eflunomide and Hydroxychloroquine combination therapy for primary Sjogren's Syndrome

Conditions: Sjogren's Syndrome
MedDRA version: 18.0Level: LLTClassification code 10040766Term: Sjogren's diseaseSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.0Level: LLTClassification code 10042846Term: Syndrome Sjogren'sSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
MedDRA version: 18.0Level: LLTClassification code 10040765Term: Sjogren'sSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Registration Number: EUCTR2014-003140-12-NL

Lead Sponsor: MC Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

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