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A Study of Safety and Efficacy of CNTO 148 in Patients With Severe Persistent Asthma

This study has been completed.
Sponsor:
Collaborator:
Centocor BV
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00207740
First received: September 13, 2005
Last updated: August 14, 2012
Last verified: August 2012
History of Changes
Results First Received: May 21, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: CNTO148
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 309 patients were randomized into 4 parallel treatment groups at 53 sites (134 patients at 27 sites in the US and 175 patients at 26 sites in Europe). The first patient was consented on 31 Aug 2004, and the last patient completed the study on 17 Jul 2007.

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
Group I: Placebo Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
Group II: Golimumab 50 mg Golimumab (CNTO148) 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
Group III: Golimumab 100 mg Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
Group IV: Golimumab 200 mg Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52

Participant Flow:   Overall Study
    Group I: Placebo     Group II: Golimumab 50 mg     Group III: Golimumab 100 mg     Group IV: Golimumab 200 mg  
STARTED     78     77     76     78  
COMPLETED     49 [1]   36 [1]   36 [1]   35 [1]
NOT COMPLETED     29     41     40     43  
Adverse Event                 4                 14                 14                 11  
Unsatisfactory therapeutic effect                 1                 0                 2                 4  
Lost to Follow-up                 0                 2                 1                 1  
Death                 0                 0                 0                 1  
Sponsor Directive                 22                 15                 16                 21  
Not Specified                 2                 10                 7                 5  
[1] Indicates number of patients who received subcutaneous study medication through Week 52



  Baseline Characteristics
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Reporting Groups
  Description
Group I: Placebo Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
Group II: Golimumab 50 mg Golimumab (CNTO148) 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
Group III: Golimumab 100 mg Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
Group IV: Golimumab 200 mg Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
Total Total of all reporting groups

Baseline Measures
    Group I: Placebo     Group II: Golimumab 50 mg     Group III: Golimumab 100 mg     Group IV: Golimumab 200 mg     Total  
Number of Participants  
[units: participants]
 		  78     77     76     78     309  
Age  
[units: years]
Mean ± Standard Deviation 		  49.4  ± 12.03     49.4  ± 11.26     49.1  ± 12.85     52.7  ± 12.26     50.1  ± 12.14  
Gender  
[units: participants]
 		         
Female     42     46     39     46     173  
Male     36     31     37     32     136  



  Outcome Measures
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1.  Primary:   Change From Baseline in Prebronchodilator Clinic-Measured, Percent-Predicted Forced Expiratory Volume in 1 Second   [ Time Frame: Baseline and Week 24 ]
  Show Outcome Measure 1

2.  Primary:   Number of Severe Asthma Exacerbations Per Patient From Baseline Through 6 Months   [ Time Frame: Baseline to Week 24 ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in Asthma Quality of Life Questionnaire Score at 6 Months; Randomized Patients   [ Time Frame: Baseline to Week 24 ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline in Rescue Medication Use at 6 Months; Randomized Patients   [ Time Frame: Baseline to Week 24 ]
  Show Outcome Measure 4

5.  Secondary:   Number of Severe Asthma Exacerbations Per Patient From Week 24 Through Week 52; Randomized Patients Who Did Not Discontinue Study Participation Prior to Week 24   [ Time Frame: Week 24 to Week 52 ]
  Show Outcome Measure 5

6.  Secondary:   Change From Baseline in Oral Corticosteroids Dose at Week 52; Randomized Patients Who Received Oral Corticosteroids at Baseline   [ Time Frame: Baseline and Week 52 ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in Domiciliary Morning Peak Expiratory Flow Rate (PEFR) at 6 Months; Randomized Subjects   [ Time Frame: Baseline to Week 24 ]
  Show Outcome Measure 7


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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 count of patients with any nonserious adverse events (NAE) excludes patients who only had NAE that occurred in <= 5% of patients. This information may vary from existing approved labeling and publications due to the requirement of this website.  


Results Point of Contact:  
Name/Title: Director Clinical Research
Organization: Centocor Research & Development, Inc.
phone: 1-800-457-6399


No publications provided by Centocor, Inc.

Publications automatically indexed to this study:


Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00207740     History of Changes
Other Study ID Numbers: CR005281, C0524T03
Study First Received: September 13, 2005
Results First Received: May 21, 2009
Last Updated: August 14, 2012
Health Authority: United States: Food and Drug Administration