Telitacicept for the Treatment of Refractory RA

NCT07008196 | Not Yet Recruiting Phase 4

• 1 other identifier: Telitacicept-RA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis (RA)

Keywords

Rheumatoid Arthritis; refractory; Telitacicept

Outcome Measures

Primary Outcomes (1)

• 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)).

  Week 12

Secondary Outcomes (8)

• ACR20 at week 24

  Week 24

• The proportion of patients achieving DAS28 remission or low disease activity at week 12 and week 24

  Week 12 and 24

• The proportion of patients achieving SDAI remission or low disease activity at week 12 and week 24

  Week 12 and 24

• ACR50 at week 12 and 24

  Week 12 and 24

• ACR70 at week 12 and 24

  Week 12 and 24

Study Arms (1)

Telitacicept treatment group

EXPERIMENTAL

Telitacicept added on previous treatment

Drug: Telitacicept

Interventions

Telitacicept DRUG

Telitacicept 160mg qw subcutaneous injection

Telitacicept treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Chinese SLE Treatment And Research Group: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

telitacicept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Xinping Tian, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinping Tian, MD

CONTACT

86-13691165939; tianxp6@126.com

Qian Wang, MD

CONTACT

86-13681211155; wangqian_pumch@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of medicine

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 6, 2025
• Study Start: June 10, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)