A Double-Blind Study Evaluating Duvelisib in Subjects With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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 methotrexate alone in subjects with active moderate-to-severe Rheumatoid Arthritis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Infinity Pharmaceuticals, Inc.; SecuraBio
• Treatments: Methotrexate

Criteria

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