Treatment Strategy for Patients With RA-ILD

September 1, 2026 updated by: Chinese SLE Treatment And Research Group

Treatment Strategy for Patients With Rheumatoid Arthritis Associated Interstitial Lung Disease

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a multicenter, randomized, controlled clinical trial designed to evaluate the efficacy and safety of tocilizumab and rituximab in patients with rheumatoid arthritis-associated interstitial lung disease (RA-ILD). A total of 204 eligible participants will be enrolled from 20 centers across China and randomly assigned in a 1:1:1 ratio to one of three treatment arms: (1) tocilizumab in combination with conventional disease-modifying antirheumatic drugs (cDMARDs); (2) rituximab in combination with cDMARDs; or (3) methotrexate added to the participant's pre-existing background immunosuppressive regimen. Each treatment arm will include 68 participants. Participants will be assessed at baseline and at Weeks 4, 12, 24, and 52 following treatment initiation. Efficacy and safety data will be collected throughout the study to evaluate treatment response and tolerability. Safety assessments will include the incidence of adverse events (AEs), serious adverse events (SAEs), treatment discontinuations due to AEs or SAEs, and other clinically relevant safety outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
204

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Peking Union Medical College Hospital
        • Principal Investigator:
          • Xinping Tian
        • Contact:
      • Beijing, China
        • China-Japan Friendship Hospital
        • Principal Investigator:
          • Xin Lu
        • Contact:
          • Xin Lu
      • Beijing, China
        • Xuanwu Hospital, Capital Medical University
        • Contact:
          • Yi Zhao
        • Principal Investigator:
          • Yi Zhao
      • Beijing, China
        • Beijing Chao-Yang Hospital, Capital Medical University
        • Contact:
          • Juan Meng
        • Principal Investigator:
          • Juan Meng
      • Changchun, China
        • China-Japan Union Hospital of Jilin University
      • Chongqing, China
        • The First Affiliated Hospital of Army Medical University (Southwest Hospital)
        • Contact:
          • Qinghua Zou
        • Principal Investigator:
          • Qinghua Zou
      • Dalian, China
        • The Second Affiliated Hospital of Dalian Medical University
        • Contact:
          • Xiaodan Kong
        • Principal Investigator:
          • Xiaodan Kong
      • Handan, China
        • Handan Central Hospital
        • Contact:
          • Xi Liu
        • Principal Investigator:
          • Xi Liu
      • Hangzhou, China
        • The Second Affiliated Hospital, Zhejiang University School of Medicine
        • Principal Investigator:
          • Jing Xue
        • Contact:
          • Jing Xue
      • Hefei, China
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
          • Shengqian Xu
        • Principal Investigator:
          • Shengqian Xu
      • Hohhot, China
        • Affiliated Hospital of Inner Mongolia Medical University
        • Contact:
          • Hongbin Li
        • Principal Investigator:
          • Hongbin Li
      • Jiujiang, China
        • Jiujiang No. 1 People's Hospital
        • Contact:
          • Ju Liu
        • Principal Investigator:
          • Ju Liu
      • Lanzhou, China
        • The Second Hospital of Lanzhou University
        • Contact:
          • Haili Shen
        • Principal Investigator:
          • Haili Shen
      • Nanchang, China
        • The Second Affiliated Hospital of Nanchang University
        • Principal Investigator:
          • Xinwang Duan
        • Contact:
          • Xinwang Duan
      • Nanjing, China
        • The First Affiliated Hospital of Nanjing Medical University
        • Principal Investigator:
          • Wenfeng Tan
        • Contact:
          • Wenfeng Tan
      • Nanning, China
        • The First Affiliated Hospital of Guangxi Medical University
        • Principal Investigator:
          • Ling Lei
        • Contact:
          • Ling Lei
      • Taiyuan, China
        • Shanxi Bethune Hospital
        • Contact:
          • Liyun Zhang
        • Principal Investigator:
          • Liyun Zhang
      • Xingyi, China
        • Xingyi People's Hospital
        • Contact:
          • Houli Liao
        • Principal Investigator:
          • Houli Liao
      • Yan’an, China
        • Affiliated Hospital of Yan'an University
        • Contact:
          • Yuhong Liu
        • Principal Investigator:
          • Yuhong Liu
      • Yinchuan, China
        • People's Hospital of Ningxia Hui Autonomous Region
        • Contact:
          • Donggeng Guo
        • Principal Investigator:
          • Donggeng Guo
      • Ürümqi, China
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:
          • Li Luo
        • Principal Investigator:
          • Li Luo
    • Henan
      • Luoyang, Henan, China
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Principal Investigator:
          • Xiaofei Shi
        • Contact:
          • Xiaofei Shi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tocilizumab group
Tocilizumab will be administered intravenously at a dose of 8 mg/kg every 4 weeks for 52 weeks in combination with csDMARD.
Drug: Tocilizumab
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.
Active Comparator: Methotrexate group
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
Methotrexate will be administered orally at a dose of 15 mg once weekly in addition to stable background csDMARD therapy
Experimental: Rituximab group
Rituximab will be administered by intravenous infusion at a dose of 1000 mg on Day 0, 1000 mg at Week 2, 500 mg at Week 26, and 500 mg at Week 52, in addition to ongoing treatment with csDMARDs.
Drug: Rituximab (RTX)
Rituximab will be administered intravenously at a dose of 1,000 mg on Day 0, 1,000 mg at Week 2, 500 mg at Week 26, and 500 mg at Week 52, in addition to stable background csDMARD therapy maintained throughout the study period.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in FVC from baseline to week 52
Time Frame: week 52±2
Change in Forced Vital Capacity (FVC) from Baseline to Week 52 (±2 Weeks)
week 52±2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of Participants Experiencing a Composite Clinical Endpoint
Time Frame: Up to Week 52 (±2 Weeks)
Composite clinical endpoint defined as the occurrence of at least one of the following events: all-cause mortality, hospitalization for any cause, hospitalization due to progression of respiratory disease, or death due to progression of respiratory disease.
Up to Week 52 (±2 Weeks)
Change in FVC % Predicted from Baseline
Time Frame: Baseline to Week 52 (±2)
Change in Percent Predicted Forced Vital Capacity (FVC % Predicted) from baseline to week 52 (±2).
Baseline to Week 52 (±2)
Change in DLCO from Baseline
Time Frame: Baseline to Week 52 (±2 Weeks)
Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) from Baseline.
Baseline to Week 52 (±2 Weeks)
Change in DLCO % Predicted from Baseline
Time Frame: Baseline to Week 52 (±2 Weeks)
Change in Percent Predicted Diffusing Capacity of the Lung for Carbon Monoxide (DLCO % Predicted) from Baseline
Baseline to Week 52 (±2 Weeks)
Change in Chest HRCT Score from Baseline
Time Frame: Baseline to Week 52 (±2 Weeks)
Change in the total chest high-resolution computed tomography (HRCT) score, inflammatory activity score, and fibrosis score.
Baseline to Week 52 (±2 Weeks)
Change in mMRC Dyspnea Scale Score from Baseline
Time Frame: Baseline to Week 52 (±2 Weeks)
Change in Modified Medical Research Council (mMRC) Dyspnea Scale Score from Baseline to Week 52 (±2). The mMRC Dyspnea Scale is scored from 0 to 4, with higher scores indicating more severe dyspnea.
Baseline to Week 52 (±2 Weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese SLE Treatment And Research Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xinping Tian, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Strategy on RA-ILD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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