Back to resultsSafety, Tolerability and Efficacy of MBS2320 in Patients With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MBS2320
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Male or female patients of childbearing or non-childbearing potential with with active RA, receiving stable once-weekly methotrexate
- between 18 and 75 years of age, inclusive.
Exclusion Criteria:
- Patients who are currently pregnant or breastfeeding.
- 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.
Sites / Locations
- Arensia
- Arensia
- Arensia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
MBS2320
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Incidence of treatment-emergent adverse events (safety and tolerability)
Incidence of all grade adverse events
Secondary Outcome Measures
Disease Activity Score 28 (DAS28)
Disease Activity Score according to the EULAR response criteria
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03139136
Brief Title
Safety, Tolerability and Efficacy of MBS2320 in Patients With Rheumatoid Arthritis
Official Title
A 12-Week, Double-Blind, Placebo-Controlled, Phase 2a Study to Investigate the Safety, Tolerability and Efficacy of MBS2320 in Patients With Active Rheumatoid Arthritis Receiving Methotrexate
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 30, 2017 (Actual)
Primary Completion Date
November 16, 2018 (Actual)
Study Completion Date
August 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Modern Biosciences Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent of patients don't respond to current treatments. MBS2320, the drug being tested in this trial, represents a new approach to treating RA, with the potential not only to reduce levels of inflammation but to also directly prevent bone damage.The aim of this project is to test the safety, tolerability and efficacy of MBS2320 in patients with RA in combination with an existing treatment, methotrexate.
Detailed Description
Rheumatoid Arthritis is a chronic autoimmune disease characterised by synovial inflammation and cartilage and bone degradation, leading to joint destruction and progressive disability.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MBS2320
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MBS2320
Intervention Description
As described in the arm descriptions
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
As described in the arm descriptions
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (safety and tolerability)
Description
Incidence of all grade adverse events
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Disease Activity Score 28 (DAS28)
Description
Disease Activity Score according to the EULAR response criteria
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients of childbearing or non-childbearing potential with with active RA, receiving stable once-weekly methotrexate
between 18 and 75 years of age, inclusive.
Exclusion Criteria:
Patients who are currently pregnant or breastfeeding.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inga Bodrug, MD
Organizational Affiliation
Arensia Exploratory Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arensia
City
Tbilisi
Country
Georgia
Facility Name
Arensia
City
Chisinau
Country
Moldova, Republic of
Facility Name
Arensia
City
Bucharest
Country
Romania
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety, Tolerability and Efficacy of MBS2320 in Patients With Rheumatoid Arthritis
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