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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT01626573
First received: May 3, 2012
Last updated: February 10, 2014
Last verified: February 2014

May 3, 2012
February 10, 2014
March 2012
July 2013   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 two months. ] [ Designated as safety issue: Yes ]
  • Preliminary efficacy as assessed by the percentage of patients achieving ACR20 improvement from baseline on the day 28 visit. [ Time Frame: Approximately 28 days. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01626573 on ClinicalTrials.gov Archive Site
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).
Same as current
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: INCB039110
  • Drug: INCB039110 Placebo
  • Experimental: INCB039110 400 mg twice a day
    INCB039110 400 mg twice a day
    Intervention: Drug: INCB039110
  • Placebo Comparator: INCB039110 400 mg placebo twice a day
    INCB039110 400 mg placebo twice a day
    Intervention: Drug: INCB039110 Placebo
  • Experimental: INCB039110 100 mg twice a day
    This dose group will be studied twice during the study.
    Intervention: Drug: INCB039110
  • Placebo Comparator: INCB039110 100 mg placebo twice a day
    This dose group will be studied twice during the study.
    Intervention: Drug: INCB039110 Placebo
  • Experimental: INCB039110 100mg once a day
    INCB039110 100mg once a day
    Intervention: Drug: INCB039110
  • Placebo Comparator: INCB039110 100 mg placebo once a day
    Intervention: Drug: INCB039110 Placebo
  • Experimental: INCB039110 200 mg twice a day
    Intervention: Drug: INCB039110
  • Placebo Comparator: INCB039110 200 mg placebo twice a day
    Intervention: Drug: INCB039110 Placebo
  • Experimental: INCB039110 300 mg once a day
    Intervention: Drug: INCB039110
  • Placebo Comparator: INCB039110 300 mg placebo once a day
    Intervention: Drug: INCB039110 Placebo
  • Experimental: INCB039110 600 mg once a day
    Intervention: Drug: INCB039110
  • Placebo Comparator: INCB039110 600 mg placebo once a day
    Intervention: Drug: INCB039110 Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
October 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01626573
39110-201
No
Incyte Corporation
Incyte Corporation
Not Provided
Study Director: Victor Sandor, MD Incyte Corporation
Incyte Corporation
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP