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.
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
18
sites
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