Phase II Trial of low-dose Sandimmun Optoral ® (Cyclosporine A) for the treatment of primary Sjögren's syndrome (pSS) - Cypress

• Conditions: Primary Sjögren's Syndrome; MedDRA version: 12.1Level: LLTClassification code 10059142Term: Sjoegren's syndrome

• Registration Number: EUCTR2009-013976-38-DE
• Lead Sponsor: Charité Berlin, Department of rheumatology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-07
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Primary Sjögren's Syndrome according to european-american classification criteria

2. Joint involvement defined as minimum 3 painfull and/or 3 swollen joints at Screening and Baseline

3. Stable treatment including NSAID's for a minimum of 4 weeks

4. Males & females aged 18 - 75 years

5. Adequate hematologically results defined as Hb = 10 g/dl, Thrombocytes = 100.000/µl und Neutrophils = 2.500/µl

6. Serum-Creatinin-Koncentration and/ or Creatinin-Clearance in normal range

7. Female patients of childbearing potential must have a negative pregnancy-test at screening

8. Males and females of childbearing potential must use a reliable method of contraception

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Body weight < 45 kg and > 110 kg

2. Intraarticular or systemic treatment with glucocorticoids within 4 weeks before Baseline

3. Treatment with narcotic analgetics (excluding permitted concomittant medications such as Tramadol and Codein)

4. Diagnosis of other, severe, chronic-inflammatory diseases

5. Previous systemic treatment with Cyclosporine A

6. Uncontrolled hypertension

7. Significant or uncontrolled concomitant disease

8. Relevant and active infection

9. Abnormal liver function test (AP or ALT elevated = 1,5 x upper normal range)

10. Abnormal Serum-Creatinin-Koncentration and/ or Creatinin-Clearance

11. History of neoplasm except:
- curative treated Non-Malign-Skin-Cancer,
- treated cervical carcinoma in situ,
- other curative treated neoplasm without evidence of recrudescence
over 10 years

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of efficacy of low-dose Cyclosporine A in patients with primary Sjögren’s Syndrome and joint involvement after 16 week treatment period. ;Secondary Objective: Evaluation of safety of low-dose Cyclosporine A in patients with Sjögren’s Syndrome<br><br>Examination of general well being and improvement of sicca symptoms<br><br>Influence on disease activity according to ESSDAI<br><br>Evaluation of joint inflammation using ultrasound technique<br>;Primary end point(s): Evaluation of efficacy of low-dose Cyclosporine A in patients with primary Sjögren’s Syndrome and joint involvement after 16 week treatment period. <br><br>Significant improvement of number of swollen and tender joints.