A Study to Evaluate the Efficacy of RO5459072 in Participants With Primary Sjögren’s Syndrome
- Conditions
- Primary Sjögren’s syndromeMedDRA version: 20.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2015-004476-30-FR
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 70
-Males and females 18 to 75 years of age
-Primary Sjögren's syndrome diagnosed previously according to the revised American-European Consensus Group (AECG) criteria
-European League against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) score >= 5
-EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) score >= 5
-Elevated serum titres at screening of anti-Sjögren's-syndrome-related antigen A (anti-SSA) and/or anti-SSB antibodies at screening
-Negative pregnancy test at screening and baseline, and agreement to comply with measures to prevent pregnancy and restrictions on sperm donation
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
-A diagnosis of secondary Sjögren's syndrome according to the revised AECG criteria
-Severe complications of Sjögren's syndrome, such as vasculitis with renal, neurologic or cardiac involvement; interstitial lung disease and severe myositis
-Systemic immunosuppressant therapy, cyclophosphamide or B cell depleting therapy within 6 months prior to the screening visit. Low dose methotrexate treatment is, however, permitted
-Corticosteroid therapy exceeding 7.5 milligram (mg) prednisone equivalents per day
-Mechanically stimulated whole salivary flow rate at baseline of < 0.1 millilitre/minute (mL/min)
-A positive test result for hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV), a history of tuberculosis, or any other active viral, fungal, yeast or bacterial infection at the screening visit
-A history of recurring or chronic infections, any other indication of reduced immune function, or any other underlying conditions which may predispose participants to serious infection
-A history of lymphoma, myeloma (monoclonal hypergammaglobulinemia) or monoclonal gammopathy of unknown significance (MGUS), or any other malignancies within the past 5 years (except basal cell or squamous cell carcinoma of the skin that has been cured)
-A diagnosis of fibromyalgia, or a diagnosis of significant depression or anxiety that would confound the interpretation of the study results
-Severe renal impairment, moderate or severe hepatic impairment or other clinically significant hepatic disease
-Any other concomitant disease or condition or any clinically significant finding that could interfere with the conduct of the study, or pose an unacceptable risk to the individual in this study
-Participation in an investigational drug or device study within 3 months prior to screening
-Inability to comply with the study protocol for any other reason
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: 1.To investigate the effects of RO5459072 treatment on quality of life measures, auto-antibody concentrations, and pharmacodynamic measures of exocrine gland function<br>2.To collect samples for population modelling of RO5459072 pharmacokinetics<br>3.To investigate the safety and tolerability of RO5459072 treatment<br>;Main Objective: 1.To investigate the effects of RO5459072 treatment on disease activity and symptoms of primary Sjögren’s syndrome;Primary end point(s): 1.Proportion of participants showing a clinically relevant decrease in the ESSDAI score from baseline after 12 weeks;Timepoint(s) of evaluation of this end point: 1.Week 12
- Secondary Outcome Measures
Name Time Method