CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 309 enrolled
Drug / intervention
CNTO148 +1 moredrug
Likely dose
CNTO148 50–300 mg subcutaneously every 4 weeksAI-extracted
Key inclusion· 5
  • ✓Physician diagnosis of asthma for ≥3 years and severe persistent asthma for ≥1 year before screening
  • ✓Continuous high-dose inhaled corticosteroid and long-acting β2-agonist for ≥3 months before screening
  • ✓Evidence of reversible airway obstruction (≥12% FEV1 change post-bronchodilator) or diurnal PEFR variation (≥30% change) or airway hyperresponsiveness within 5 years or during screening
  • ✓Persistent asthma symptoms on >1/3 of days for ≥3 months despite high-dose ICS+LABA (e.g., wheezing, breathlessness, chest tightness, cough, nocturnal awakening)
Key exclusion· 5
  • ✕Diagnosis of COPD, cystic fibrosis, or other significant respiratory disorder
  • ✕Asthma worsening requiring oral corticosteroid increase or addition (steroid burst) in the 4 weeks before screening
  • ✕Life-threatening asthma attack requiring cardiopulmonary support (e.g., intubation) in the 6 months before screening
  • ✕Prior use of alkylating agents (chlorambucil or cyclophosphamide)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00207740
NCT00207740Phase 2Completed
CompareCT.gov

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 148 Administered Subcutaneously in Symptomatic Subjects With Severe Persistent Asthma

Centocor, Inc.·interventional·Posted Sep 21, 2005·Updated Aug 20, 2012

In Brief

A Phase 2 clinical trial evaluating CNTO148 and Placebo for Asthma. Completed, enrolled 309 participants across 57 sites in 11 countries.

Detailed Summary

The purpose of this study is to evaluate the effectiveness and safety of CNTO 148 (golimumab) in patients with severe persistent asthma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesBelgium, Bulgaria, Czechia, France, Germany, Hungary, Netherlands, Poland, Sweden, United Kingdom, United States
CollaboratorsCentocor BV

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 21, 2005
Enrollment StartAug 1, 2004
Primary CompletionJul 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 20.8 years ago

Interventions

CNTO148drug

Type=exact type, unit=mg, number=50, 75, 100, 150, 200 and 300, form=injection, route=subcutaneous. Every 4 weeks partciapnts will receive injections in 4 parallel treatment arms

Placebodrug

Type=exact type, unit=mg, form=injection, route=subcutaneous. Placebo will be given from from Week 0 through Week 52.