A Double-Blind Study Evaluating Duvelisib in Subjects With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone
ASPIRA
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
1 other identifier
interventional
322
11 countries
64
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 methotrexate alone in subjects with active moderate-to-severe Rheumatoid Arthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 rheumatoid-arthritis
Started Apr 2013
Typical duration for phase_2 rheumatoid-arthritis
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 8, 2013
CompletedFirst Posted
Study publicly available on registry
May 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedMarch 17, 2021
March 1, 2021
1.7 years
May 8, 2013
March 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
IPI-145, low dose BID
EXPERIMENTALIPI-145, medium dose BID
EXPERIMENTALIPI-145, high dose BID
EXPERIMENTALPlacebo BID
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SecuraBiolead
Study Sites (64)
Unknown Facility
Pleven, Bulgaria
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Plovdiv, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Targovishte, Bulgaria
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Varna, Bulgaria
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Medellín, Antioquia, Colombia
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Bogota, Cundinamarca, Colombia
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Bucaramanga, Santander Department, Colombia
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Frankfurt, Germany
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Halle, Germany
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Budapest, Hungary
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Kecskemét, Hungary
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Mezőkövesd, Hungary
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Nyíregyháza, Hungary
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Veszprém, Hungary
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Mexico City, Col Roam Sur, Mexico
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Mexico City, Del Cuautemoc, Mexico
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León, Guanajuato, Mexico
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Guadalajara, Jalisco, Mexico
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Madero, Mexico DF, Mexico
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Morelia, Michoacán, Mexico
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Monterrey, Nuevo León, Mexico
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San Luis Potosí City, San Luis Potosi, C.P., Mexico
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Mérida, Yucatán, Mexico
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Mexico City, Mexico
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Otahuhu, Auckland, New Zealand
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Wellington, New Zealand
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Grodzisk, Mazowiecki, Poland
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Krakow, Okulickiego, Poland
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Bialystok, Poland
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Elblag, Poland
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Krakow, Poland
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Lublin, Poland
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Nadarzyn, Poland
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Poznan, Poland
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Skierniewice, Poland
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Sosnowiec, Poland
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Stalowa Wola, Poland
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Starachowice, Poland
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Wroclaw, Poland
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Baia Mare, Romania
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Brăila, Romania
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Bucharest, Romania
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Oradea, Romania
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Timișoara, Romania
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Petrozavodsk, Republic of Karelia, Russia
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Ryazan, Ryazan Oblast, Russia
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Moscow, Russia
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Orenburg, Russia
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Saint Petersburg, Russia
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Saratov, Russia
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Vladimir, Russia
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Yaroslavl, Russia
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Belgrade, Serbia
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Novi Sad, Serbia
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Donetsk, Ukraine
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Kharkiv, Ukraine
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Kyiv, Ukraine
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Lviv, Ukraine
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Poltava, Ukraine
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Ternopil, Ukraine
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Zaporizhzhya, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hagop Youssoufian, MD
Verastem, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2013
First Posted
May 10, 2013
Study Start
April 1, 2013
Primary Completion
December 1, 2014
Study Completion
February 1, 2015
Last Updated
March 17, 2021
Record last verified: 2021-03