Clinical trial NCT01626573: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
RA
Active
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2012-06-22
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: Approximately four months.
measure: Preliminary efficacy as assessed by the percentage of patients achieving ACR20 improvement from baseline on the day 28 and day 84 visits.
timeFrame: Approximately 84 days.
Secondary outcomes:
measure: Preliminary Pharmacokinetic (PK) collections.
timeFrame: Following 15 days of therapy.
Other outcomes:
Locations:
city: Palm Desert
country: United States
state: California
city: Pasadena
country: United States
state: California
city: Lake Mary
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Palm Harbor
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Tavares
country: United States
state: Florida
city: Lexington
country: United States
state: Kentucky
city: Worcester
country: United States
state: Massachusetts
city: Lansing
country: United States
state: Michigan
city: Raleigh
country: United States
state: North Carolina
city: Middleburg Heights
country: United States
state: Ohio
city: Duncansville
country: United States
state: Pennsylvania
city: Florence
country: United States
state: South Carolina
city: Austin
country: United States
state: Texas
city: Katy
country: United States
state: Texas
city: Spokane
country: United States
state: Washington
city: Carolina
country: Puerto Rico
Study officials:
affiliation: Incyte Corporation
name: Victor Sandor, MD
role: STUDY_DIRECTOR
References: