Treatment Strategy for Patients With RA-ILD

NCT07643038 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: Strategy on RA-ILD
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 22

Brief Summary

This is a 52-week, multicenter, prospective, open-label, randomized controlled clinical study, comparing the efficacy and safety of tocilizumab, telitacicept, and csDMARD methotrexate in patients with RA-ILD.

Conditions

Rheumatoid Arthritis Associated Interstitial Lung Disease

Keywords

randomized controlled trial; Telitacicept; Tocilizumab

Outcome Measures

Primary Outcomes (1)

• Change in FVC from baseline to week 52

  Change in Forced Vital Capacity (FVC) from Baseline to Week 52 (±2 Weeks)

  week 52±2

Secondary Outcomes (6)

• Proportion of Participants Experiencing a Composite Clinical Endpoint

  Up to Week 52 (±2 Weeks)

• Change in FVC % Predicted from Baseline

  Baseline to Week 52 (±2)

• Change in DLCO from Baseline

  Baseline to Week 52 (±2 Weeks)

• Change in DLCO % Predicted from Baseline

  Baseline to Week 52 (±2 Weeks)

• Change in Chest HRCT Score from Baseline

  Baseline to Week 52 (±2 Weeks)

Study Arms (3)

Tocilizumab group

EXPERIMENTAL

Tocilizumab will be administered intravenously at a dose of 8 mg/kg every 4 weeks for 52 weeks in combination with csDMARD.

Drug: Tocilizumab

Telitacicept group

EXPERIMENTAL

Telitacicept will be administered by subcutaneous injection at a dose of 160 mg once weekly for 52 weeks in combination with csDMARD.

Drug: Telitacicept

Methotrexate group

ACTIVE COMPARATOR

Methotrexate will be administered orally at a dose of 15 mg once weekly for 52 weeks in combination with stable background immunosuppressive therapy.

Drug: Methotrexate

Interventions

Tocilizumab DRUG

Tocilizumab will be administered intravenously at a dose of 8 mg/kg every 4 weeks in addition to stable background csDMARD therapy maintained throughout the study period.

Tocilizumab group

Methotrexate DRUG

Methotrexate will be administered orally at a dose of 15 mg once weekly in addition to stable background csDMARD therapy

Methotrexate group

Telitacicept DRUG

Telitacicept will be administered by subcutaneous injection at a dose of 160 mg once weekly in addition to stable background csDMARD therapy maintained throughout the study period

Telitacicept group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fulfillment of the 2010 ACR/EULAR classification criteria for RA.
• HRCT findings consistent with interstitial lung disease (ILD), including ground-glass opacities, reticular abnormalities, fibrotic linear opacities, traction bronchiectasis, or other compatible features, with pulmonary infection, cardiogenic pulmonary edema, and alveolar hemorrhage excluded. The extent of ILD involvement must be ≥20% on HRCT, as assessed by central review.
• Pulmonary function impairment defined as forced vital capacity (FVC) \<80% of predicted and/or diffusing capacity of the lung for carbon monoxide (DLCO) \<70% of predicted.
• Participants receiving glucocorticoids prior to enrollment must be on a stable dose of prednisone ≤10 mg/day (or equivalent) for at least 4 weeks before baseline.
• Participants receiving a csDMARD prior to enrollment must be on a stable regimen for at least 4 weeks before baseline.
• Able and willing to provide written informed consent and comply with study requirements, including scheduled visits and follow-up assessments.

You may not qualify if:

• Presence of other autoimmune diseases.
• Presence of severe, uncontrolled clinically significant organ dysfunction or other medical conditions that, in the investigator's judgment, would place the participant at unacceptable risk.
• History of malignancy within 5 years prior to screening.
• Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study period.
• Known hypersensitivity to tocilizumab, telitacicept, methotrexate, or any of their excipients.
• Active hepatitis B or C virus infection, active tuberculosis, active herpes zoster infection, or a history of serious infection within 12 weeks prior to study treatment initiation (defined as an infection requiring hospitalization or intravenous antimicrobial therapy).
• Severe hypoalbuminemia or serum immunoglobulin G (IgG) level \<6 g/L.
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 × the upper limit of normal (ULN), total bilirubin \>1.5 × ULN, or creatinine clearance (CrCl) \<60 mL/min.
• Participation in another interventional clinical trial within 4 weeks prior to screening.
• Inability to adequately perform pulmonary function testing or other study-related assessments.
• Any other condition that, in the opinion of the investigator, would make the participant unsuitable for participation in this study.

Sponsors & Collaborators

• Chinese SLE Treatment And Research Group: lead

Study Sites (22)

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Location

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, China

Location

China-Japan Friendship Hospital

Beijing, China

Location

Peking Union Medical College Hospital

Beijing, China

Location

Xuanwu Hospital, Capital Medical University

Beijing, China

Location

China-Japan Union Hospital of Jilin University

Changchun, China

Location

The First Affiliated Hospital of Army Medical University (Southwest Hospital)

Chongqing, China

Location

The Second Affiliated Hospital of Dalian Medical University

Dalian, China

Location

Handan Central Hospital

Handan, China

Location

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

Location

The First Affiliated Hospital of Anhui Medical University

Hefei, China

Location

Affiliated Hospital of Inner Mongolia Medical University

Hohhot, China

Location

Jiujiang No. 1 People's Hospital

Jiujiang, China

Location

The Second Hospital of Lanzhou University

Lanzhou, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, China

Location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, China

Location

Shanxi Bethune Hospital

Taiyuan, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, China

Location

Xingyi People's Hospital

Xingyi, China

Location

Affiliated Hospital of Yan'an University

Yan’an, China

Location

People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, China

Location

MeSH Terms

Interventions

tocilizumab; telitacicept; Methotrexate

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Xinping Tian

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinping Tian

CONTACT

+86-13691165939; tianxp6@126.com

Shangyi Jin

CONTACT

+86-1367049688; jinjinboli@sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2026
• First Posted: June 11, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

CN (22)