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A Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease (SHIELD-1)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01277666
First Posted: January 17, 2011
Last Update Posted: September 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: July 5, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Crohn's Disease
Interventions: Drug: GSK1605786A
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
A total of 608 participants with moderately-to-severely active Crohn’s disease were enrolled in this study. The study was conducted at 162 centres in 23 countries, with sites in North America, Europe, Israel, South Africa, Japan, Australia, Korea and New Zealand. Study duration was from 20 December 2010 to 11 July 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the total 1205 participants screened, 597 were screen failures and 608 participants were randomized in the study.

Reporting Groups
  Description
Placebo Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period
GSK1605786A 500 mg Once Daily Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 milligram (mg) once daily hard gelatin capsules orally for 12 weeks treatment period
GSK1605786A 500 mg Twice Daily Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period

Participant Flow:   Overall Study
    Placebo   GSK1605786A 500 mg Once Daily   GSK1605786A 500 mg Twice Daily
STARTED   203   203   202 
COMPLETED   158   144   153 
NOT COMPLETED   45   59   49 
Adverse Event                26                25                20 
Lack of Efficacy                8                20                12 
Protocol Violation                2                3                2 
Protocol Defined Stopping criteria                1                2                6 
Lost to Follow-up                1                1                2 
Withdrawal by Subject                7                8                6 
Death                0                0                1 



  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.
No text entered.

Reporting Groups
  Description
Placebo Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period.
GSK1605786A 500 mg Once Daily Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg once daily hard gelatin capsules orally for 12 weeks treatment period.
GSK1605786A 500 mg Twice Daily Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period.
Total Total of all reporting groups

Baseline Measures
   Placebo   GSK1605786A 500 mg Once Daily   GSK1605786A 500 mg Twice Daily   Total 
Overall Participants Analyzed 
[Units: Participants]
 203   203   202   608 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.1  (12.62)   37.0  (12.60)   35.9  (12.51)   36.3  (12.56) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      103  50.7%      130  64.0%      106  52.5%      339  55.8% 
Male      100  49.3%      73  36.0%      96  47.5%      269  44.2% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      1   0.5%      1   0.5%      1   0.5%      3   0.5% 
Asian      18   8.9%      21  10.3%      17   8.4%      56   9.2% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      7   3.4%      4   2.0%      2   1.0%      13   2.1% 
White      177  87.2%      177  87.2%      179  88.6%      533  87.7% 
More than one race      0   0.0%      0   0.0%      1   0.5%      1   0.2% 
Unknown or Not Reported      0   0.0%      0   0.0%      2   1.0%      2   0.3% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Crohn’s Disease Activity Index (CDAI) Response at Week 12   [ Time Frame: Week 12 ]

2.  Secondary:   Percentage of Participants With CDAI Remission at Week 12   [ Time Frame: Week 12 ]

3.  Secondary:   Percentage of Participants With a Clinical Response (CDAI Decrease From Baseline of >= 100 Points) at Both Week 8 and Week 12   [ Time Frame: At Week 8 and 12 ]

4.  Secondary:   Percentage of Participants Achieving Clinical Remission (CDAI <150 Points) at Both Week 8 and Week 12   [ Time Frame: Week 8 and 12 ]

5.  Secondary:   Percentage of Participants With a Clinical Response (CDAI Decrease From Baseline of >=100 Points) at Week 8   [ Time Frame: Week 8 ]

6.  Secondary:   Percentage of Participant Achieving Clinical Remission (CDAI <150 Points) at Week 8   [ Time Frame: Week 8 ]

7.  Secondary:   Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Both Weeks 8 and 12   [ Time Frame: Baseline (Week 0), Week 8 and Week 12 ]

8.  Secondary:   Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)   [ Time Frame: Up to Week 12 ]


  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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01277666     History of Changes
Other Study ID Numbers: 114151
First Submitted: January 13, 2011
First Posted: January 17, 2011
Results First Submitted: July 5, 2017
Results First Posted: September 19, 2017
Last Update Posted: September 19, 2017