A Study Exploring the Safety, Tolerability, and Efficacy of a 28 Day Course Followed by an Additional 56 Day Course of Itacitinib in Subjects With Active Rheumatoid Arthritis
NCT ID: NCT01626573
Last Updated: 2019-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
106 participants
INTERVENTIONAL
2012-03-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Itacitinib 400 mg twice a day
Itacitinib 400 mg twice a day
Itacitinib
Itacitinib 400 mg placebo twice a day
Itacitinib 400 mg placebo twice a day
Itacitinib Placebo
Itacitinib 100 mg twice a day
This dose group will be studied twice during the study.
Itacitinib
Itacitinib 100 mg placebo twice a day
This dose group will be studied twice during the study.
Itacitinib Placebo
Itacitinib 100mg once a day
Itacitinib 100mg once a day
Itacitinib
Itacitinib 100 mg placebo once a day
Itacitinib 100 mg placebo once a day
Itacitinib Placebo
Itacitinib 200 mg twice a day
Itacitinib 200 mg twice a day
Itacitinib
Itacitinib 200 mg placebo twice a day
Itacitinib 200 mg placebo twice a day
Itacitinib Placebo
Itacitinib 300 mg once a day
Itacitinib 300 mg once a day
Itacitinib
Itacitinib 300 mg placebo once a day
Itacitinib 300 mg placebo once a day
Itacitinib Placebo
Itacitinib 600 mg once a day
Itacitinib 600 mg once a day
Itacitinib
Itacitinib 600 mg placebo once a day
Itacitinib 600 mg placebo once a day
Itacitinib Placebo
Interventions
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Itacitinib
Itacitinib Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* c-Reactive protein (CRP) or erythrocyte sedimentation rate (ESR) laboratory values meet minimal study protocol expectations.
Exclusion Criteria
* Men and women who cannot comply with requirements to avoid fathering a child or becoming pregnant, respectively.
* Subjects treated with a biologic agent within 12 weeks prior to first dose of study drug. (12 months in the case of rituximab.)
* Subjects with a history or currently suspected inflammatory disease other than RA.
* Subjects with a history of hematological disorders.
18 Years
75 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Victor Sandor, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Palm Desert, California, United States
Pasadena, California, United States
Lake Mary, Florida, United States
Ocala, Florida, United States
Palm Harbor, Florida, United States
Tampa, Florida, United States
Tavares, Florida, United States
Lexington, Kentucky, United States
Worcester, Massachusetts, United States
Lansing, Michigan, United States
Raleigh, North Carolina, United States
Middleburg Heights, Ohio, United States
Duncansville, Pennsylvania, United States
Florence, South Carolina, United States
Austin, Texas, United States
Katy, Texas, United States
Spokane, Washington, United States
Carolina, , Puerto Rico
Countries
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Other Identifiers
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39110-201
Identifier Type: -
Identifier Source: org_study_id
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