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

NCT ID: NCT03139136

Last Updated: 2019-08-14

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-30

Study Completion Date

2019-08-13

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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MBS2320

Group Type ACTIVE_COMPARATOR

MBS2320

Intervention Type DRUG

As described in the arm descriptions

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

As described in the arm descriptions

Interventions

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MBS2320

As described in the arm descriptions

Intervention Type DRUG

Placebo

As described in the arm descriptions

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Modern Biosciences Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Inga Bodrug, MD

Role: PRINCIPAL_INVESTIGATOR

Arensia Exploratory Medicine

Locations

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Arensia

Tbilisi, , Georgia

Site Status

Arensia

Chisinau, , Moldova

Site Status

Arensia

Bucharest, , Romania

Site Status

Countries

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Georgia Moldova Romania

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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