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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004038-24 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBS2320 | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBS2320 | Drug | As described in the arm descriptions |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (safety and tolerability) | Incidence of all grade adverse events | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Activity Score 28 (DAS28) | Disease Activity Score according to the EULAR response criteria | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Inga Bodrug, MD | Arensia Exploratory Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arensia | Tbilisi | Georgia | ||||
| Arensia |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Drug |
As described in the arm descriptions |
|
| Chisinau |
| Moldova |
| Arensia | Bucharest | Romania |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |