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Leflunomide and Hydroxychloroquine combination therapy for 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 in pSS

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-003140-12-NL
Enrollment
Unknown
Registered
2015-08-26
Start date
2015-09-21
Completion date
Unknown
Last updated
2015-10-06

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

Conditions

Sjogren's Syndrome MedDRA version: 18.0 Level: LLT Classification code 10040766 Term: Sjogren's disease System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0 Level: PT Classification code 10040767 Term: Sjogren's syndrome System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0 Level: LLT Classification code 10042846 Term: Syndrome Sjogren's System Organ Class: 10028395 - Musculoskeletal and connective ti

Interventions

Trade Name: Leflunomide Mylan Product Name: Leflunomide mylan Pharmaceutical Form: Capsule INN or Proposed INN: LEFLUNOMIDE CAS Number: 75706-12-6 Concentration unit: Bq/mg becquerel(s)/milligram Conc

Sponsors

UMC Utrecht
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) women, age 18-75 years 2) pSS 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) presence of autoantibodies directed to pSS-related SSA and/or SSB nuclear antigens 6) use of a reliable method of contraception 7) signed written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: 1) Pregnancy or the wish to conceive during the study or within 2 years after the study 2) Breastfeeding 3) Therapy-resistent 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 cardiac- and inflammatory bowel disease 11) Sarcoidosis 12) Usage of LEF of HCQ <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

MeasureTime frame
Main Objective: Reduction in disease activity, measured by ESSDAI (EULAR Sjogren's syndrome disease activity index);Secondary Objective: Improvement of dryness measured by stimulated whole saliva output;Primary end point(s): Improvement of disease activity measured by ESSDAI ;Timepoint(s) of evaluation of this end point: After 24 weeks of treatment with either LEF and HCQ, or placebo-LEF and placebo-HCQ—

Secondary

MeasureTime frame
Secondary end point(s): Dryness measured by stimulated whole saliva;Timepoint(s) of evaluation of this end point: After 24 weeks of treatment with either LEF and HCQ, or placebo—

Countries

Netherlands

Contacts

Public ContactA.A. Kruize

UMC Utrecht

a.kruize@umcutrecht.nl+31887557358

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026