|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
29 March 2021 |
|
Main ID: |
NCT01851707 |
|
Date of registration:
|
08/05/2013 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A Double-Blind Study Evaluating Duvelisib in Subjects With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone
ASPIRA |
|
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 |
|
Date of first enrolment:
|
April 2013 |
|
Target sample size:
|
322 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01851707 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Bulgaria
|
Colombia
|
Germany
|
Hungary
|
Mexico
|
New Zealand
|
Poland
|
Romania
|
|
Russian Federation
|
Serbia
|
Ukraine
| | | | | |
|
Contacts
|
|
Name:
|
Hagop Youssoufian, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Verastem, Inc. |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Rheumatoid Arthritis
|
|
Intervention(s)
|
|
Drug: IPI-145
|
|
Drug: Placebo
|
|
Primary Outcome(s)
|
|
Proportion of subjects who achieve a 20% improvement in the American College of Rheumatology Criteria (ACR20) from Baseline to Week 12
[Time Frame: Baseline (Day 1), Weeks 2, 4, 6, 8, 10 and 12]
|
|
Secondary ID(s)
|
|
IPI-145-04
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|