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

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT01626573

Run by

Incyte Corporation

People needed

106

Starts

2012-03-01

Expected to finish

2013-10-01

Last updated by the study team

2019-03-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Study site — Palm Desert, California, United States
• Study site — Pasadena, California, United States
• Study site — Lake Mary, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Palm Harbor, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Tavares, Florida, United States
• Study site — Lexington, Kentucky, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Lansing, Michigan, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Middleburg Heights, Ohio, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Florence, South Carolina, United States
• Study site — Austin, Texas, United States
• Study site — Katy, Texas, United States
• Study site — Spokane, Washington, United States
• Study site — Carolina, Puerto Rico

Full record on ClinicalTrials.gov

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