Rheumatoid Arthritis Clinical Trial
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
NCT number | NCT01626573 |
Other study ID # | 39110-201 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | March 2012 |
Est. completion date | October 2013 |
Verified date | March 2019 |
Source | Incyte Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 106 |
Est. completion date | October 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Incyte Corporation |
United States, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | ||
Primary | 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 | 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). | Following 15 days of therapy. |
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