Back to resultsA 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
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Itacitinib
Itacitinib Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, RA, Active
Eligibility Criteria
Inclusion Criteria:
- Subjects with active RA aged 18 to 75 years of age and meet tender and swollen joint assessment expectations defined in the study protocol.
- c-Reactive protein (CRP) or erythrocyte sedimentation rate (ESR) laboratory values meet minimal study protocol expectations.
Exclusion Criteria:
- Females who are pregnant or breastfeeding.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Itacitinib 400 mg twice a day
Itacitinib 400 mg placebo twice a day
Itacitinib 100 mg twice a day
Itacitinib 100 mg placebo twice a day
Itacitinib 100mg once a day
Itacitinib 100 mg placebo once a day
Itacitinib 200 mg twice a day
Itacitinib 200 mg placebo twice a day
Itacitinib 300 mg once a day
Itacitinib 300 mg placebo once a day
Itacitinib 600 mg once a day
Itacitinib 600 mg placebo once a day
Arm Description
Itacitinib 400 mg twice a day
Itacitinib 400 mg placebo twice a day
This dose group will be studied twice during the study.
This dose group will be studied twice during the study.
Itacitinib 100mg once a day
Itacitinib 100 mg placebo once a day
Itacitinib 200 mg twice a day
Itacitinib 200 mg placebo twice a day
Itacitinib 300 mg once a day
Itacitinib 300 mg placebo once a day
Itacitinib 600 mg once a day
Itacitinib 600 mg placebo once a day
Outcomes
Primary Outcome Measures
Safety and tolerability of itacitinib as assessed by the changes in frequency and severity of adverse events, ECGs, vital signs, physical examinations, and clinical laboratory evaluations.
Preliminary efficacy as assessed by the percentage of patients achieving ACR20 improvement from baseline on the day 28 and day 84 visits.
Secondary Outcome Measures
Preliminary Pharmacokinetic (PK) collections.
Plasma concentrations of itacitinib will be used to estimate peak plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01626573
Brief Title
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
Official Title
A Double- Blind, Placebo Controlled 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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a study evaluating a 28-day course followed by a 56-day course of itacitinib in patients with active rheumatoid arthritis (RA). The study will evaluate safety and efficacy parameters of itacitinib.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, RA, Active
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Itacitinib 400 mg twice a day
Arm Type
Experimental
Arm Description
Itacitinib 400 mg twice a day
Arm Title
Itacitinib 400 mg placebo twice a day
Arm Type
Placebo Comparator
Arm Description
Itacitinib 400 mg placebo twice a day
Arm Title
Itacitinib 100 mg twice a day
Arm Type
Experimental
Arm Description
This dose group will be studied twice during the study.
Arm Title
Itacitinib 100 mg placebo twice a day
Arm Type
Placebo Comparator
Arm Description
This dose group will be studied twice during the study.
Arm Title
Itacitinib 100mg once a day
Arm Type
Experimental
Arm Description
Itacitinib 100mg once a day
Arm Title
Itacitinib 100 mg placebo once a day
Arm Type
Placebo Comparator
Arm Description
Itacitinib 100 mg placebo once a day
Arm Title
Itacitinib 200 mg twice a day
Arm Type
Experimental
Arm Description
Itacitinib 200 mg twice a day
Arm Title
Itacitinib 200 mg placebo twice a day
Arm Type
Placebo Comparator
Arm Description
Itacitinib 200 mg placebo twice a day
Arm Title
Itacitinib 300 mg once a day
Arm Type
Experimental
Arm Description
Itacitinib 300 mg once a day
Arm Title
Itacitinib 300 mg placebo once a day
Arm Type
Placebo Comparator
Arm Description
Itacitinib 300 mg placebo once a day
Arm Title
Itacitinib 600 mg once a day
Arm Type
Experimental
Arm Description
Itacitinib 600 mg once a day
Arm Title
Itacitinib 600 mg placebo once a day
Arm Type
Placebo Comparator
Arm Description
Itacitinib 600 mg placebo once a day
Intervention Type
Drug
Intervention Name(s)
Itacitinib
Other Intervention Name(s)
INCB039110
Intervention Type
Drug
Intervention Name(s)
Itacitinib Placebo
Primary Outcome Measure Information:
Title
Safety and tolerability of itacitinib as assessed by the changes in frequency and severity of adverse events, ECGs, vital signs, physical examinations, and clinical laboratory evaluations.
Time Frame
Approximately four months.
Title
Preliminary efficacy as assessed by the percentage of patients achieving ACR20 improvement from baseline on the day 28 and day 84 visits.
Time Frame
Approximately 84 days.
Secondary Outcome Measure Information:
Title
Preliminary Pharmacokinetic (PK) collections.
Description
Plasma concentrations of itacitinib will be used to estimate peak plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC).
Time Frame
Following 15 days of therapy.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with active RA aged 18 to 75 years of age and meet tender and swollen joint assessment expectations defined in the study protocol.
c-Reactive protein (CRP) or erythrocyte sedimentation rate (ESR) laboratory values meet minimal study protocol expectations.
Exclusion Criteria:
Females who are pregnant or breastfeeding.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor Sandor, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
City
Palm Desert
State/Province
California
Country
United States
City
Pasadena
State/Province
California
Country
United States
City
Lake Mary
State/Province
Florida
Country
United States
City
Ocala
State/Province
Florida
Country
United States
City
Palm Harbor
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Tavares
State/Province
Florida
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Worcester
State/Province
Massachusetts
Country
United States
City
Lansing
State/Province
Michigan
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Middleburg Heights
State/Province
Ohio
Country
United States
City
Duncansville
State/Province
Pennsylvania
Country
United States
City
Florence
State/Province
South Carolina
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Katy
State/Province
Texas
Country
United States
City
Spokane
State/Province
Washington
Country
United States
City
Carolina
Country
Puerto Rico
12. IPD Sharing Statement
Learn more about this trial
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
We'll reach out to this number within 24 hrs