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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 6 October 2015
Main ID:  EUCTR2014-003140-12-NL
Date of registration: 26/08/2015
Prospective Registration: Yes
Primary sponsor: UMC Utrecht
Public title: Leflunomide and Hydroxychloroquine combination therapy for primary Sjogren's Syndrome
Scientific title: 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
Date of first enrolment: 21/09/2015
Target sample size:
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003140-12
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2  
Phase: 
Countries of recruitment
Netherlands
Contacts
Name: A.A. Kruize   
Address:  Heidelberglaan 100 3584 CX Utrecht Netherlands
Telephone: +31887557358
Email: a.kruize@umcutrecht.nl
Affiliation:  UMC Utrecht
Name: A.A. Kruize   
Address:  Heidelberglaan 100 3584 CX Utrecht Netherlands
Telephone: +31887557358
Email: a.kruize@umcutrecht.nl
Affiliation:  UMC Utrecht
Key inclusion & exclusion 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:
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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: no
Health Condition(s) or Problem(s) studied
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 tissue disorders
MedDRA version: 18.0 Level: LLT Classification code 10040765 Term: Sjogren's System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

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
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: Plaquenil
Product Name: Plaquenil
Pharmaceutical Form: Capsule
INN or Proposed INN: HYDROXYCHLOROQUINE
CAS Number: 118-42-3
Concentration unit: Bq/mg becquerel(s)/milligram
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: Reduction in disease activity, measured by ESSDAI (EULAR Sjogren's syndrome disease activity index)
Primary end point(s): Improvement of disease activity measured by ESSDAI
Secondary Objective: Improvement of dryness measured by stimulated whole saliva output
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 Outcome(s)
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
Secondary ID(s)
LEF-HCQinpSS
Source(s) of Monetary Support
ZonMw
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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