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
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
1 other identifier
interventional
106
2 countries
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 rheumatoid-arthritis
Started Mar 2012
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 3, 2012
CompletedFirst Posted
Study publicly available on registry
June 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedMarch 12, 2019
March 1, 2019
1.3 years
May 3, 2012
March 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Approximately four months.
Preliminary efficacy as assessed by the percentage of patients achieving ACR20 improvement from baseline on the day 28 and day 84 visits.
Approximately 84 days.
Secondary Outcomes (1)
Preliminary Pharmacokinetic (PK) collections.
Following 15 days of therapy.
Study Arms (12)
Itacitinib 400 mg twice a day
EXPERIMENTALItacitinib 400 mg twice a day
Itacitinib 400 mg placebo twice a day
PLACEBO COMPARATORItacitinib 400 mg placebo twice a day
Itacitinib 100 mg twice a day
EXPERIMENTALThis dose group will be studied twice during the study.
Itacitinib 100 mg placebo twice a day
PLACEBO COMPARATORThis dose group will be studied twice during the study.
Itacitinib 100mg once a day
EXPERIMENTALItacitinib 100mg once a day
Itacitinib 100 mg placebo once a day
PLACEBO COMPARATORItacitinib 100 mg placebo once a day
Itacitinib 200 mg twice a day
EXPERIMENTALItacitinib 200 mg twice a day
Itacitinib 200 mg placebo twice a day
PLACEBO COMPARATORItacitinib 200 mg placebo twice a day
Itacitinib 300 mg once a day
EXPERIMENTALItacitinib 300 mg once a day
Itacitinib 300 mg placebo once a day
PLACEBO COMPARATORItacitinib 300 mg placebo once a day
Itacitinib 600 mg once a day
EXPERIMENTALItacitinib 600 mg once a day
Itacitinib 600 mg placebo once a day
PLACEBO COMPARATORItacitinib 600 mg placebo once a day
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Unknown Facility
Palm Desert, California, United States
Unknown Facility
Pasadena, California, United States
Unknown Facility
Lake Mary, Florida, United States
Unknown Facility
Ocala, Florida, United States
Unknown Facility
Palm Harbor, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Tavares, Florida, United States
Unknown Facility
Lexington, Kentucky, United States
Unknown Facility
Worcester, Massachusetts, United States
Unknown Facility
Lansing, Michigan, United States
Unknown Facility
Raleigh, North Carolina, United States
Unknown Facility
Middleburg Heights, Ohio, United States
Unknown Facility
Duncansville, Pennsylvania, United States
Unknown Facility
Florence, South Carolina, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Katy, Texas, United States
Unknown Facility
Spokane, Washington, United States
Unknown Facility
Carolina, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Victor Sandor, MD
Incyte Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2012
First Posted
June 22, 2012
Study Start
March 1, 2012
Primary Completion
July 1, 2013
Study Completion
October 1, 2013
Last Updated
March 12, 2019
Record last verified: 2019-03