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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
IPI-145-04
Universal Trial Number (UTN)
Trial acronym
ASPIRA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects who achieve a 20% improvement in the American College of Rheumatology Criteria (ACR20) from Baseline to Week 12
Timepoint [1] 0 0
Baseline (Day 1), Weeks 2, 4, 6, 8, 10 and 12

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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2015
Sample size
Target
Accrual to date
Final
322
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Pleven
Country [2] 0 0
Bulgaria
State/province [2] 0 0
Plovdiv
Country [3] 0 0
Bulgaria
State/province [3] 0 0
Ruse
Country [4] 0 0
Bulgaria
State/province [4] 0 0
Sofia
Country [5] 0 0
Bulgaria
State/province [5] 0 0
Stara Zagora
Country [6] 0 0
Bulgaria
State/province [6] 0 0
Targovishte
Country [7] 0 0
Bulgaria
State/province [7] 0 0
Varna
Country [8] 0 0
Colombia
State/province [8] 0 0
Antioquia
Country [9] 0 0
Colombia
State/province [9] 0 0
Cundinamarca
Country [10] 0 0
Colombia
State/province [10] 0 0
Santander
Country [11] 0 0
Germany
State/province [11] 0 0
Frankfurt
Country [12] 0 0
Germany
State/province [12] 0 0
Halle
Country [13] 0 0
Hungary
State/province [13] 0 0
Budapest
Country [14] 0 0
Hungary
State/province [14] 0 0
Kecskemet
Country [15] 0 0
Hungary
State/province [15] 0 0
Mezokovesd
Country [16] 0 0
Hungary
State/province [16] 0 0
Nyiregyhaza
Country [17] 0 0
Hungary
State/province [17] 0 0
Veszprem
Country [18] 0 0
Mexico
State/province [18] 0 0
Col Roam Sur
Country [19] 0 0
Mexico
State/province [19] 0 0
Del Cuautemoc
Country [20] 0 0
Mexico
State/province [20] 0 0
Guanajuato
Country [21] 0 0
Mexico
State/province [21] 0 0
Jalisco
Country [22] 0 0
Mexico
State/province [22] 0 0
Mexico DF
Country [23] 0 0
Mexico
State/province [23] 0 0
Michoacan
Country [24] 0 0
Mexico
State/province [24] 0 0
Nuevo Leon
Country [25] 0 0
Mexico
State/province [25] 0 0
San Luis Potosi, C.P.
Country [26] 0 0
Mexico
State/province [26] 0 0
Yucatan
Country [27] 0 0
Mexico
State/province [27] 0 0
Mexico City
Country [28] 0 0
New Zealand
State/province [28] 0 0
Auckland
Country [29] 0 0
New Zealand
State/province [29] 0 0
Wellington
Country [30] 0 0
Poland
State/province [30] 0 0
Mazowiecki
Country [31] 0 0
Poland
State/province [31] 0 0
Okulickiego
Country [32] 0 0
Poland
State/province [32] 0 0
Bialystok
Country [33] 0 0
Poland
State/province [33] 0 0
Elblag
Country [34] 0 0
Poland
State/province [34] 0 0
Krakow
Country [35] 0 0
Poland
State/province [35] 0 0
Lublin
Country [36] 0 0
Poland
State/province [36] 0 0
Nadarzyn
Country [37] 0 0
Poland
State/province [37] 0 0
Poznan
Country [38] 0 0
Poland
State/province [38] 0 0
Skierniewice
Country [39] 0 0
Poland
State/province [39] 0 0
Sosnowiec
Country [40] 0 0
Poland
State/province [40] 0 0
Stalowa Wola
Country [41] 0 0
Poland
State/province [41] 0 0
Starachowice
Country [42] 0 0
Poland
State/province [42] 0 0
Wroclaw
Country [43] 0 0
Romania
State/province [43] 0 0
Baia Mare
Country [44] 0 0
Romania
State/province [44] 0 0
Braila
Country [45] 0 0
Romania
State/province [45] 0 0
Bucharest
Country [46] 0 0
Romania
State/province [46] 0 0
Oradea
Country [47] 0 0
Romania
State/province [47] 0 0
Timisoara
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Karelia
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Ryazanskaya Oblast
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Moscow
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Orenburg
Country [52] 0 0
Russian Federation
State/province [52] 0 0
Saratov
Country [53] 0 0
Russian Federation
State/province [53] 0 0
St. Petersburg
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Vladimir
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Yaroslavl
Country [56] 0 0
Serbia
State/province [56] 0 0
Belgrade
Country [57] 0 0
Serbia
State/province [57] 0 0
Novi Sad
Country [58] 0 0
Ukraine
State/province [58] 0 0
Donetsk
Country [59] 0 0
Ukraine
State/province [59] 0 0
Kharkiv
Country [60] 0 0
Ukraine
State/province [60] 0 0
Kyiv
Country [61] 0 0
Ukraine
State/province [61] 0 0
Lviv
Country [62] 0 0
Ukraine
State/province [62] 0 0
Poltava
Country [63] 0 0
Ukraine
State/province [63] 0 0
Ternopil
Country [64] 0 0
Ukraine
State/province [64] 0 0
Zaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
SecuraBio
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01851707
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hagop Youssoufian, MD
Address 0 0
Verastem, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01851707