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

NCT01851707 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 322

Last updated 2021-03-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

IPI-145

2 blinded capsules will be administered twice a day (morning and night) for 12 weeks.

DRUG

Placebo

2 blinded capsules will be administered twice a day (morning and night) for 12 weeks.

Sponsors & Collaborators

  • SecuraBio

    lead INDUSTRY

Principal Investigators

  • Hagop Youssoufian, MD · Verastem, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-12-31
Completion
2015-02-28

Countries

  • Bulgaria
  • Colombia
  • Germany
  • Hungary
  • Mexico
  • New Zealand
  • Poland
  • Romania
  • Russia
  • Serbia
  • Ukraine

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01851707 on ClinicalTrials.gov