NCT00675649

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2008

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

First QC Date

May 8, 2008

Last Update Submit

April 9, 2015

Conditions

Asthma

Keywords

InjectionsSevere, persistent asthma

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is the time to first severe asthma exacerbation through Week 24.

    Week 24

Secondary Outcomes (1)

  • 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

    Week 24

Study Arms (2)

001

EXPERIMENTAL
Biological: CNTO 148 / Golimumab

002

PLACEBO COMPARATOR
Biological: placebo

Interventions

CNTO 148 / GolimumabBIOLOGICAL

100 mg sc injection every 4 weeks from week 0 to week 20

001
placeboBIOLOGICAL

placebo sc injection every 4 weeks from week 0 to week 20

002

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Interventions

golimumab

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Centocor, Inc. Clinical Trial

    Centocor, Inc.

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2008

First Posted

May 12, 2008

Study Start

May 1, 2008

Last Updated

April 10, 2015

Record last verified: 2015-04