A Study Exploring the Safety, Tolerability, and Efficacy of a 28 Day Course Followed by an Additional 56 Day Course of INCB039110 in Subjects With Active Rheumatoid Arthritis - Full Text View

Purpose

This is a study evaluating a 28-day course followed by a 56-day course of INCB039110 in patients with active rheumatoid arthritis (RA). The study will evaluate safety and efficacy parameters of INCB039110.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: INCB039110 Drug: INCB039110 Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 INCB039110 in Subjects With Active Rheumatoid Arthritis

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by Incyte Corporation:

Primary Outcome Measures:

Safety and tolerability of INCB039110 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. ] [ Designated as safety issue: Yes ]
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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Preliminary Pharmacokinetic (PK) collections. [ Time Frame: Following 15 days of therapy. ] [ Designated as safety issue: No ]
Plasma concentrations of INCB039110 will be used to estimate peak plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC).

Estimated Enrollment:	95
Study Start Date:	March 2012
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: INCB039110 400 mg twice a day	Drug: INCB039110
Placebo Comparator: INCB039110 400 mg placebo twice a day	Drug: INCB039110 Placebo
Experimental: INCB039110 100 mg twice a day This dose group will be studied twice during the study.	Drug: INCB039110
Placebo Comparator: INCB039110 100 mg placebo twice a day This dose group will be studied twice during the study.	Drug: INCB039110 Placebo
Experimental: INCB039110 100mg once a day	Drug: INCB039110
Placebo Comparator: INCB039110 100 mg placebo once a day	Drug: INCB039110 Placebo
Experimental: INCB039110 200 mg twice a day	Drug: INCB039110
Placebo Comparator: INCB039110 200 mg placebo twice a day	Drug: INCB039110 Placebo
Experimental: INCB039110 300 mg once a day	Drug: INCB039110
Placebo Comparator: INCB039110 300 mg placebo once a day	Drug: INCB039110 Placebo
Experimental: INCB039110 600 mg once a day	Drug: INCB039110
Placebo Comparator: INCB039110 600 mg placebo once a day	Drug: INCB039110 Placebo

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626573

Contacts

Contact: Incyte Corporation Call Center

1.855.463.3463

Locations

United States, California
	Recruiting
Palm Desert, California, United States
	Recruiting
Pasadena, California, United States
United States, Florida
	Recruiting
Lake Mary, Florida, United States
	Recruiting
Ocala, Florida, United States
	Recruiting
Palm Harbor, Florida, United States
	Recruiting
Tampa, Florida, United States
	Recruiting
Tavares, Florida, United States
United States, Kentucky
	Recruiting
Lexington, Kentucky, United States
United States, Massachusetts
	Recruiting
Worchester, Massachusetts, United States
United States, Michigan
	Recruiting
Lansing, Michigan, United States
United States, North Carolina
	Not yet recruiting
Raleigh, North Carolina, United States
United States, Ohio
	Not yet recruiting
Middleburg Heights, Ohio, United States
United States, Pennsylvania
	Not yet recruiting
Duncansville, Pennsylvania, United States
United States, South Carolina
	Recruiting
Florence, South Carolina, United States
United States, Texas
	Recruiting
Austin, Texas, United States
United States, Washington
	Recruiting
Spokane, Washington, United States
Puerto Rico
	Recruiting
Carolina, Puerto Rico

Sponsors and Collaborators

Incyte Corporation

Investigators

Study Director:

Monica Luchi, MD

Incyte Corporation

More Information

No publications provided

Responsible Party:	Incyte Corporation
ClinicalTrials.gov Identifier:	NCT01626573 History of Changes
Other Study ID Numbers:	39110-201
Study First Received:	May 3, 2012
Last Updated:	March 15, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Incyte Corporation:

Rheumatoid Arthritis
RA
Active

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases

Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013