A Study to Assess the Efficacy of RO5459072 in Participants With Primary Sjogren's Syndrome
Status: | Completed |
---|---|
Conditions: | Rheumatology |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 8/3/2018 |
Start Date: | July 5, 2016 |
End Date: | July 10, 2017 |
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2A Study to Assess the Efficacy of RO5459072 in Patients With Primary Sjogren's Syndrome
This is a randomized, double-blind, placebo-controlled, two-treatment arm, parallel-group
study designed to evaluate the effects of RO5459072 treatment on disease activity and
symptoms of Sjogren's syndrome in adult participants with moderate to severe primary
Sjogren's syndrome. The total duration of the study for each participant will be
approximately 18 weeks (including screening).
study designed to evaluate the effects of RO5459072 treatment on disease activity and
symptoms of Sjogren's syndrome in adult participants with moderate to severe primary
Sjogren's syndrome. The total duration of the study for each participant will be
approximately 18 weeks (including screening).
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
We found this trial at
13
sites
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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