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

November 1, 2016 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 Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy

This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate 10-25mg/week. 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)

499

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

  • Australia
      • Malvern, Australia, 3144
      • Shenton Park, Australia, 6008
      • Sydney, Australia, 2050
      • Woolloongabba, Australia, 4102
  • Belgium
      • Aalst, Belgium, 9300
      • Hasselt, Belgium, 3500
      • Merksem, Belgium, 2170
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2V 1P9
      • Edmonton, Alberta, Canada, T5H 3V9
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
    • Ontario
      • Burlington, Ontario, Canada, L7M 4Y1
      • Kitchener, Ontario, Canada, N2M 5N6
      • London, Ontario, Canada, N6A 4V2
      • Mississauga, Ontario, Canada, L5M 2V8
      • Newmarket, Ontario, Canada, L3Y 3R7
      • Toronto, Ontario, Canada, M5T 3L9
    • Quebec
      • Montreal, Quebec, Canada, H2L 1S6
  • France
      • Amiens, France, 80054
      • Bordeaux, France, 33076
      • Le Kremlin Bicetre, France, 94275
      • Lille, France, 59037
      • Lyon, France, 69437
      • Nice, France, 06202
      • Paris, France, 75475
      • Paris, France, 75679
      • Strasbourg, France, 67098
      • Toulouse, France, 31054
  • Germany
      • Berlin, Germany, 10117
      • Dresden, Germany, 01067
      • Gommern, Germany, 39245
      • Herne, Germany, 44652
      • Köln, Germany, 50924
      • München, Germany, 81541
      • Wiesbaden, Germany, 65191
      • Wuerzburg, Germany, 97080
  • Iceland
      • Reykjavik, Iceland, 108
  • Italy
      • Brescia, Italy, 25123
      • Milano, Italy, 20122
      • Milano, Italy, 20157
      • Padova, Italy, 35128
      • Pavia, Italy, 27100
      • Pisa, Italy, 56100
      • Udine, Italy, 33100
  • Mexico
      • Guadalajara, Mexico, 44620
  • Netherlands
      • Enschede, Netherlands, 7511 JX
      • Nijmegen, Netherlands, 6525 GA
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
  • Sweden
      • Jonkoping, Sweden, 551 85
      • Karlstad, Sweden, 65185
      • Malmo, Sweden, 205 02
      • Stockholm, Sweden, 171 76
  • Switzerland
      • Lausanne, Switzerland, 1011
  • United Kingdom
      • Basingstoke, United Kingdom, RG24 9NA
      • Bath, United Kingdom, BA1 1RL
      • Birmingham, United Kingdom, B29 6JD
      • Cannock, United Kingdom, WS11 5XY
      • Derby, United Kingdom, DE22 3NE
      • Lancaster, United Kingdom, LA1 4RP
      • Leeds, United Kingdom, LS1 3EX
      • Liverpool, United Kingdom, L9 7AL
      • London, United Kingdom, SE1 9RT
      • London, United Kingdom, SE5 9PJ
      • Manchester, United Kingdom, M13 9WL
      • Manchester, United Kingdom, M41 5SL
      • Middlesborough, United Kingdom, TS4 3BW
      • Newcastle Upon Tyne, United Kingdom, NE1 4LP
      • Norwich, United Kingdom, NR4 7UY
      • Oxford, United Kingdom, OX3 7LD
      • Salford, United Kingdom, M6 8HD
      • Southampton, United Kingdom, SO16 6YD
      • Stoke-on-trent, United Kingdom, ST6 7AG
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
      • Huntsville, Alabama, United States, 35801
    • Arizona
      • Scottsdale, Arizona, United States, 85258
      • Scottsdale, Arizona, United States, 85251
      • Tucson, Arizona, United States, 85724
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
      • Little Rock, Arkansas, United States, 72205
    • California
      • Anaheim, California, United States, 92801
      • Fullerton, California, United States, 92835
      • Long Beach, California, United States, 90806
      • Long Beach, California, United States, 90808
      • Los Angeles, California, United States, 90095
      • Palm Desert, California, United States, 92260
      • San Diego, California, United States, 92108
      • San Diego, California, United States, 92101
      • Santa Maria, California, United States, 93454
      • Torrance, California, United States, 90505
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
    • Florida
      • Aventura, Florida, United States, 33180
      • Boca Raton, Florida, United States, 33486
      • Fort Lauderdale, Florida, United States, 33334
      • Palm Habor, Florida, United States, 34684
      • Sarasota, Florida, United States, 34239
      • Tampa, Florida, United States, 33614
      • Tavares, Florida, United States, 32778
      • West Palm Beach, Florida, United States, 33407
      • Zephyrhills, Florida, United States, 33540
    • Georgia
      • Atlanta, Georgia, United States, 30342
    • Idaho
      • Boise, Idaho, United States, 83702
      • Meridian, Idaho, United States, 83642
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Springfield, Illinois, United States, 62704
      • Springfield, Illinois, United States, 62703
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5100
    • Kentucky
      • Bowling Green, Kentucky, United States, 42102
      • Elizabethtown, Kentucky, United States, 42701
      • Lexington, Kentucky, United States, 40515
      • Louisville, Kentucky, United States, 40202
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
    • Maine
      • Portland, Maine, United States, 04102
    • Maryland
      • Baltimore, Maryland, United States, 21201
      • Baltimore, Maryland, United States, 21205
      • Wheaton, Maryland, United States, 20902
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
      • Worcester, Massachusetts, United States, 01605
    • Michigan
      • Lansing, Michigan, United States, 48910
    • Minnesota
      • Duluth, Minnesota, United States, 55805
      • Rochester, Minnesota, United States, 55905
    • Mississippi
      • Tupelo, Mississippi, United States, 38802
    • Missouri
      • Saint Louis, Missouri, United States, 63141
      • Saint Louis, Missouri, United States, 63131
      • Saint Louis, Missouri, United States, 63128
      • St Louis, Missouri, United States, 63110
    • Montana
      • Billings, Montana, United States, 59107-5100
      • Missoula, Montana, United States, 59802
    • Nevada
      • Las Vegas, Nevada, United States, 89119
    • New Jersey
      • Medford, New Jersey, United States, 08055
      • Mercerville, New Jersey, United States, 08619
      • Teaneck, New Jersey, United States, 07666
    • New York
      • Albany, New York, United States, 12206
      • Binghamton, New York, United States, 13905
      • Great Neck, New York, United States, 11020
      • Johnson City, New York, United States, 13790
      • New York, New York, United States, 10021
      • New York, New York, United States, 10003
      • Orchard Park, New York, United States, 14127
      • Rochester, New York, United States, 14618
    • North Carolina
      • Asheville, North Carolina, United States, 28801
      • Chapel Hill, North Carolina, United States, 27599-7280
      • Charlotte, North Carolina, United States, 28210
      • Wilmington, North Carolina, United States, 28401
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
    • Ohio
      • Canton, Ohio, United States, 44718
      • Cincinnati, Ohio, United States, 45219
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
      • Tulsa, Oklahoma, United States, 74104
      • Tulsa, Oklahoma, United States, 74135
    • Oregon
      • Eugene, Oregon, United States, 97401
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, United States, 19004
      • Danville, Pennsylvania, United States, 17822
      • Duncansville, Pennsylvania, United States, 16635
      • Philadelphia, Pennsylvania, United States, 19152
      • Philadelphia, Pennsylvania, United States, 19140
      • Willow Grove, Pennsylvania, United States, 80045
    • South Carolina
      • Hickory, South Carolina, United States, 28602
    • Tennessee
      • Jackson, Tennessee, United States, 38305
    • Texas
      • Austin, Texas, United States, 78705
      • Dallas, Texas, United States, 75231
      • Dallas, Texas, United States, 75231-4406
      • Houston, Texas, United States, 77074
    • Utah
      • Ogden, Utah, United States, 84403
    • Virginia
      • Norfolk, Virginia, United States, 23502
      • Richmond, Virginia, United States, 23298
      • Salem, Virginia, United States, 24153
    • Washington
      • Seattle, Washington, United States, 98104
      • Seattle, Washington, United States, 98195
    • Wisconsin
      • Glendale, Wisconsin, United States, 53217

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 current anti-rheumatic therapies, including MTX;
  • inadequate response or intolerance to treatment with 1 or more anti-TNF therapies within 1 year of entering study;
  • on stable MTX 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 screening, or planned major surgery within 6 months after entering study;
  • 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
Drug: Methotrexate
10-25mg weekly
Drug: tocilizumab [RoActemra/Actemra]
4mg/kg iv every 4 weeks
Experimental: 2
Drug: tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks
Drug: Methotrexate
10-25mg weekly
Drug: tocilizumab [RoActemra/Actemra]
4mg/kg iv every 4 weeks
Placebo Comparator: 3
Drug: Placebo
iv every 4 weeks
Drug: Methotrexate
10-25mg weekly

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
AEs, laboratory parameters, vital signs, ECGs.
Time Frame: Throughout study
Throughout study

Secondary Outcome Measures

Outcome Measure
Time Frame
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

May 1, 2005

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 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

  • WA18062

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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