, which also lists 1 linked publication.
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 18 May 2025.