Leflunomide and Hydroxychloroquine combination therapy for primary Sjögren’s Syndrome

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22318

Enrollment

Registered

2020-06-29

Start date

2020-11-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Sjögren’s Syndrome

Interventions

Intervention: For 24 weeks, patients will receive 1 capsule with LEF (20 mg) and 2 capsules with HCQ (2x 200 mg) orally once per day as compared to 1 capsule with LEF-placebo and 2 capsules with HCQ-p

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women and men, aged 18-75 years 2. pSS diagnosed according to the ACR-EULAR 2016 Criteria for pSS 3. ESSDAI =5 4. Use of a reliable method of contraception 5. Signed written informed consent

Exclusion criteria

Exclusion criteria: 1. Since LEF has teratogenic effects patients who are pregnant or who are wishing to conceive (also men with a female partner of childbearing age) during or within two years after the study are excluded. During the screenings visit, pregnancy will be excluded in all female patients of childbearing age. 2. Patients that breastfeed 3. Patients with therapy resistant hypertension are excluded since this might be aggravated by LEF 4. In case of maculopathy or retinitis pigmentosa the patient will be excluded from participation. Examination by an ophtalmologist will take place on indication. 5. Patients with secondary Sjögren’s Syndrome (Sjögren’s syndrome associated with other connective tissue disease) 6. Patients with hepatic or renal impairment 7. Patients with a severe infection (including hepatitis B,C or HIV) 8. Presence of a malignancy other than mucosa-associated lymphoid tissue lymphoma (MALT lymphoma) 9. Significant cytopenia 10. Concomitant heart- and inflammatory bowel disease 11. Patients suffering from sarcoidosis 12. Usage of HCQ or LEF <6 months prior to inclusion 13. Usage of immunosuppressive drugs, with the exception of a stable dose of non- steroidal inflammatory drugs and a stable, low dose (=7.5 mg) of oral corticosteroids 14. Inadequate mastery of the Dutch language

Design outcomes

Primary

Measure	Time frame
Primary endpoint is change in ESSDAI scores from baseline to endpoint at 24 weeks.	—

Secondary

Measure	Time frame
The secondary endpoint includes changes in unstimulated/stimulated whole saliva output, ESSPRI (European SS patient reported index), ocular dryness and serological and blood inflammatory features at 24 weeks interval.	—

Contacts

Public ContactSafae Hamkour

UMC Utrecht

s.hamkour-3@umcutrecht.nlxxxxx

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)