Optimizing DMARD therapy for primary Sjogren's Syndrome - Leflunomide and Hydroxychloroquine combination therapy for patients with primary Sjogren's Syndrome

Optimizing DMARD therapy for primary Sjogren's Syndrome - Leflunomide and Hydroxychloroquine combination therapy for patients with primary Sjogren's Syndrome - LEF/HCQ combination therapy for pSS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45101

Enrollment

Registered

2017-04-19

Start date

2016-03-07

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Keratoconjunctivitis sicca Sjogren's disease

Interventions

For 24 weeks, patients will orally receive 1 capsule with LEF (20 mg) and 2 with HCQ (200 mg), once per day as compared to three capsules with placebo . For patients with a bodyweight

Combinationtherapy

Hydroxychloroquine

Leflunomide

Primary Sjogren's Syndrome

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1) Women and men, 18-75 years 2) Primary Sjogren's Syndrome diagnosed according to the American-European Consensus Criteria, revised in 2002 3) Lymphocyte focus score (local lymphocytic infiltrates) *1 in sublablial salivary gland specimen 4) ESSDAI * 5 5) Use of a reliable method of contraception 6) Signed written informed consent

Exclusion criteria

Exclusion criteria: 1) Pregnancy or the wish to conceive (also for men) during the study or within 2 years after the study 2) Breastfeeding 3) Therapy resistant hypertension 4) Maculopathy or retinitis pigmentosa 5) Secondary Sjogren*s Syndrome 6) Hepatic or renal impairment 7) Severe infection (including hepatitis B,C or HIV) 8) Malignancy other than mucosa-associated lymphoid tissue lymphoma (MALT lymphoma) 9) Significant cytopenia 10) Concomitant heart- and inflammatory bowel disease 11) Sarcoidosis 12) Usage of HCQ or LEF 11 mmol/L at screening 3. Standard safety procedures for MRI will be applied, for example patients with metal or internal medical devices within their body will be excluded;Patients that meet any of the exclusion criteria for the imaging part of the study will be excluded only from this part of the study. If that patient does meet criteria for inclusion in the main study, she can still participate to this main part.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Secondary endpoint is stimulated whole saliva output from baseline to endpoint at 24 weeks.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)