Rheumatoid Arthritis Associated Interstitial Lung DiseasePhase 4NCT07643038
Treatment Strategy for Patients With RA-ILD
A Phase 4 study testing Tocilizumab, Rituximab (RTX) and Methotrexate in people with Rheumatoid Arthritis Associated Interstitial Lung Disease, run by Chinese SLE Treatment And Research Group at 22 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis Associated Interstitial Lung Disease
- What is being tested?
- Tocilizumab, Rituximab (RTX) and Methotrexate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 22 sitesChina
- Study dates
- 20 Sep 2026to 31 Jul 2029
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 11Show fewer
- 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.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
China22 sites
Beijing Chao-Yang Hospital, Capital Medical University
Beijing
Juan Meng
Juan Meng
China-Japan Friendship Hospital
Beijing
Xin Lu
Xin Lu
Peking Union Medical College Hospital
Beijing
Shangyi Jin, +86-13671049688, jinjinboli@sina.com
Xinping Tian
Xuanwu Hospital, Capital Medical University
Beijing
Yi Zhao
Yi Zhao
China-Japan Union Hospital of Jilin University
Changchun
The First Affiliated Hospital of Army Medical University (Southwest Hospital)
Chongqing
Qinghua Zou
Qinghua Zou
The Second Affiliated Hospital of Dalian Medical University
Dalian
Xiaodan Kong
Xiaodan Kong
Handan Central Hospital
Handan
Xi Liu
Xi Liu
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Jing Xue
Jing Xue
The First Affiliated Hospital of Anhui Medical University
Hefei
Shengqian Xu
Shengqian Xu
Affiliated Hospital of Inner Mongolia Medical University
Hohhot
Hongbin Li
Hongbin Li
Jiujiang No. 1 People's Hospital
Jiujiang
Ju Liu
Ju Liu
The Second Hospital of Lanzhou University
Lanzhou
Haili Shen
Haili Shen
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
Xiaofei Shi
Xiaofei Shi
The Second Affiliated Hospital of Nanchang University
Nanchang
Xinwang Duan
Xinwang Duan
The First Affiliated Hospital of Nanjing Medical University
Nanjing
Wenfeng Tan
Wenfeng Tan
The First Affiliated Hospital of Guangxi Medical University
Nanning
Ling Lei
Ling Lei
Shanxi Bethune Hospital
Taiyuan
Liyun Zhang
Liyun Zhang
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi
Li Luo
Li Luo
Xingyi People's Hospital
Xingyi
Houli Liao
Houli Liao
Affiliated Hospital of Yan'an University
Yan’an
Yuhong Liu
Yuhong Liu
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan
Donggeng Guo
Donggeng Guo
About this study
Official title: 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.
Read the 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.
- Being tested
- Tocilizumab, Rituximab (RTX), Methotrexate
- Keywords
- randomized controlled trial, Tocilizumab, rituximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
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.
Rituximab (RTX)Drug
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.
MethotrexateDrug
Methotrexate will be administered orally at a dose of 15 mg once weekly in addition to stable background csDMARD therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tocilizumab |
| Rituximab group | Experimental | 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. Receives: Drug: Rituximab (RTX) |
| 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. Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FVC from baseline to week 52
Change in Forced Vital Capacity (FVC) from Baseline to Week 52 (±2 Weeks)
Measured: week 52±2
Secondary outcomes (6)
Proportion of Participants Experiencing a Composite Clinical Endpoint
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.
Measured: Up to Week 52 (±2 Weeks)
Change in FVC % Predicted from Baseline
Change in Percent Predicted Forced Vital Capacity (FVC % Predicted) from baseline to week 52 (±2).
Measured: Baseline to Week 52 (±2)
Change in DLCO from Baseline
Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) from Baseline.
Measured: Baseline to Week 52 (±2 Weeks)
Change in DLCO % Predicted from Baseline
Change in Percent Predicted Diffusing Capacity of the Lung for Carbon Monoxide (DLCO % Predicted) from Baseline
Measured: Baseline to Week 52 (±2 Weeks)
Change in Chest HRCT Score from Baseline
Change in the total chest high-resolution computed tomography (HRCT) score, inflammatory activity score, and fibrosis score.
Measured: Baseline to Week 52 (±2 Weeks)
Change in mMRC Dyspnea Scale Score from Baseline
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.
Measured: Baseline to Week 52 (±2 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start20 Sep 2026 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis Associated Interstitial Lung DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese SLE Treatment And Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinping Tian, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643038
- Sponsor's protocol ID
- Strategy on RA-ILD
- Status last verified
- Sep 2026
- First submitted
- 7 Jun 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Strategy for Patients With Rheumatoid Arthritis Associated Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT07643038
- Acronym / sponsor ID
- Strategy on RA-ILD
- Keywords
- randomized controlled trial, Tocilizumab, rituximab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Chinese SLE Treatment And Research GroupUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 11 Jun 2026 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab group | Experimental | Drug: TocilizumabTocilizumab will be administered intravenously at a dose of 8 mg/kg every 4 weeks for 52 weeks in combination with csDMARD. |
| Rituximab group | Experimental | Drug: Rituximab (RTX)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. |
| Methotrexate group | Active comparator | Drug: MethotrexateMethotrexate will be administered orally at a dose of 15 mg once weekly for 52 weeks in combination with stable background immunosuppressive therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| TocilizumabTocilizumab 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. | Drug | Tocilizumab group |
| 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. | Drug | Rituximab group |
| MethotrexateMethotrexate will be administered orally at a dose of 15 mg once weekly in addition to stable background csDMARD therapy | Drug | Methotrexate group |
Primary outcome
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)
6 secondary outcomes
Proportion of Participants Experiencing a Composite Clinical Endpoint
Time frame: Up to Week 52 (±2 Weeks)
Change in FVC % Predicted from Baseline
Time frame: Baseline to Week 52 (±2)
Change in DLCO from Baseline
Time frame: Baseline to Week 52 (±2 Weeks)
Change in DLCO % Predicted from Baseline
Time frame: Baseline to Week 52 (±2 Weeks)
Change in Chest HRCT Score from Baseline
Time frame: Baseline to Week 52 (±2 Weeks)
Change in mMRC Dyspnea Scale Score from Baseline
Time frame: Baseline to Week 52 (±2 Weeks)
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 3 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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 principal investigator
Peking Union Medical College Hospital
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tocilizumab, Rituximab (RTX) and Methotrexate in people with Rheumatoid Arthritis Associated Interstitial Lung Disease, run by Chinese SLE Treatment And Research Group at 22 sites 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 6 inclusion and 11 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 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites 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 (+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?
Change in FVC from baseline to week 52 (time frame: week 52±2). 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 3 Sep 2026.