Leflunomide and Hydroxychloroquine combination therapy for primary Sjögren’s Syndrome; RepurpSS-II study

Conditions

primary Sjögren's Syndrome

Brief summary

The change in ESSDAI upon treatment with LEF/HCQ in pSS patients from baseline to 24 weeks, as compared to treatment with placebo-LEF and placebo-HCQ.

Detailed description

The change upon treatment with LEF/HCQ in pSS patients from baseline upto 24 weeks, as compared to placebo, in the change in dryness as measured by unstimulated whole unstimulated and stimulated saliva output in pSS patients., The change upon treatment with LEF/HCQ in pSS patients from baseline upto 24 weeks, as compared to placebo, in EULAR Sjögren’s Syndrome Patient Reported Index or ESSPRI (disease activity from patient’s perspective), The change upon treatment with LEF/HCQ in pSS patients from baseline upto 24 weeks, as compared to placebo, in Lachrymal flow measured by Shirmer’s test, Ocular Staining Score and Tear breakup time., The change upon treatment with LEF/HCQ in pSS patients from baseline upto 24 weeks, as compared to placebo, in the change in tender joint count and swollen joint count (68/66).

Related papers

No related papers found yet.

Interventions

DRUGLeflunomide CF 20 mg

DRUGfilmomhulde tabletten

DRUGHydorxychloroquine 200mg/Placebo

DRUGHydroxychloroquinesulfaat 200 mg Focus

DRUGHydroxychloroquinesulfaat CF 200 mg

DRUGLeflunomide Mylan 10 mg

DRUGLeflunomide 20mg/Placebo

DRUGLeflunomide Mylan 20 mg

DRUGPlaquenil 200 mg

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The change in ESSDAI upon treatment with LEF/HCQ in pSS patients from baseline to 24 weeks, as compared to treatment with placebo-LEF and placebo-HCQ.	—

Secondary

Measure	Time frame
The change upon treatment with LEF/HCQ in pSS patients from baseline upto 24 weeks, as compared to placebo, in the change in dryness as measured by unstimulated whole unstimulated and stimulated saliva output in pSS patients., The change upon treatment with LEF/HCQ in pSS patients from baseline upto 24 weeks, as compared to placebo, in EULAR Sjögren’s Syndrome Patient Reported Index or ESSPRI (disease activity from patient’s perspective), The change upon treatment with LEF/HCQ in pSS patients from baseline upto 24 weeks, as compared to placebo, in Lachrymal flow measured by Shirmer’s test, Ocular Staining Score and Tear breakup time., The change upon treatment with LEF/HCQ in pSS patients from baseline upto 24 weeks, as compared to placebo, in the change in tender joint count and swollen joint count (68/66).	—

Measure

Time frame

The change upon treatment with LEF/HCQ in pSS patients from baseline upto 24 weeks, as compared to placebo, in the change in dryness as measured by unstimulated whole unstimulated and stimulated saliva output in pSS patients., The change upon treatment with LEF/HCQ in pSS patients from baseline upto 24 weeks, as compared to placebo, in EULAR Sjögren’s Syndrome Patient Reported Index or ESSPRI (disease activity from patient’s perspective), The change upon treatment with LEF/HCQ in pSS patients from baseline upto 24 weeks, as compared to placebo, in Lachrymal flow measured by Shirmer’s test, Ocular Staining Score and Tear breakup time., The change upon treatment with LEF/HCQ in pSS patients from baseline upto 24 weeks, as compared to placebo, in the change in tender joint count and swollen joint count (68/66).

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Countries

Netherlands

Outcome results

None listed