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New trial aims to find best treatment for lung complication in rheumatoid arthritis

NCT ID NCT07643038

Disease control Sponsor: Chinese SLE Treatment And Research Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This 52-week study will compare three drugs—tocilizumab, telitacicept, and methotrexate—in 204 people with rheumatoid arthritis who also have interstitial lung disease. The main goal is to see which drug best improves lung function. Participants will continue their usual arthritis medications during the trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tocilizumab, telitacicept, and methotrexate
What this could lead to
If successful, this trial could identify a better treatment option for people with rheumatoid arthritis who also have lung disease, potentially slowing lung damage and improving breathing.
What could go wrong
This is a phase 4 study, so the drugs are already approved for other uses, but their effectiveness for this specific lung condition is unproven. The trial is not yet recruiting, and results may show no clear benefit or unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 204 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis-associated interstitial lung disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rheumatoid arthritis associated interstitial lung disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, China

  • Affiliated Hospital of Yan'an University

    Yan’an, China

  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing, China

  • China-Japan Friendship Hospital

    Beijing, China

  • China-Japan Union Hospital of Jilin University

    Changchun, China

  • Handan Central Hospital

    Handan, China

  • Jiujiang No. 1 People's Hospital

    Jiujiang, China

  • Peking Union Medical College Hospital

    Beijing, China

  • People's Hospital of Ningxia Hui Autonomous Region

    Yinchuan, China

  • Shanxi Bethune Hospital

    Taiyuan, China

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, China

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

    Chongqing, China

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, China

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, China

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, China

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, China

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian, China

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, China

  • The Second Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, China

  • The Second Hospital of Lanzhou University

    Lanzhou, China

  • Xingyi People's Hospital

    Xingyi, China

  • Xuanwu Hospital, Capital Medical University

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.