Status:
WITHDRAWN
A Clinical Trial Evaluating the Safety and Effectiveness of Golimumab in Patients With Severe, Persistent Asthma
Lead Sponsor:
Centocor, Inc.
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the safety and effects (good and bad) of golimumab therapy in patients with severe, persistent asthma.
Detailed Description
Golimumab is a type of tumor necrosis factor (TNF) inhibitor. TNF is a naturally occurring substance in the body and this substance may cause long-term inflammation. Golimumab may help treat this dise...
Eligibility Criteria
Inclusion
- Physician diagnosis of asthma for \>= 3 years and a diagnosis of severe, persistent asthma for \>= 1 year prior to screening
- Reversible airway obstruction
- Continuous treatment with high dose inhaled corticosteroids and long-acting Beta2-agonist for at least 3 months prior to screening
- At least 1 occasion in the previous 6 months when worsening of asthma required treatment with additional steroids (intravenous or oral)
- Score of \>= 2 points on the Asthma Control Questionnaire (ACQ) at screening
Exclusion
- Diagnosis of chronic obstructive pulmonary disease (COPD), cystic fibrosis, or other significant respiratory disorder
- Life-threatening asthma attack requiring intubation in the 6-month period prior to screening
- Steroid use at a dose \> 20 mg of prednisone at the screening visit
- Known malignancy or history of malignancy
- Previous exposure to anti-TNF therapies
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00675649
Start Date
May 1 2008
Last Update
April 10 2015
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.