A Clinical Trial Evaluating the Safety and Effectiveness of Golimumab in Patients With Severe, Persistent Asthma - Full Text View

Sponsored by:	Centocor, Inc.
Information provided by:	Centocor, Inc.
ClinicalTrials.gov Identifier:	NCT00675649

Purpose

The purpose of this study is to assess the safety and effects (good and bad) of golimumab therapy in patients with severe, persistent asthma.

Condition	Intervention	Phase
Asthma	Biological: CNTO 148 / Golimumab Biological: placebo	Phase II

MedlinePlus related topics: Asthma

Drug Information available for: Golimumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo Controlled Parallel-Group Study Evaluating the Efficacy and Safety of Golimumab Administered Subcutaneously in Symptomatic Subjects With Severe, Persistent Asthma

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:

The primary endpoint is the time to first severe asthma exacerbation through Week 24. [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Secondary endpoints include the number of severe asthma exacerbations through Week 24, number of clinically significant asthma exacerbations through Week 24, and change from baseline in Asthma Quality of Life Questionnaire (AQLQ) overall score at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Estimated Study Completion Date:	October 2010

Arms	Assigned Interventions
001: Experimental	Biological: CNTO 148 / Golimumab 100 mg sc injection every 4 weeks from week 0 to week 20
002: Placebo Comparator	Biological: placebo placebo sc injection every 4 weeks from week 0 to week 20

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 disease by blocking the activity of TNF in the body and reducing the symptoms of severe, persistent asthma.This study will assess the safety and effectiveness of subcutaneously (under the skin) administered golimumab and determine if there is a reduction of signs and symptoms in patients with active severe, persistent asthma. The effect of subcutaneously (SC) administered golimumab on the quality of life in patients with severe, persistent asthma will also be assessed. About 200 patients will take part in the study at approximately 60 centers worldwide. Participation in the study will last for about 42 weeks. The study consists of 3 phases: the screening phase (lasting between 1 and 4 weeks), the treatment phase (20 weeks), and the follow-up phase (20 weeks). Visits are scheduled to occur once every 4 weeks during the treatment and follow-up phases of the study. Patients eligible to take part in this study will be randomly placed into one of the following study groups: Group 1: Placebo (an inactive or dummy treatment that looks the same as the study drug, golimumab, but does not contain any active medication) from Week 0 through Week 20. Group 2: Golimumab 100 mg from Week 0 through Week 20. This study is "blinded." This means that neither patient nor study doctor will know in which group a patient is placed. However, if needed for safety or health reasons, the study doctor can find out a patient's study group at any time.

Patients will receive an injection (under the skin) of placebo (Group 1) or golimumab 100 mg (Group 2) every 4 weeks from Week 0 through Week 20.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675649

Sponsors and Collaborators

Centocor, Inc.

Investigators

Study Director:

Centocor, Inc. Clinical Trial

Centocor, Inc.

More Information

Responsible Party:	Centocor, Inc. ( Director of Clinical Research )
Study ID Numbers:	CR014980, C0524T26, EudraCT No.: 2007-005699-15
Study First Received:	May 8, 2008
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00675649
Health Authority:	United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:

Injections
Severe, persistent asthma

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 16, 2009