Rheumatoid Arthritis

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

Incyte Study ID:
39110-201
CT.gov ID:
NCT01626573
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463
Study Complete
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Clinical Study Purpose

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.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Rheumatoid Arthritis
    • PRODUCT
  • Drug: Itacitinib
  • Drug: Itacitinib Placebo
    • COLLABORATORS
    N/A
    DATE
    Mar 2012 - Jul 2013
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18 - 75 Years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion 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.

    Clinical Study Locations

    Location
    Status
    Location
    Carolina, Puerto Rico, US
    Status
    Completed
    Location
    Worchester, MA, US
    Status
    Completed
    Location
    Ocala, FL, US
    Status
    Completed
    Location
    Florence, SC, US
    Status
    Completed
    Location
    Tampa, FL, US
    Status
    Completed
    Location
    Spokane, WA, US
    Status
    Completed

    Protocol Summary

    Incyte Study ID:
    39110-201
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Triple (Participant, Investigator, Outcomes Assessor)
    Interventions:
    Drug
    Enrollment:
    106
    Primary Outcome
    Open

    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.

    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 Outcome
    Open

    Preliminary Pharmacokinetic (PK) collections.

    Timeframe: Following 15 days of therapy.