|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03139136 |
|
Date of registration:
|
26/04/2017 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Safety, Tolerability and Efficacy of MBS2320 in Patients With Rheumatoid Arthritis
|
|
Scientific 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 |
|
Date of first enrolment:
|
May 30, 2017 |
|
Target sample size:
|
121 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03139136 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Georgia
|
Moldova, Republic of
|
Romania
| | | | | |
|
Contacts
|
|
Name:
|
Inga Bodrug, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Arensia Exploratory Medicine |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Rheumatoid Arthritis
|
|
Intervention(s)
|
|
Drug: MBS2320
|
|
Drug: Placebo
|
|
Primary Outcome(s)
|
|
Incidence of treatment-emergent adverse events (safety and tolerability)
[Time Frame: 12 weeks]
|
|
Secondary Outcome(s)
|
|
Disease Activity Score 28 (DAS28)
[Time Frame: 12 weeks]
|
|
Secondary ID(s)
|
|
120012A
|
|
2016-004038-24
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|