MedTrace Logo

An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis

NCT00207714 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2012-10-18

Study results available
· View outcomes & findings →

Summary

Multicenter, randomized, double-blind, placebo-controlled, 5-arm, dose-ranging study to assess the efficacy of subcutaneous injections of Golimumab (CNTO 148), 50 or 100 mg, at either 2- or 4- week intervals in subjects with active RA despite MTX therapy.

Conditions

Interventions

DRUG

Golimumab

Type=exact, unit=mg/ml, number= 50 to 100 , form=powder for solution for infusion, route=sub cutaneous.

DRUG

MTX

Type=exact, unit=mg/ml, number= 10, form=powder for solution for infusion, route=sub cutaneous

DRUG

Placebo

Type=exact, unit=mg/ml, form=powder for solution for infusion, route=sub cutaneous

DRUG

Infliximab

Type=exact, unit=mg/ml number= 10, form=powder for solution for infusion, route=sub cutaneous

Sponsors & Collaborators

  • Centocor BV

    collaborator INDUSTRY

  • Centocor, Inc.

    lead INDUSTRY

Principal Investigators

  • Centocor, Inc. Clinical Trial · Centocor, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-30
Primary Completion
2005-02-28
Completion
2006-02-28

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00207714 on ClinicalTrials.gov