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GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease (SHIELD-2)

This study has been terminated.
(This study was terminated due to the lack of efficacy of GSK1605786A in Crohn's disease based on the results of Study CCX114151.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01316939
First Posted: March 16, 2011
Last Update Posted: September 7, 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: June 28, 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
This study was conducted at 128 centers in 28 countries with sites in North America, Europe, Israel, South Africa, Japan, Republic of Korea, Hong Kong, Australia, and New Zealand from 09 May 2011 and 23 October 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study was planned to randomize approximately 756 participants (252 participants per group) from induction studies CCX114151 and CCX114643. However a total of 229 participants (159 who participated in study CCX114151 and 70 who participated in study CCX114643) were randomized and comprised the analysis population for this study.

Reporting Groups
  Description
Placebo Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 milligram (mg) capsules.
GSK1605786A 500 mg Once Daily Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
GSK1605786A 500 mg BID Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules twice daily (BID).

Participant Flow:   Overall Study
    Placebo   GSK1605786A 500 mg Once Daily   GSK1605786A 500 mg BID
STARTED   76   77   76 
COMPLETED   13   9   7 
NOT COMPLETED   63   68   69 
Study closed/terminated                26                25                23 
Lack of Efficacy                24                25                25 
Adverse Event                9                12                11 
Withdrawal by Subject                1                3                6 
Physician Decision                2                2                1 
Lost to Follow-up                0                0                2 
Met Liver chemistry stopping criteria                1                0                1 
Protocol Violation                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.
No text entered.

Reporting Groups
  Description
Placebo Eligible participants received 52 weeks randomized, double-blind treatment with oral matching placebo capsules to GSK1605786A 500 mg capsules.
GSK1605786A 500 mg Once Daily Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules once daily.
GSK1605786A 500 mg BID Eligible participants received 52 weeks randomized, double-blind treatment with oral GSK1605786A 500 mg capsules BID.
Total Total of all reporting groups

Baseline Measures
   Placebo   GSK1605786A 500 mg Once Daily   GSK1605786A 500 mg BID   Total 
Overall Participants Analyzed 
[Units: Participants]
 76   77   76   229 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.2  (13.20)   36.7  (13.00)   38.8  (12.75)   37.9  (12.96) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      46  60.5%      35  45.5%      42  55.3%      123  53.7% 
Male      30  39.5%      42  54.5%      34  44.7%      106  46.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      1   1.3%      1   0.4% 
Asian      4   5.3%      7   9.1%      6   7.9%      17   7.4% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2   2.6%      1   1.3%      0   0.0%      3   1.3% 
White      70  92.1%      67  87.0%      69  90.8%      206  90.0% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      2   2.6%      0   0.0%      2   0.9% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants in Clinical Remission (Crohn’s Disease Activity Index , CDAI Score <150 Points) at Both Weeks 28 and 52 of the 52-week Treatment Period   [ Time Frame: Week 28 and 52 ]

2.  Secondary:   Percentage of Participants in Clinical Remission (CDAI Score <150 Points) and Not Taking Corticosteroids at Both Weeks 28 and 52 of the 52-week Treatment Period   [ Time Frame: Week 28 and 52 ]

3.  Secondary:   Percentage of Participants in Clinical Remission at Both Weeks 28 and 52 of the 52-week Treatment Period Among Those Participants Who Were in Clinical Remission at Baseline   [ Time Frame: Week 28 and 52 ]

4.  Secondary:   Percentage of Participants in Clinical Remission at All Visits (Continuous Clinical Remission) During the 52-week Treatment Period Among Participants in Clinical Remission at Baseline   [ Time Frame: Upto Week 52 ]

5.  Secondary:   Percentage of Participants in Clinical Remission at Week 52   [ Time Frame: Week 52 ]

6.  Secondary:   Percentage of Participants With a Clinical Response (CDAI Decrease >=100 Points) at Both Weeks 28 and 52 of the 52-week Treatment Period   [ Time Frame: Week 28 and 52 ]

7.  Secondary:   Time to Induction of Clinical Remission in Participants Who Had Achieved Clinical Response During Induction Therapy But Were Not in Clinical Remission at Baseline   [ Time Frame: Upto Week 52 ]

8.  Secondary:   Change From Baseline in CDAI Score at Weeks 4, 8, 12, 20, 28, 36, 44, and 52   [ Time Frame: Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, and 52 ]

9.  Secondary:   Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 52   [ Time Frame: Baseline (Week 0) and Week 52 ]

10.  Secondary:   Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Upto 56 weeks ]

11.  Secondary:   Change From Baseline in Vital Sign Systolic Blood Pressure Systolic (SBP) and Diastolic Blood Pressure (DBP) Upto Week 56   [ Time Frame: Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, 52, 56 ]

12.  Secondary:   Change From Baseline in Vital Sign Heart Rate Upto Week 56   [ Time Frame: Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, 52 and 56 ]

13.  Secondary:   Number of Participants With Shift From Baseline in Hematology Parameters   [ Time Frame: Upto Week 56 ]

14.  Secondary:   Number of Participants With Shift From Baseline in Clinical Chemistry Parameters   [ Time Frame: Upto Week 56 ]

15.  Secondary:   Change From Baseline in Liver Function Test Parameter Total Bilirubin at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 and 56.   [ Time Frame: Baseline (Week 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 and 56. ]

16.  Secondary:   Change From Baseline in Liver Function Test Parameter Albumin at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56   [ Time Frame: Baseline (Week 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56 ]

17.  Secondary:   Change From Baseline in Liver Function Test Parameter Alanine Amino Transferase, Aspartate Amino Transferase, Alkaline Phosphatase and Gamma Glutamyl Transferase at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56   [ Time Frame: Baseline (Week 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56 ]

18.  Secondary:   Number of Participants With 12 Lead Electocardiogram (ECG) Abnormalities at Week 28 and 52   [ Time Frame: Week 28 and 52 ]

19.  Secondary:   Change From Baseline in Short Form – 36 Version 2 (SF-36 v2) at Weeks 28 and 52   [ Time Frame: Baseline (Week 0) and Weeks 28 and 52 ]

20.  Secondary:   Change From Baseline in European Quality of Life (EuroQol ) Five Dimensions Questionnaire (EQ-5D) at Weeks 28 and 52   [ Time Frame: Baseline (Week 0) and Weeks 28 and 52 ]

21.  Secondary:   Change From Baseline in Work Productivity & Activity Impairment – Crohn’s Disease (WPAI-CD) at Weeks 28 and 52   [ Time Frame: Baseline (Week 0) and Weeks 28 and 52 ]

22.  Secondary:   Receipt of Disability Benefits at Weeks 28 and 52   [ Time Frame: Weeks 28 and 52 ]

23.  Secondary:   Change From Baseline in Health-related Resource Utilization at Weeks 28 and 52   [ Time Frame: Baseline (Week 0) and Weeks 28 and 52 ]

24.  Secondary:   Change From Baseline in C Reactive Protein (CRP) at Weeks 28 and 52   [ Time Frame: Baseline (Week 0 and Weeks 28 and 52 ]

25.  Secondary:   Change From Baseline in Faecal Calprotectin at Weeks 28 and 52   [ Time Frame: Baseline (Week 0) and Weeks 28 and 52 ]


  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
The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn’s disease.


  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: NCT01316939     History of Changes
Other Study ID Numbers: 114157
2010-022383-12 ( EudraCT Number )
First Submitted: March 3, 2011
First Posted: March 16, 2011
Results First Submitted: June 28, 2017
Results First Posted: September 7, 2017
Last Update Posted: September 7, 2017