Clinical Efficacy of Telitacicept in Sjögren's Disease With Interstitial Lung Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorPeking University People's Hospital
About this trial
This study aims to evaluate the efficacy Telitacicept in patients with primary Sjögren's Disease with interstitial lung disease
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 to 70 years, male or female.
Diagnosis of primary Sjögren's Syndrome meeting the 2016 ACR/EULAR classification criteria.
Confirmed diagnosis of Interstitial Lung Disease by High-Resolution Computed Tomography (HRCT).
Stable doses of corticosteroids and immunosuppressants (e.g., mycophenolate mofetil) for at least 1 week prior to enrollment.
Disqualifiers
Allergy: Known allergy or hypersensitivity to Telitacicept or any of its excipients.
Concomitant Autoimmune Diseases: Diagnosis of other systemic autoimmune diseases besides Sjögren's Syndrome, such as Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc), Mixed Connective Tissue Disease (MCTD), or ANCA-associated vasculitis. (Note: Secondary Sjögren's Syndrome is not excluded on this basis alone, but the primary condition must be considered).
Trial population
The study population will consist of 60 adult patients with primary Sjögren's disease and HRCT-confirmed interstitial lung disease, enrolled and allocated to treatment groups based on real-world clinical practice.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Telitacicept 160mg
DrugThe study duration was 24 weeks, with the experimental group receiving subcutaneous injections of Telitacicept once weekly for a total of 24 weeks.
Conventional treatment
DrugConventional treatment with methylprednisolone (≤ 40 mg/day) and other immunosuppressive agents (including but not limited to cyclophosphamide, tacrolimus, sirolimus, cyclosporine, leflunomide, azathioprine, mycophenolate mofetil, hydroxychloroquine, tripterygium glycosides, methotrexate, and sulfasalazine). Treatment restrictions: The use of immunosuppressants was limited to a maximum of three agents throughout the 24-week period, and dose adjustments from baseline were restricted to within 30%.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: The telitacicept group2 interventions
Group B: The control group1 intervention
Trial outcomes
Primary outcomes
1
Change From Baseline in Forced Vital Capacity Percent Predicted at Week 24
FVC will be measured using standardized pulmonary function testing and expressed as the percentage of the predicted value. The outcome will be calculated as Week 24 FVC% predicted minus baseline FVC% predicted. The adjusted between-group difference will be estimated between the telitacicept and conventional-treatment cohorts.
Time frame
At baseline and at week 12,24Secondary outcomes
1
Change From Baseline in Diffusing Capacity for Carbon Monoxide Percent Predicted at Week 24
The outcome will be calculated as Week 24 DLCO% predicted minus baseline DLCO% predicted.
Time frame
Baseline, Week 12, and Week 242
Change From Baseline in Total Lung Capacity at Week 24
Total lung capacity will be measured by standardized pulmonary function testing. Both the observed value and percent predicted, where available, will be recorded.
Time frame
Baseline, Week 12, and Week 243
Change From Baseline in HRCT Warrick Score at Week 24
HRCT abnormalities will be assessed using the Warrick scoring system. The severity score ranges from 0 to 15 and is based on five abnormalities: ground-glass opacity (1 point), irregular pleural margins (2 points), septal or subpleural lines (3 points), honeycombing (4 points), and subpleural cysts (5 points). For each abnormality, extent is scored according to the number of bronchopulmonary segments involved: 1-3 segments (1 point), 4-9 segments (2 points), and more than 9 segments (3 points), giving a total extent score of 0-15. The Warrick total score is the sum of severity and extent scores and ranges from 0 to 30, with higher scores indicating greater ILD involvement.
Time frame
Baseline and Week 244
Change From Baseline in Serum Krebs von den Lungen-6 at Week 24
Serum Krebs von den Lungen-6 (KL-6) concentration will be measured as a biomarker associated with interstitial lung disease activity and severity.
Time frame
Baseline, Week 12, and Week 24Other outcomes
1
Changes in Peripheral B-cell Subsets and Related Biomarkers
Changes from baseline in total B cells, B-cell subsets, immunoglobulins, and soluble CD25 will be evaluated. Associations between immunologic changes and changes in FVC% predicted, DLCO% predicted, Warrick score, and KL-6 will be explored.
Time frame
Baseline, Week 12, and Week 24Sponsors and contacts
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Source ClinicalTrials.gov