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A Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT00550043
First received: October 24, 2007
Last updated: March 9, 2015
Last verified: March 2015
Results First Received: February 9, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: INCB018424
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo No text entered.
Cohort 1: Treatment Group A INCB018424 15 mg BID
Cohort 2: Treatment Group B INCB018424 5 mg BID
Cohort 2: Treatment Group C INCB018424 25 mg BID
Cohort 2: Treatment Group D INCB018424 50 mg QD

Participant Flow:   Overall Study
    Placebo     Cohort 1: Treatment Group A     Cohort 2: Treatment Group B     Cohort 2: Treatment Group C     Cohort 2: Treatment Group D  
STARTED     9     12     9     10     10  
COMPLETED     9     9     8     8     9  
NOT COMPLETED     0     3     1     2     1  
Adverse Event                 0                 0                 0                 1                 1  
Subject Withdrew Consent                 0                 2                 1                 0                 0  
Other Reasons- Unspecified                 0                 1                 0                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Placebo No text entered.
Cohort 1: Treatment Group A INCB018424 15 mg BID
Cohort 2: Treatment Group B INCB018424 5 mg BID
Cohort 2: Treatment Group C INCB018424 25 mg BID
Cohort 2: Treatment Group D INCB018424 50 mg QD
Total Total of all reporting groups

Baseline Measures
    Placebo     Cohort 1: Treatment Group A     Cohort 2: Treatment Group B     Cohort 2: Treatment Group C     Cohort 2: Treatment Group D     Total  
Number of Participants  
[units: participants]
  9     12     9     10     10     50  
Age  
[units: years]
Mean (Standard Deviation)
  55.2  (12.04)     56.9  (8.44)     49.6  (10.69)     57.5  (11.29)     54.5  (14.14)     54.9  (11.23)  
Gender  
[units: participants]
           
Female     8     8     7     7     8     38  
Male     1     4     2     3     2     12  



  Outcome Measures
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1.  Primary:   The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement   [ Time Frame: Day 28 ]

2.  Secondary:   The Percentage of Subjects Achieving ACR 50 Improvement   [ Time Frame: Day 28 ]

3.  Secondary:   The Percentage of Subjects Achieving ACR 70 Improvement   [ Time Frame: Day 28 ]

4.  Secondary:   Change From Baseline in Disease Activity Score 28 (DAS 28) ESR Score   [ Time Frame: Baseline, Day 28 ]

5.  Secondary:   Change From Baseline in Disease Activity Score 28 (DAS 28) CRP Score   [ Time Frame: Baseline, Day 28 ]

6.  Secondary:   Percentage of Subjects Who Achieved DAS 28 ESR Low Disease   [ Time Frame: Day 28 ]

7.  Secondary:   Percentage of Subjects Who Achieved DAS 28 CRP Low Disease   [ Time Frame: Day 28 ]

8.  Secondary:   Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease   [ Time Frame: Day 28 ]

9.  Secondary:   Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease   [ Time Frame: Day 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Incyte Corporation
phone: 1-855-463-3463



Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT00550043     History of Changes
Other Study ID Numbers: INCB 18424-231
Study First Received: October 24, 2007
Results First Received: February 9, 2015
Last Updated: March 9, 2015
Health Authority: United States: Food and Drug Administration
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products