Safety, Tolerability and Efficacy of MBS2320 in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03139136
• Other study ID #: 120012A
• Secondary ID: 2016-004038-24
• Status: Completed
• Phase: Phase 2
• Start date: May 30, 2017
• Est. completion date: August 13, 2019

Study information

• Verified date: August 2019
• Source: Modern Biosciences plc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: August 13, 2019
• Est. primary completion date: November 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• MBS2320
As described in the arm descriptions
• Placebo
As described in the arm descriptions

Locations

Country	Name	City	State
Georgia	Arensia	Tbilisi
Moldova, Republic of	Arensia	Chisinau
Romania	Arensia	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
Modern Biosciences plc

Countries where clinical trial is conducted

Georgia,  Moldova, Republic of,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (safety and tolerability)	Incidence of all grade adverse events	12 weeks
Secondary	Disease Activity Score 28 (DAS28)	Disease Activity Score according to the EULAR response criteria	12 weeks