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Eine Studie zur Beurteilung der Wirksamkeit von RO5459072 bei primärem Sjögren-Syndrom
A Study to Assess the Efficacy of RO5459072 in Participants With Primary Sjogren's Syndrome
- Autoimmunerkrankung
- Sjogren-Syndrom
Bitte beachten Sie, dass der Rekrutierungsstatus der Studie an Ihrem Standort vom Gesamtstatus der Studie abweichen kann, da einige Studienzentren früher rekrutieren als andere.
Status der Studie:
Abgeschlossen
Diese Studie läuft in
Stadt
- Berlin
Studien-ID:
NCT02701985 2015-004476-30 BP30037
Studienzusammenfassung
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).
Hoffmann-La Roche
Sponsor
Phase 2
Phase
NCT02701985,BP30037,2015-004476-30
Studien-ID
Placebo, RO5459072
Treatments
Sjogren's Syndrome
Condition
Official Title
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
Einschlusskriterien
All
Gender
≥ 18 Years & ≤ 75 Years
Age
No
Healthy Volunteers
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)
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