Not Yet RecruitingPhase 4

Treatment Strategy for Patients With RA-ILD

China204 participantsStarted 2026-07-01

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. * …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is still listed as 'not yet recruiting' — do you know when it's expected to open for enrollment, and would it make sense for me to start standard treatment now while we wait to see if I might be eligible?
2The trial is measuring change in FVC — forced vital capacity — over 52 weeks, which means it's tracking whether my lung function gets better, worse, or stays stable. Can you explain where my current FVC stands and what a meaningful change in either direction would look like for someone with my level of RA-ILD?
3Since this is a Phase 4 trial, does that mean the treatment being studied is already approved for use, and if so, could I potentially access it outside of the trial through standard care rather than waiting for enrollment to open?
4RA-ILD can progress at different rates in different people — given how my disease looks right now, is this a situation where waiting up to a year for trial results would be reasonable, or is my condition one where we need to act more quickly with available treatments?
5What would my commitment look like over the 52-week study period in terms of clinic visits, lung function tests, and other monitoring, and is that kind of schedule realistic given my overall health and day-to-day life?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in FVC from baseline to week 52

Timeframe: week 52±2

Trial details

NCT IDNCT07643038

SponsorChinese SLE Treatment And Research Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-07-31

Contact for this trial

Xinping Tian

+86-13691165939 tianxp6@126.com

View on ClinicalTrials.gov More Rheumatoid Arthritis Associated Interstitial Lung Disease trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.