Leflunomide and Hydroxychloroquine combination therapy for primary Sjogren's Syndrome

• 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
• 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

Countries of recruitment

Netherlands

Contacts

• Name: A.A. Kruize
• Affiliation: UMC Utrecht

• Name: A.A. Kruize
• 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

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

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

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)

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 Objective: Improvement of dryness measured by stimulated whole saliva output

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 Outcome(s)

Timepoint(s) of evaluation of this end point: After 24 weeks of treatment with either LEF and HCQ, or placebo

Secondary end point(s): Dryness measured by stimulated whole saliva

Secondary ID(s)

LEF-HCQinpSS

Source(s) of Monetary Support

ZonMw