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Safety, Efficacy and Pharmacokinetics Study of ALD518 in Patients With Active Rheumatoid Arthritis

NCT00867516 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2020-07-09

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and efficacy of ALD518 in three different doses in patients who have not had an adequate response to methotrexate.

Conditions

  • Arthritis, Rheumatoid

Interventions

BIOLOGICAL

ALD518

Two doses of ALD518, each given in an infusion of normal saline, IV over 1 hour, at Weeks 1 and 8

BIOLOGICAL

Infusion without ALD518'

250 cc Normal saline IV over one hour Weeks 1 and 8.

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Jeffrey Smith, MD, FRCP · Alder BioPharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-06-30
Completion
2009-12-31

Countries

  • Canada
  • Georgia
  • India
  • Poland
  • Russia
  • Serbia

Study Locations

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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 NCT00867516 on ClinicalTrials.gov