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A Study of Ocrelizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA)

NCT02720120 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2016-03-28

No results posted yet for this study

Summary

This study is in two parts and will evaluate the safety, tolerability and efficacy of escalating single intravenous (IV) doses of ocrelizumab compared with placebo in combination with methotrexate in participants with moderate to severe RA. Part 1 is the dose-escalation study, at one of the following dose levels of ocrelizumab \[400, 1000, 1500, and 2000 milligrams (mg)\]. In Part 2, participants will be randomized to explore tolerability and efficacy of doses which have been shown to be tolerated in Part 1.

Conditions

Interventions

DRUG

Ocrelizumab

Participants will receive single IV infusion of ocrelizumab at 400, 1000, 1500, and 2000 mg.

DRUG

Placebo

Participants will receive single IV infusion of placebo.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

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
2005-10-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • Australia
  • Belgium
  • Canada
  • Netherlands
  • New Zealand
  • Russia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT02720120 on ClinicalTrials.gov