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

November 1, 2016 updated by: Hoffmann-La Roche

A Randomized, Double-blind Study of the Effect of Tocilizumab on Reduction in Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to DMARD Therapy

This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to current DMARD therapy. Patients will be randomized to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. 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)

1220

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, C1428DQG
      • Rosario, Argentina, S2000PBJ
  • Australia
      • Parkville, Australia, 3052
      • Sydney, Australia, 2050
  • Brazil
      • Campinas, Brazil, 13060-803
      • Goiania, Brazil, 74653-050
      • Rio de Janeiro, Brazil, 20551-030
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
    • Ontario
      • Hamilton, Ontario, Canada, L8N 2B6
      • Ottawa, Ontario, Canada, K1H 1A2
    • Quebec
      • Quebec City, Quebec, Canada, G1V 3M7
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
  • China
      • Beijing, China, 100044
      • Beijing, China, 100032
      • Shanghai, China, 200127
      • Shanghai, China, 200433
  • Costa Rica
      • San Jose, Costa Rica, 10103
  • Czech Republic
      • Hradec Kralove, Czech Republic, 500 05
      • Praha, Czech Republic, 128 50
      • Praha, Czech Republic, 140 59
  • Finland
      • Helsinki, Finland, 00280
      • Jyväskylä, Finland, 40620
  • France
      • Boulogne-billancourt, France, 92104
      • Clermont-ferrand, France, 63003
      • Grenoble, France, 38042
      • Limoges, France, 87042
      • Marseille, France, 13285
      • Montpellier, France, 34295
      • Nantes, France, 44035
      • Paris, France, 75181
      • Pierre Benite, France, 69495
      • Rennes, France, 35203
      • Saint-etienne, France, 4200
      • Tours, France, 37044
  • Germany
      • Aachen, Germany, 52064
      • Essen, Germany, 45239
      • Hildesheim, Germany, 31134
      • München, Germany, 80335
      • Osnabrück, Germany, 49074
      • Sendenhorst, Germany, 48324
      • Stuttgart, Germany, 70469
  • Hong Kong
      • Hong Kong, Hong Kong, 852
      • Tuen Mun, Hong Kong, 852
  • Mexico
      • Leon, Mexico, 37000
      • Mexico City, Mexico, 07760
      • Mexico City, Mexico, 14050
      • Tijuana, Mexico, 22320
  • Panama
      • Panama City, Panama, 32400
  • Russian Federation
      • Moscow, Russian Federation, 115522
      • Moscow, Russian Federation, 105203
      • Moscow, Russian Federation, 117049
      • Ryazan, Russian Federation, 390026
      • St Petersburg, Russian Federation, 190068
      • St Petersburg, Russian Federation, 191015
      • Tula, Russian Federation, 300053
  • South Africa
      • Durban, South Africa, 4001
      • Pretoria, South Africa, 0002
      • Radiokop, South Africa, 2040
  • Spain
      • Barakaldo, Spain, 48903
      • Madrid, Spain, 28040
      • Madrid, Spain, 28046
      • Malaga, Spain, 29010
      • Pontevedra, Spain, 36001
      • Santiago de Compostela, Spain, 15706
  • Sweden
      • Stockholm, Sweden, 171 76
      • Umea, Sweden, 90185
  • Thailand
      • Bangkok, Thailand, 10400
      • Bangkok, Thailand, 10330
      • Chiang Mai, Thailand, 50200
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85208
      • Paradise Valley, Arizona, United States, 85253
      • Peoria, Arizona, United States, 85381
      • Scottsdale, Arizona, United States, 85258
      • Tucson, Arizona, United States, 85723
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • Los Angeles, California, United States, 90048
      • Palm Desert, California, United States, 92260
      • Palo Alto, California, United States, 94304
      • San Jose, California, United States, 95126
      • Upland, California, United States, 91786
    • Delaware
      • Newark, Delaware, United States, 19713
    • District of Columbia
      • Washington, District of Columbia, United States, 20006
    • Florida
      • Delray Beach, Florida, United States, 33484
      • Jupiter, Florida, United States, 33458
      • Palm Habor, Florida, United States, 34684
      • Palm Harbor, Florida, United States, 34684
      • Tampa, Florida, United States, 33609
    • Illinois
      • Chicago, Illinois, United States, 60637
      • Chicago, Illinois, United States, 60611
      • Springfield, Illinois, United States, 62704
      • Vernon Hills, Illinois, United States, 60061
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Kentucky
      • Bowling Green, Kentucky, United States, 42102
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
      • Shreverport, Louisiana, United States, 71103
    • Maryland
      • Frederick, Maryland, United States, 21702
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
    • Michigan
      • Lansing, Michigan, United States, 48910
    • Minnesota
      • Duluth, Minnesota, United States, 55805
      • Eagan, Minnesota, United States, 55121
      • St. Louis Park, Minnesota, United States, 55426
    • Missouri
      • Saint Louis, Missouri, United States, 63117
      • Springfield, Missouri, United States, 65807
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
    • Nevada
      • Reno, Nevada, United States, 89502
    • New Jersey
      • Clifton, New Jersey, United States, 07012
      • Haddon Heights, New Jersey, United States, 08035
      • New Brunswick, New Jersey, United States, 08903
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
    • New York
      • New York, New York, United States, 10021
      • Plainview, New York, United States, 11803
      • Roslyn, New York, United States, 11576
      • Smithtown, New York, United States, 11787
      • Syracuse, New York, United States, 13210
    • North Carolina
      • Durham, North Carolina, United States, 27704
      • Raleigh, North Carolina, United States, 27609
      • Winston Salem, North Carolina, United States, 27157
    • Ohio
      • Beachwood, Ohio, United States, 44122
      • Cincinnati, Ohio, United States, 45219
      • Dayton, Ohio, United States, 45408
      • Gallipolis, Ohio, United States, 45631
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
      • Oklahoma City, Oklahoma, United States, 73103
      • Tulsa, Oklahoma, United States, 74104
    • Oregon
      • Medford, Oregon, United States, 97504
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
      • Bethlehem, Pennsylvania, United States, 18015
      • Philadelphia, Pennsylvania, United States, 19152
      • Pittsburgh, Pennsylvania, United States, 15261
      • Rockledge, Pennsylvania, United States, 19046
      • Willow Grove, Pennsylvania, United States, 19090
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
    • South Carolina
      • Charleston, South Carolina, United States, 29406
    • Tennessee
      • Hixson, Tennessee, United States, 37343
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Austin, Texas, United States, 78705
      • Houston, Texas, United States, 77074
      • Mesquite, Texas, United States, 75150
    • Vermont
      • Burlington, Vermont, United States, 05401
    • Virginia
      • Arlington, Virginia, United States, 22204
    • Washington
      • Spokane, Washington, United States, 99204
      • Tacoma, Washington, United States, 98405
      • Vancouver, Washington, United States, 98664
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
      • Milwaukee, Wisconsin, United States, 53226

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:

  • patients at least 18 years of age with moderate to severe active RA for at least 6 months;
  • inadequate response to current anti-rheumatic therapies, including 1 or more traditional DMARDs;
  • stable DMARD therapy for at least 8 weeks before entering study;
  • 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;
  • patients who have previously failed treatment 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]
8mg/kg iv every 4 weeks
Placebo Comparator: 2
Drug: Placebo
iv every 4 weeks

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 with ACR 50 and ACR 70 responses.
Time Frame: Week 24
Week 24
Mean changes in parameters of ACR core set
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 Start

April 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 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)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WA18063

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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