NCT03139136

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started May 2017

Typical duration for phase_2 rheumatoid-arthritis

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

May 30, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2019

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

1.5 years

First QC Date

April 26, 2017

Last Update Submit

August 13, 2019

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Incidence of treatment-emergent adverse events (safety and tolerability)

    Incidence of all grade adverse events

    12 weeks

Secondary Outcomes (1)

  • Disease Activity Score 28 (DAS28)

    12 weeks

Study Arms (2)

MBS2320

ACTIVE COMPARATOR
Drug: MBS2320

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MBS2320DRUG

As described in the arm descriptions

MBS2320
PlaceboDRUG

As described in the arm descriptions

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Arensia

Tbilisi, Georgia

Location

Arensia

Chisinau, Moldova

Location

Arensia

Bucharest, Romania

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Inga Bodrug, MD

    Arensia Exploratory Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2017

First Posted

May 3, 2017

Study Start

May 30, 2017

Primary Completion

November 16, 2018

Study Completion

August 13, 2019

Last Updated

August 14, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

MO(1)GE(1)RO(1)