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

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.
623

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

  • 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

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 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

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]
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

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

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
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

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 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.
October 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.
June 11, 2010

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.
June 10, 2010

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.
June 1, 2010

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.
  • 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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