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

NCT00928317 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2010-01-06

No results posted yet for this study

Summary

The purpose of this clinical trial is to assess the safety, efficacy, tolerability, immunogenicity and pharmacokinetics of 3 dose levels of ART621 in the treatment of rheumatoid arthritis.

Conditions

Interventions

DRUG

ART621

3.0mg/kg s.c.

DRUG

ART621

1.5mg/kg s.c.

DRUG

ART621

0.75mg/kg s.c.

DRUG

Placebo

Placebo s.c.

Sponsors & Collaborators

  • Arana Therapeutics Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-11-30
Completion
2009-12-31

Countries

  • United States
  • Argentina
  • Australia
  • Czechia
  • India
  • Malaysia
  • New Zealand
  • Poland

Study Locations

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Entities

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 NCT00928317 on ClinicalTrials.gov