Status:
COMPLETED
A Double-Blind Study Evaluating Duvelisib in Subjects With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone
Lead Sponsor:
SecuraBio
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate the safety and efficacy of multiple dose levels of the investigational product (study drug), IPI-145, in combination with methotrexate compared to methotrex...
Detailed Description
This Phase 2 study is designed to examine the efficacy and safety of multiple dose levels of IPI-145 in subjects with active moderate-to-severe Rheumatoid Arthritis receiving a background stable dose ...
Eligibility Criteria
Inclusion
- Documented diagnosis of Rheumatoid Arthritis for at least 6 months
- Active disease, based on Screening clinical and laboratory criteria, despite taking methotrexate for at least 3 months
Exclusion
- Pregnant or lactating females
- Previous failure or inadequate response to \>2 biologic disease-modifying anti-rheumatic drugs (DMARDs)
- Concurrent DMARD treatment other than methotrexate, sulfasalazine, chloroquine, or hydroxychloroquine
- Treatment with \> 10 mg daily prednisone (or equivalent) or more than one non-steroidal anti-inflammatory drug
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
322 Patients enrolled
Trial Details
Trial ID
NCT01851707
Start Date
April 1 2013
End Date
February 1 2015
Last Update
March 17 2021
Active Locations (64)
Enter a location and click search to find clinical trials sorted by distance.
1
Pleven, Bulgaria
2
Plovdiv, Bulgaria
3
Rousse, Bulgaria
4
Sofia, Bulgaria