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Infliximab to Treat Crohn'S-like Inflammatory Bowel Disease in Chronic Granulomatous Disease

This study has been terminated.
(Insufficient patient participation)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT00325078
First received: May 11, 2006
Last updated: November 19, 2015
Last verified: November 2015
Results First Received: March 18, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Chronic Granulomatous Disease
Crohn'S-like IBD
Inflammatory Bowel Disease (IBD)
Intervention: Drug: Infliximab

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment Group

This group comprises patients with Chronic granulomatous disease (CGD) complicated by significant inflammatory bowel disease (IBD). The subjects are treated with a TNFa inhibitor at standard recommended doses for treatment of Crohn’s disease. Infliximab is administered as intravenous infusions at 5mg/kg on weeks 0, 2 and 6 for induction and every 6-8 weeks at 5-10mg/kg for maintenance. Adalimumab is administered at 160mg, 60mg, 40mg, 40mg on weeks 0, 2, 4 and 6 via subcutaneous injection.

Endoscopies and gastrointestinal mucosal biopsies are obtained before treatment, following induction, and again at completion of treatment.

Observation Group CGD patients with IBD who are not treated with any study medication and are monitored for rate of infections.
Control Volunteer Subjects who volunteer to participate in endoscopy and GI mucosal biopsies to provide controls for the study. The subjects in this arm may be healthy subjects, CGD subjects without GI symptoms, or subjects with Crohn’s disease (CD). The rate of infections in the CGD patients without IBD are monitored.

Participant Flow:   Overall Study
    Treatment Group     Observation Group     Control Volunteer  
STARTED     8     7     25  
COMPLETED     3     2     23  
NOT COMPLETED     5     5     2  



  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
Treatment Group

This group comprises patients with Chronic granulomatous disease (CGD) complicated by significant inflammatory bowel disease (IBD). The subjects are treated with a TNFa inhibitor at standard recommended doses for treatment of Crohn’s disease. Infliximab is administered as intravenous infusions at 5mg/kg on weeks 0, 2 and 6 for induction and every 6-8 weeks at 5-10mg/kg for maintenance. Adalimumab is administered at 160mg, 60mg, 40mg, 40mg on weeks 0, 2, 4 and 6 via subcutaneous injection.

Endoscopies and gastrointestinal mucosal biopsies are obtained before treatment, following induction, and again at completion of treatment.

Observation Group CGD patients with IBD who are not treated with any study medication and are monitored for rate of infections.
Control Volunteer Subjects who volunteer to participate in endoscopy and GI mucosal biopsies to provide controls for the study. The subjects in this arm may be healthy subjects, CGD subjects without GI symptoms, or subjects with Crohn’s disease (CD). The rate of infections in the CGD patients without IBD are monitored.
Total Total of all reporting groups

Baseline Measures
    Treatment Group     Observation Group     Control Volunteer     Total  
Number of Participants  
[units: participants]
  8     7     25     40  
Age  
[units: Participants]
       
<=18 years     1     3     0     4  
Between 18 and 65 years     7     4     25     36  
>=65 years     0     0     0     0  
Gender  
[units: Participants]
       
Female     1     0     6     7  
Male     7     7     19     33  
Ethnicity (NIH/OMB)  
[units: Participants]
       
Hispanic or Latino     0     1     2     3  
Not Hispanic or Latino     8     6     22     36  
Unknown or Not Reported     0     0     1     1  
Race (NIH/OMB)  
[units: Participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     0     0     1     1  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     0     0     6     6  
White     8     6     15     29  
More than one race     0     0     0     0  
Unknown or Not Reported     0     1     3     4  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Safety of Study Drug   [ Time Frame: Baseline to 1 year ]

2.  Primary:   Efficacy of Treatment With Study Drug   [ Time Frame: Baseline, 1 year ]

3.  Other Pre-specified:   Gut Immune Cell Types and Their Cytokine Profile   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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
Due to limited subject participation and lack of sustained clinical benefits (1 year), there is insufficient complete data to generate meaningful statistics for the outcome measures. Instead, this data are reported as a case series.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: De Ravin, SukSee
Organization: National Institute of Allergy and Infectious Diseases
phone: +1 301 496 6772
e-mail: sderavin@mail.nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT00325078     History of Changes
Other Study ID Numbers: 060160
06-I-0160
Study First Received: May 11, 2006
Results First Received: March 18, 2014
Last Updated: November 19, 2015
Health Authority: United States: Federal Government
US: NIAID NIH