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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Itacitinib 400 mg twice a day | Experimental | Itacitinib 400 mg twice a day |
|
| Itacitinib 400 mg placebo twice a day | Placebo Comparator | Itacitinib 400 mg placebo twice a day |
|
| Itacitinib 100 mg twice a day | Experimental | This dose group will be studied twice during the study. |
|
| Itacitinib 100 mg placebo twice a day | Placebo Comparator | This dose group will be studied twice during the study. |
|
| Itacitinib 100mg once a day | Experimental | Itacitinib 100mg once a day |
|
| Itacitinib 100 mg placebo once a day | Placebo Comparator | Itacitinib 100 mg placebo once a day |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itacitinib | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victor Sandor, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palm Desert | California | United States | ||||
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|
| Itacitinib 200 mg twice a day | Experimental | Itacitinib 200 mg twice a day |
|
| Itacitinib 200 mg placebo twice a day | Placebo Comparator | Itacitinib 200 mg placebo twice a day |
|
| Itacitinib 300 mg once a day | Experimental | Itacitinib 300 mg once a day |
|
| Itacitinib 300 mg placebo once a day | Placebo Comparator | Itacitinib 300 mg placebo once a day |
|
| Itacitinib 600 mg once a day | Experimental | Itacitinib 600 mg once a day |
|
| Itacitinib 600 mg placebo once a day | Placebo Comparator | Itacitinib 600 mg placebo once a day |
|
|
| Itacitinib Placebo | Drug |
|
| Pasadena |
| California |
| United States |
| Lake Mary | Florida | United States |
| Ocala | Florida | United States |
| Palm Harbor | Florida | United States |
| Tampa | Florida | United States |
| Tavares | Florida | United States |
| Lexington | Kentucky | United States |
| Worcester | Massachusetts | United States |
| Lansing | Michigan | United States |
| Raleigh | North Carolina | United States |
| Middleburg Heights | Ohio | United States |
| Duncansville | Pennsylvania | United States |
| Florence | South Carolina | United States |
| Austin | Texas | United States |
| Katy | Texas | United States |
| Spokane | Washington | United States |
| Carolina | Puerto Rico |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C000718170 | itacitinib |
| C000603457 | INCB039110 |
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