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Treatment Strategy for Patients With RA-ILD

ConditionRheumatoid Arthritis Associated Interstitial Lung Disease
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChinese SLE Treatment And Research Group

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • Methotrexate

    Drug

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

Treatment groups

204 Participants
are divided into 3 treatment groups
Group A: Tocilizumab groupExperimental treatment 1 intervention
Group B: Rituximab groupExperimental treatment 1 intervention
Group C: Methotrexate groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in FVC from baseline to week 52

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

Time frame
week 52±2

Secondary outcomes

1

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.

Time frame
Up to Week 52 (±2 Weeks)
2

Change in FVC % Predicted from Baseline

Change in Percent Predicted Forced Vital Capacity (FVC % Predicted) from baseline to week 52 (±2).

Time frame
Baseline to Week 52 (±2)
3

Change in DLCO from Baseline

Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) from Baseline.

Time frame
Baseline to Week 52 (±2 Weeks)
4

Change in DLCO % Predicted from Baseline

Change in Percent Predicted Diffusing Capacity of the Lung for Carbon Monoxide (DLCO % Predicted) from Baseline

Time frame
Baseline to Week 52 (±2 Weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese SLE Treatment And Research Group

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: