Safety, Tolerability and Efficacy of MBS2320 in Patients With Rheumatoid Arthritis
NCT ID: NCT03139136
Last Updated: 2019-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
121 participants
INTERVENTIONAL
2017-05-30
2019-08-13
Brief Summary
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Detailed Description
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The aim of the study is to evaluate the safety and tolerability of MBS2320 in patients with RA following chronic administration. In addition, the study aims to evaluate the effects of MBS2320 on measures of disease activity.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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MBS2320
MBS2320
As described in the arm descriptions
Placebo
Placebo
As described in the arm descriptions
Interventions
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MBS2320
As described in the arm descriptions
Placebo
As described in the arm descriptions
Eligibility Criteria
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Inclusion Criteria
* between 18 and 75 years of age, inclusive.
Exclusion Criteria
* Patients who are being treated with biological or non-biological disease-modifying anti-rheumatic drug therapy.
* Patients with a history of any other inflammatory or arthritic disease in addition to RA that may interfere with the study.
18 Years
75 Years
ALL
No
Sponsors
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Modern Biosciences Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Inga Bodrug, MD
Role: PRINCIPAL_INVESTIGATOR
Arensia Exploratory Medicine
Locations
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Arensia
Tbilisi, , Georgia
Arensia
Chisinau, , Moldova
Arensia
Bucharest, , Romania
Countries
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Other Identifiers
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2016-004038-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
120012A
Identifier Type: -
Identifier Source: org_study_id
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