Rheumatoid Arthritis Clinical Trial
— ASPIRAOfficial title:
A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate Multiple Dose Levels of Duvelisib With Background Methotrexate in Subjects With Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone
NCT number | NCT01851707 |
Other study ID # | IPI-145-04 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | April 2013 |
Est. completion date | February 2015 |
Verified date | March 2021 |
Source | SecuraBio |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 methotrexate alone in subjects with active moderate-to-severe Rheumatoid Arthritis.
Status | Completed |
Enrollment | 322 |
Est. completion date | February 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
SecuraBio |
Bulgaria, Colombia, Germany, Hungary, Mexico, New Zealand, Poland, Romania, Russian Federation, Serbia, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of subjects who achieve a 20% improvement in the American College of Rheumatology Criteria (ACR20) from Baseline to Week 12 | Baseline (Day 1), Weeks 2, 4, 6, 8, 10 and 12 |
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