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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
499

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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