Rheumatoid Arthritis (RA)Phase 4NCT07008196
Telitacicept for the Treatment of Refractory RA
A Phase 4 study testing Telitacicept in people with Rheumatoid Arthritis (RA), run by Chinese SLE Treatment And Research Group at 1 site in China.
Trial summary
This is a single-center, single-arm, open-label, prospective study on the efficacy and safety of Telitacicept 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 (RA)
- What is being tested?
- Telitacicept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2025to Jan 2026
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfill the classification criteria of the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR)
- Refractory RA definition: Insufficient response to a combination of at least two adequate doses of csDMARDs followed by bDMARDs (including but not limited to tumor necrosis factor inhibitors, interleukin-6 receptor inhibitors, T-cell costimulation molecule inhibitors, B-cell targeted drugs) or tsDMARDs (including but not limited to JAK inhibitors) for 12 weeks, with stable drug dosage for at least 6 weeks
- For patients treated with glucocorticoid therapy, they must have been on a stable dose of prednisone or prednisone equivalent ≤ 10 mg/day for at least 4 weeks before enrollment
- For patients treated with non-steroidal anti-inflammatory drugs, they must have been on a stable dose for at least 2 weeks before screening and enrollment
- ① Age > 18 years and < 70 years; ② Absolute neutrophil count ≥ 1.0 × 10⁹/L, platelet count ≥ 100 × 10⁹/L, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within 3 times the upper limit of normal, total bilirubin within 1.5 times the upper limit of normal, serum creatinine clearance rate > 60 ml/min; ③ Voluntarily sign the informed consent form
Who cannot join
- Subjects with other autoimmune diseases
- Subjects with severe and poorly controlled cardiovascular, cerebrovascular, respiratory, liver, kidney, gastrointestinal, endocrine, hematological, or neurological diseases, or laboratory abnormalities that, in the opinion of the investigator, pose unacceptable risks for participation in the study
- Subjects with a history of malignancy (or less than 5 years since clinical remission)
- Subjects who are pregnant or breastfeeding, or plan to become pregnant or start breastfeeding during the study period
- Subjects who have received live virus vaccines within 4 weeks prior to enrollment in the study
- Subjects allergic to talizumab or any excipients
Show all 10Show fewer
- Subjects who have participated in any other investigational drug trial within 12 weeks prior to the start of this study
- Subjects with active hepatitis or a history of severe liver disease at screening
- Subjects in the active phase of herpes zoster infection, or those who have experienced severe infections (requiring intravenous antibiotics or hospitalization) within 12 weeks prior to the start of the study medication
- Subjects with other conditions deemed unsuitable for enrollment by the investigator
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
Peking Union Medical College Hospital
Beijing, 100730
Xinping Tian, MD, 86-13691165939, tianxp6@126.com
About this study
Official title: An Exploratory Clinical Study on Telitacicept for the Treatment of Refractory Rheumatoid Arthritis
This is a single-center, single-arm, open-label, prospective study on the efficacy and safety of Telitacicept in patients with refractory rheumatoid arthritis.
Read the detailed description
The treatment of rheumatoid arthritis (RA) has made significant progress over the past three decades. However, approximately 20-30% of patients remain resistant to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), biologic DMARDs (bDMARDs), and targeted synthetic DMARDs (tsDMARDs), presenting a major challenge in RA management. Telitacicept is a dual-target inhibitor of B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL). By inhibiting B cell maturation, differentiation, and antibody secretion by plasma cells, it reduces autoantibody production and the release of pro-inflammatory cytokines such as Tumor necrosis factor-α (TNF-α) and Interleukin-6 (IL-6), thereby alleviating joint inflammation. Clinically, a Phase III study of telitacicept in RA patients with inadequate response to methotrexate demonstrated a rapid onset of action within 4 weeks. At week 24, the ACR20 response rate in the 160 mg telitacicept group reached 67.4%, and at week 48, the response rate increased to 72.2%. Nearly 90% of patients exhibited no radiographic progression. In terms of safety, the incidence of adverse events with telitacicept was comparable to that of conventional therapies.
Currently, there are no clinical trials or registered studies investigating the use of telitacicept in the treatment of refractory RA. This study aims to evaluate the efficacy and safety of telitacicept in patients with refractory rheumatoid arthritis.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- Telitacicept
- Keywords
- Rheumatoid Arthritis, refractory, Telitacicept
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelitaciceptDrug
Telitacicept 160mg qw subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Telitacicept treatment group | Experimental | Telitacicept added on previous treatment Receives: Drug: Telitacicept |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR20 at week 12
ACR20 is a comprehensive index defined as an improvement of at least 20% in both the number of tender and swollen joints, and improvement in at least three of the following five parameters by at least 20%: 1) Visual Analogue Scale (VAS) for pain, 2) patient's global assessment, 3) physician's global assessment, 4) Health Assessment Questionnaire (HAQ), and 5) acute-phase reactants (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)).
Measured: Week 12
Secondary outcomes (8)
ACR20 at week 24
ACR20 is a comprehensive index defined as an improvement of at least 20% in both the number of tender and swollen joints, and improvement in at least three of the following five parameters by at least 20%: 1) Visual Analogue Scale (VAS) for pain, 2) patient's global assessment, 3) physician's global assessment, 4) Health Assessment Questionnaire (HAQ), and 5) acute-phase reactants (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)).
Measured: Week 24
The proportion of patients achieving DAS28 remission or low disease activity at week 12 and week 24
DAS28 evaluates RA severity by quantifying joint inflammation and systemic markers of disease activity.
Measured: Week 12 and 24
The proportion of patients achieving SDAI remission or low disease activity at week 12 and week 24
Simplified Disease Activity Index (SDAI) is calculated by summing five parameters: Tender Joint Count (TJC28): Number of tender joints out of 28 assessed joints. Swollen Joint Count (SJC28): Number of swollen joints out of 28 assessed joints. Patient Global Assessment (PGA): Patient's self-rated health status on a 0-10 scale (0 = best, 10 = worst). Physician Global Assessment (MDGA): Physician's evaluation of disease activity on a 0-10 scale (0 = best, 10 = worst). C-reactive Protein (CRP): Laboratory value measured in mg/L.
Measured: Week 12 and 24
ACR50 at week 12 and 24
ACR50 is a comprehensive index defined as an improvement of at least 50% in both the number of tender and swollen joints, and improvement in at least three of the following five parameters by at least 50%: 1) Visual Analogue Scale (VAS) for pain, 2) patient's global assessment, 3) physician's global assessment, 4) Health Assessment Questionnaire (HAQ), and 5) acute-phase reactants (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)).
Measured: Week 12 and 24
ACR70 at week 12 and 24
ACR70 is a comprehensive index defined as an improvement of at least 70% in both the number of tender and swollen joints, and improvement in at least three of the following five parameters by at least 70%: 1) Visual Analogue Scale (VAS) for pain, 2) patient's global assessment, 3) physician's global assessment, 4) Health Assessment Questionnaire (HAQ), and 5) acute-phase reactants (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)).
Measured: Week 12 and 24
The proportion of patients achieving CDAI remission or low disease activity at week 12 and week 24
Clinical Disease Activity Index (CDAI) is a composite score used to assess disease activity in rheumatoid arthritis (RA). It calculates disease severity through the following parameters: Tender Joint Count (TJC28): Number of tender joints out of 28 assessed joints. Swollen Joint Count (SJC28): Number of swollen joints out of 28 assessed joints. Patient Global Assessment (PGA): Patient's self-rated health status on a 0-10 scale (0 = best, 10 = worst). Physician Global Assessment (MDGA): Physician's evaluation of disease activity on a 0-10 scale (0 = best, 10 = worst).
Measured: Week 12 and 24
Change in glucocorticoid dosage
Change in glucocorticoid dosage at week 24 of treatment compared to baseline
Measured: week 24
Adverse events
The incidence of all adverse events, serious adverse events, and the probability of drug discontinuation due to adverse events or serious adverse events
Measured: during the study period and within 4 weeks after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start10 Jun 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese SLE Treatment And Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinping Tian, Chinese SLE Treatment And Research Group
- Investigators
- Xinping Tian, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008196
- Sponsor's protocol ID
- Telitacicept-RA
- Status last verified
- Jun 2025
- First submitted
- 26 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study on Telitacicept for the Treatment of Refractory Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT07008196
- Acronym / sponsor ID
- Telitacicept-RA
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Rheumatoid Arthritis, refractory, Telitacicept
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese SLE Treatment And Research GroupUniversity, hospital or other
- Study start
- 10 Jun 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 6 Jun 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.
This is a single-center, single-arm, open-label, prospective study on the efficacy and safety of Telitacicept in patients with refractory rheumatoid arthritis.
Detailed description
The treatment of rheumatoid arthritis (RA) has made significant progress over the past three decades. However, approximately 20-30% of patients remain resistant to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), biologic DMARDs (bDMARDs), and targeted synthetic DMARDs (tsDMARDs), presenting a major challenge in RA management. Telitacicept is a dual-target inhibitor of B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL). By inhibiting B cell maturation, differentiation, and antibody secretion by plasma cells, it reduces autoantibody production and the release of pro-inflammatory cytokines such as Tumor necrosis factor-α (TNF-α) and Interleukin-6 (IL-6), thereby alleviating joint inflammation. Clinically, a Phase III study of telitacicept in RA patients with inadequate response to methotrexate demonstrated a rapid onset of action within 4 weeks. At week 24, the ACR20 response rate in the 160 mg telitacicept group reached 67.4%, and at week 48, the response rate increased to 72.2%. Nearly 90% of patients exhibited no radiographic progression. In terms of safety, the incidence of adverse events with telitacicept was comparable to that of conventional therapies.
Currently, there are no clinical trials or registered studies investigating the use of telitacicept in the treatment of refractory RA. This study aims to evaluate the efficacy and safety of telitacicept 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 |
|---|---|---|
| Telitacicept treatment group | Experimental | Drug: TelitaciceptTelitacicept 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 (5 listed)
- Fulfill the classification criteria of the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR)
- Refractory RA definition: Insufficient response to a combination of at least two adequate doses of csDMARDs followed by bDMARDs (including but not limited to tumor necrosis factor inhibitors, interleukin-6 receptor inhibitors, T-cell costimulation molecule inhibitors, B-cell targeted drugs) or tsDMARDs (including but not limited to JAK inhibitors) for 12 weeks, with stable drug dosage for at least 6 weeks
- For patients treated with glucocorticoid therapy, they must have been on a stable dose of prednisone or prednisone equivalent ≤ 10 mg/day for at least 4 weeks before enrollment
- For patients treated with non-steroidal anti-inflammatory drugs, they must have been on a stable dose for at least 2 weeks before screening and enrollment
- ① Age > 18 years and < 70 years; ② Absolute neutrophil count ≥ 1.0 × 10⁹/L, platelet count ≥ 100 × 10⁹/L, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within 3 times the upper limit of normal, total bilirubin within 1.5 times the upper limit of normal, serum creatinine clearance rate > 60 ml/min; ③ Voluntarily sign the informed consent form
Key exclusion criteria (10 listed)
- Subjects with other autoimmune diseases
- Subjects with severe and poorly controlled cardiovascular, cerebrovascular, respiratory, liver, kidney, gastrointestinal, endocrine, hematological, or neurological diseases, or laboratory abnormalities that, in the opinion of the investigator, pose unacceptable risks for participation in the study
- Subjects with a history of malignancy (or less than 5 years since clinical remission)
- Subjects who are pregnant or breastfeeding, or plan to become pregnant or start breastfeeding during the study period
- Subjects who have received live virus vaccines within 4 weeks prior to enrollment in 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 |
|---|---|---|
| TelitaciceptTelitacicept 160mg qw subcutaneous injection | Drug | Telitacicept treatment group |
Primary outcome
ACR20 at week 12
Time frame: Week 12
ACR20 is a comprehensive index defined as an improvement of at least 20% in both the number of tender and swollen joints, and improvement in at least three of the following five parameters by at least 20%: 1) Visual Analogue Scale (VAS) for pain, 2) patient's global assessment, 3) physician's global assessment, 4) Health Assessment Questionnaire (HAQ), and 5) acute-phase reactants (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)).
8 secondary outcomes
ACR20 at week 24
Time frame: Week 24
The proportion of patients achieving DAS28 remission or low disease activity at week 12 and week 24
Time frame: Week 12 and 24
The proportion of patients achieving SDAI remission or low disease activity at week 12 and week 24
Time frame: Week 12 and 24
ACR50 at week 12 and 24
Time frame: Week 12 and 24
ACR70 at week 12 and 24
Time frame: Week 12 and 24
The proportion of patients achieving CDAI remission or low disease activity at week 12 and week 24
Time frame: Week 12 and 24
Change in glucocorticoid dosage
Time frame: week 24
Adverse events
Time frame: during the study period and within 4 weeks after study completion
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 6 Jun 2025.
- Individual participant dataSharing planned: No
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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.
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 Phase 4 study testing Telitacicept in people with Rheumatoid Arthritis (RA), 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 5 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: opening soon, as of the sponsor's last update on 6 Jun 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
ACR20 at week 12 (time frame: Week 12). 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 6 Jun 2025.