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

Part of paid clinical trials in Palm Desert, California.

Sponsor
Incyte Corporation
Study ID
NCT01626573
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 31, 2012
Status verified
Mar 2019
Primary completion
Jul 31, 2013
Completion
Oct 31, 2013

Study Design

Enrollment
106 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Itacitinib 400 mg twice a day
    Itacitinib 400 mg twice a day
  • Placebo Comparator: Itacitinib 400 mg placebo twice a day
    Itacitinib 400 mg placebo twice a day
  • Experimental: Itacitinib 100 mg twice a day
    This dose group will be studied twice during the study.
  • Placebo Comparator: Itacitinib 100 mg placebo twice a day
    This dose group will be studied twice during the study.
  • Experimental: Itacitinib 100mg once a day
    Itacitinib 100mg once a day
  • Placebo Comparator: Itacitinib 100 mg placebo once a day
    Itacitinib 100 mg placebo once a day
  • Experimental: Itacitinib 200 mg twice a day
    Itacitinib 200 mg twice a day
  • Placebo Comparator: Itacitinib 200 mg placebo twice a day
    Itacitinib 200 mg placebo twice a day
  • Experimental: Itacitinib 300 mg once a day
    Itacitinib 300 mg once a day
  • Placebo Comparator: Itacitinib 300 mg placebo once a day
    Itacitinib 300 mg placebo once a day
  • Experimental: Itacitinib 600 mg once a day
    Itacitinib 600 mg once a day
  • Placebo Comparator: Itacitinib 600 mg placebo once a day
    Itacitinib 600 mg placebo once a day

Primary Outcome 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. [ Time Frame: Approximately four months. ]

Locations (17)

FacilityCityStateZIPSite coordinators
-Palm DesertCalifornia--
-PasadenaCalifornia--
-Lake MaryFlorida--
-OcalaFlorida--
-Palm HarborFlorida--
-TampaFlorida--
-TavaresFlorida--
-LexingtonKentucky--
-WorcesterMassachusetts--
-LansingMichigan--
-RaleighNorth Carolina--
-Middleburg HeightsOhio--
-DuncansvillePennsylvania--
-FlorenceSouth Carolina--
-AustinTexas--
-KatyTexas--
-SpokaneWashington--

Find similar trials in Palm Desert, CA

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders

Related Studies