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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01626573
Recruitment Status : Completed
First Posted : June 22, 2012
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Itacitinib Drug: Itacitinib Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : March 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Itacitinib 400 mg twice a day
Itacitinib 400 mg twice a day
Drug: Itacitinib
Other Name: INCB039110

Placebo Comparator: Itacitinib 400 mg placebo twice a day
Itacitinib 400 mg placebo twice a day
Drug: Itacitinib Placebo
Experimental: Itacitinib 100 mg twice a day
This dose group will be studied twice during the study.
Drug: Itacitinib
Other Name: INCB039110

Placebo Comparator: Itacitinib 100 mg placebo twice a day
This dose group will be studied twice during the study.
Drug: Itacitinib Placebo
Experimental: Itacitinib 100mg once a day
Itacitinib 100mg once a day
Drug: Itacitinib
Other Name: INCB039110

Placebo Comparator: Itacitinib 100 mg placebo once a day
Itacitinib 100 mg placebo once a day
Drug: Itacitinib Placebo
Experimental: Itacitinib 200 mg twice a day
Itacitinib 200 mg twice a day
Drug: Itacitinib
Other Name: INCB039110

Placebo Comparator: Itacitinib 200 mg placebo twice a day
Itacitinib 200 mg placebo twice a day
Drug: Itacitinib Placebo
Experimental: Itacitinib 300 mg once a day
Itacitinib 300 mg once a day
Drug: Itacitinib
Other Name: INCB039110

Placebo Comparator: Itacitinib 300 mg placebo once a day
Itacitinib 300 mg placebo once a day
Drug: Itacitinib Placebo
Experimental: Itacitinib 600 mg once a day
Itacitinib 600 mg once a day
Drug: Itacitinib
Other Name: INCB039110

Placebo Comparator: Itacitinib 600 mg placebo once a day
Itacitinib 600 mg placebo once a day
Drug: Itacitinib Placebo



Primary Outcome Measures :
  1. 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. [ Time Frame: Approximately four months. ]
  2. Preliminary efficacy as assessed by the percentage of patients achieving ACR20 improvement from baseline on the day 28 and day 84 visits. [ Time Frame: Approximately 84 days. ]

Secondary Outcome Measures :
  1. Preliminary Pharmacokinetic (PK) collections. [ Time Frame: Following 15 days of therapy. ]
    Plasma concentrations of itacitinib will be used to estimate peak plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01626573


Locations
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United States, California
Palm Desert, California, United States
Pasadena, California, United States
United States, Florida
Lake Mary, Florida, United States
Ocala, Florida, United States
Palm Harbor, Florida, United States
Tampa, Florida, United States
Tavares, Florida, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Massachusetts
Worcester, Massachusetts, United States
United States, Michigan
Lansing, Michigan, United States
United States, North Carolina
Raleigh, North Carolina, United States
United States, Ohio
Middleburg Heights, Ohio, United States
United States, Pennsylvania
Duncansville, Pennsylvania, United States
United States, South Carolina
Florence, South Carolina, United States
United States, Texas
Austin, Texas, United States
Katy, Texas, United States
United States, Washington
Spokane, Washington, United States
Puerto Rico
Carolina, Puerto Rico
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Victor Sandor, MD Incyte Corporation
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT01626573    
Other Study ID Numbers: 39110-201
First Posted: June 22, 2012    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Keywords provided by Incyte Corporation:
Rheumatoid Arthritis
RA
Active
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases