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

Phase 3

Completed

• Conditions: Keratoconjunctivitis sicca; Sjogren's disease; 10003816

• Registration Number: NL-OMON45101
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

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

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 <6 months year prior to inclusion
13) Usage of immunosuppressive drugs, with the exception of a stable dose of non- steroidal inflammatory drugs (NSAID's) and a stable, low dose (*7.5 mg) of oral corticosteroids
14) Inadequate mastery of the Dutch language;Exclusion criteria for imaging part (MRI and PET/CT)
1. A history of allergy/hypersensitivity to radio-isotopes or gadolinium-containing contrast agents
2. A fasting blood glucose level of >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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is ESSDAI scores from baseline to endpoint at 24 weeks. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoint is stimulated whole saliva output from baseline to endpoint<br /><br>at 24 weeks.</p><br>