Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
A diagnosis of primary Sjogren's syndrome according to the revised American-European Consensus Group (AECG) criteria
ESSDAI score greater than or equal to (\>/=) 5
ESSPRI score \>/=5
Elevated serum titers of anti-Sjogren's-syndrome-related antigen A (anti-SSA) and/or anti-Sjogren's-syndrome-related antigen B (anti-SSB) antibodies at screening
Negative pregnancy test at screening and baseline (for women only)
Willing to comply with the study procedures and restrictions, including measures to prevent pregnancy and restrictions on sperm donation
You may not be if
A diagnosis of secondary Sjogren's syndrome according to the revised AECG criteria
Severe complications of Sjogren's syndrome
Systemic immunosuppressant therapy, cyclophosphamide, or B-cell depleting therapy within 6 months prior to the screening visit
Corticosteroid therapy exceeding 7.5 mg prednisone equivalents per day
A positive test result for hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV), or tuberculosis, or any other active viral, fungal, yeast or bacterial infection at screening
A history suggesting reduced immune function or any other conditions predisposing participants to serious infection
A history of lymphoma, myeloma or monoclonal gammopathy of unknown significance (MGUS), or any other malignancies within the past 5 years
A diagnosis of fibromyalgia or significant depression
Having any concomitant disease or condition that could interfere with the conduct of the study, or that would pose an unacceptable risk to the individual
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
Women who are lactating, breastfeeding or planning to nurse
Using other prohibited medication (moderate or potent inhibitors of CYP3A4; strong inducers of CYP3A4; strong inhibitors of the transporter P-glycoprotein \[P-gp\]; sensitive substrates of CYP3A4 with a narrow therapeutic index)
Clareo Health | A Study to Assess the Efficacy of RO5459072 in Participants With Primary Sjogren's Syndrome
