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

Status:	Completed
Conditions:	Arthritis, Rheumatoid Arthritis
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	18 - 75
Updated:	3/14/2019
Start Date:	March 2012
End Date:	October 2013

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

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.

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.

We found this trial at

sites

Clinical Trial Facility in Tampa Florida

Tampa, Florida

1117

from

Tampa, FL