A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

June 10, 2010 updated by: Hoffmann-La Roche

A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis

This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with methotrexate (MTX). in patients with moderate to severe active rheumatoid arthritis (RA) who currently have an inadequate response to MTX. Patients wil be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/mg iv, or placebo iv, every 4 weeks; all patients will also receive methotrexate 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

623

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1015ABO
      • Buenos Aires, Argentina, 1405
      • Buenos Aires, Argentina, C1428CQG
  • Australia
      • Adelaide, Australia, 5041
      • Douglas, Australia, 4184
      • Maroochydore, Australia, 4558
      • Shenton Park, Australia, 6008
  • Austria
      • Wien, Austria, 1100
      • Wien, Austria, 1130
      • Wien, Austria, 1160
      • Wien, Austria, 1090
  • Brazil
      • Porto Alegre, Brazil, 91350-200
      • Sao Paulo, Brazil, 05651-901
  • Bulgaria
      • Sofia, Bulgaria, 1784
      • Sofia, Bulgaria, 1606
      • Varna, Bulgaria, 9010
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1L7
      • Victoria, British Columbia, Canada, V8V 3P9
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
    • Newfoundland and Labrador
      • St John's, Newfoundland and Labrador, Canada, A1B 3E1
    • Ontario
      • Burlington, Ontario, Canada, L7M 4Y1
      • Newmarket, Ontario, Canada, L3Y 3R7
      • Ottawa, Ontario, Canada, K1H 1A2
      • Toronto, Ontario, Canada, M4N 3M5
    • Quebec
      • Montreal, Quebec, Canada, H2L 1S6
      • Montreal, Quebec, Canada, H1T 4B3
      • Sainte-foy, Quebec, Canada, G1W 4R4
  • China
      • Hong Kong, China
      • Hong Kong, China, 852
  • France
      • Besancon, France, 25030
      • Creteil, France, 94010
      • Le Mans, France, 72000
      • Montpellier, France, 34295
      • Paris, France, 75014
      • Paris, France, 75010
      • Paris, France, 75012
  • Germany
      • Bad Bramstedt, Germany, 24576
      • Bad Nauheim, Germany, 61231
      • Baden-baden, Germany, 76530
      • Berlin, Germany, 14059
      • Erlangen, Germany, 91056
      • Heidelberg, Germany, 69120
      • Köln, Germany, 50924
      • Tübingen, Germany, 72076
  • Hungary
      • Budapest, Hungary, 1023
      • Debrecen, Hungary, 4004
      • Pécs, Hungary, 7632
  • Israel
      • Beer Sheva, Israel, 84101
      • Haifa, Israel, 31048
      • Haifa, Israel, 31096
      • Jerusalem, Israel, 91120
      • Petach Tikva, Israel, 49100
      • Tel Aviv, Israel, 64239
  • Italy
      • Ferrara, Italy, 44100
      • Gazzi, Italy, 98125
      • Palermo, Italy, 90127
      • Siena, Italy, 53100
      • Udine, Italy, 33100
  • Mexico
      • Chihuahua, Mexico, 31000
      • Guadalajara, Mexico, 44620
      • Guadalajara, Mexico, 44690
      • Mexico City, Mexico, 14080
      • Mexico City, Mexico, 07760
      • San Luis Potosi, Mexico, 78240
  • Singapore
      • Singapore, Singapore, 119074
      • Singapore, Singapore, 258499
  • Slovakia
      • Piestany, Slovakia, 921 01
  • Switzerland
      • Bern, Switzerland, 3010
      • Lausanne, Switzerland, 1011
      • St Gallen, Switzerland, 9007
  • Thailand
      • Bangkok, Thailand, 10400
      • Bangkok, Thailand, 10700
      • Chiang Mai, Thailand, 50200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients at least 18 years of age with moderate to severe active RA for at least 6 months;
  • inadequate response to a stable dose of MTX;
  • patients of reproductive potential must be using reliable methods of contraception.

Exclusion Criteria:

  • major surgery (including joint surgery) within 8 weeks before entering study, or planned surgery within 6 months after entering study;
  • prior treatment failure with an anti-tumor necrosis factor agent;
  • women who are pregnant or breast-feeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: tocilizumab [RoActemra/Actemra]
4mg/kg iv / month
Drug: tocilizumab [RoActemra/Actemra]
8mg/kg iv / month
Drug: Methotrexate
10-25mg/week
Experimental: 2
Drug: tocilizumab [RoActemra/Actemra]
4mg/kg iv / month
Drug: tocilizumab [RoActemra/Actemra]
8mg/kg iv / month
Drug: Methotrexate
10-25mg/week
Placebo Comparator: 3
Drug: Methotrexate
10-25mg/week
Drug: Placebo
iv / month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with ACR 20 response
Time Frame: Week 24
Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
AEs, laboratory parameters, vital signs
Time Frame: Throughout study
Throughout study
Percentage of patients ACR 50/70 responses; change from baseline in ACR core set components.
Time Frame: Week 24
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

March 25, 2005

First Submitted That Met QC Criteria

March 25, 2005

First Posted (Estimate)

March 28, 2005

Study Record Updates

Last Update Posted (Estimate)

June 11, 2010

Last Update Submitted That Met QC Criteria

June 10, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WA17822

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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