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Dose Optimisation Study of ART621 in Subjects Diagnosed With Rheumatoid Arthritis Taking Methotrexate

NCT00854685 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2010-01-06

No results posted yet for this study

Summary

The purpose of this clinical trial is to establish what dose level and dosing frequency is optimal in the treatment of rheumatoid arthritis patients with ART621.

Conditions

Interventions

DRUG

ART621

3.0mg/kg s.c. - weekly

DRUG

ART621

3.0mg/kg s.c. - fortnightly

DRUG

ART621

1.5mg/kg s.c. - weekly

DRUG

ART621

1.5mg/kg s.c. - fortnightly

DRUG

Placebo

Placebo s.c. - weekly

DRUG

Placebo

Placebo s.c. - fortnightly

Sponsors & Collaborators

  • Trident Clinical Research Pty Ltd

    collaborator INDUSTRY

  • Arana Therapeutics Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-12-31
Completion
2010-01-31

Countries

  • Sri Lanka

Study Locations

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 NCT00854685 on ClinicalTrials.gov