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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01851707
Registration number
NCT01851707
Ethics application status
Date submitted
8/05/2013
Date registered
10/05/2013
Date last updated
17/03/2021
Titles & IDs
Public title
A Double-Blind Study Evaluating Duvelisib in Subjects With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone
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Scientific 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
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Secondary ID [1]
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IPI-145-04
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Universal Trial Number (UTN)
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Trial acronym
ASPIRA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - IPI-145
Treatment: Drugs - Placebo
Experimental: IPI-145, low dose BID -
Experimental: IPI-145, medium dose BID -
Experimental: IPI-145, high dose BID -
Placebo Comparator: Placebo BID -
Treatment: Drugs: IPI-145
2 blinded capsules will be administered twice a day (morning and night) for 12 weeks.
Treatment: Drugs: Placebo
2 blinded capsules will be administered twice a day (morning and night) for 12 weeks.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of subjects who achieve a 20% improvement in the American College of Rheumatology Criteria (ACR20) from Baseline to Week 12
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Assessment method [1]
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Timepoint [1]
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Baseline (Day 1), Weeks 2, 4, 6, 8, 10 and 12
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2015
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Sample size
Target
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Accrual to date
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Final
322
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Recruitment in Australia
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Recruitment outside Australia
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Bulgaria
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Pleven
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Bulgaria
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Plovdiv
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Bulgaria
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Ruse
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Bulgaria
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Halle
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Zaporizhzhya
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
SecuraBio
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01851707
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Hagop Youssoufian, MD
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Address
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Verastem, Inc.
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01851707
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