A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis

January 10, 2013 updated by: Hoffmann-La Roche

A Multi-center, Randomized, Blinded, Parallel-group Study of the Reduction of Signs and Symptoms During Monotherapy Treatment With Tocilizumab 8 mg/kg Intravenously Versus Adalimumab 40 mg Subcutaneously in Patients With Rheumatoid Arthritis

This randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab (RoActemra/Actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis who are intolerant of methotrexate or where continued treatment with methotrexate was considered inappropriate. Patients were randomized to receive either tocilizumab 8 mg/kg intravenously (iv) every 4 weeks plus placebo subcutaneously (sc) every 2 weeks, or adalimumab 40 mg sc every 2 weeks plus placebo iv every 4 weeks. Treatment was anticipated to last 24 weeks. With regard to the blind, the study nurse was unblinded due to the nature of the treatment administration, but the investigator and the patient remained blinded.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

326

Phase

  • Phase 4

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
      • Maroochydore, Australia, 4558
      • Sydney, Australia, 2050
  • Belgium
      • Bruxelles, Belgium, 1070
      • Liege, Belgium, 4000
  • Brazil
      • Curitiba, Brazil, 80060-240
      • Goiania, Brazil, 74110010
      • Sao Paulo, Brazil, 04266-010
  • Czech Republic
      • Prague, Czech Republic, 12850
  • Finland
      • Helsinki, Finland, 00290
      • Jyväskylä, Finland, 40100
  • Germany
      • Baden-baden, Germany, 76530
      • Berlin, Germany, 14059
      • Essen, Germany, 45239
      • Heidelberg, Germany, 69120
      • Herne, Germany, 44652
      • Hildesheim, Germany, 31134
      • Köln, Germany, 50924
      • Osnabrück, Germany, 49074
      • Ratingen, Germany, 40882
      • Würzburg, Germany, 97080
  • Greece
      • Athens, Greece, 11527
      • Heraklion, Greece, 71110
      • Thessaloniki, Greece, 54642
  • Mexico
      • Mexicali, Mexico, 21100
      • Mexico, Df, Mexico, 11850
      • Obregon, Mexico, 85000
  • Portugal
      • Almada, Portugal, 2801-951
      • Lisboa, Portugal, 1649-035
      • Porto, Portugal, 4200-319
  • Spain
      • Barcelona, Spain, 08036
      • La Coruna, Spain, 15006
      • Madrid, Spain, 28006
      • Santiago de Compostela, Spain, 15705
      • Sevilla, Spain, 41009
  • Sweden
      • Stockholm, Sweden, 17176
      • Uppsala, Sweden, 751 85
  • Switzerland
      • Aarau, Switzerland, 5000
      • Genève, Switzerland, 1211
      • Lausanne, Switzerland, 1011
      • St. Gallen, Switzerland, 9007
      • Zürich, Switzerland, 8091
  • Turkey
      • Ankara, Turkey, 06100
      • Antalya, Turkey, 07059
      • Istanbul, Turkey, 34098
  • United Kingdom
      • Cannock, United Kingdom, WS11 5XY
      • Leeds, United Kingdom, LS7 4SA
      • London, United Kingdom, E11 1NR
      • Newcastle Upon Tyne, United Kingdom, NE1 4LP
      • Poole, United Kingdom, BH15 2JB
  • United States
    • Alabama
      • Aniston, Alabama, United States, 36207
      • Birmingham, Alabama, United States, 35294
    • Arizona
      • Scottsdale, Arizona, United States, 85258
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
      • Little Rock, Arkansas, United States, 72205
    • California
      • San Diego, California, United States, 92108
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
    • Connecticut
      • Trumbull, Connecticut, United States, 06611
    • Florida
      • Boca Raton, Florida, United States, 33486
      • Fort Lauderdale, Florida, United States, 33334
      • Ormond Beach, Florida, United States, 32174
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
    • Illinois
      • Springfield, Illinois, United States, 62704
    • Maryland
      • Cumberland, Maryland, United States, 21502
    • Mississippi
      • Flowood, Mississippi, United States, 39232
      • Tupelo, Mississippi, United States, 38802
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
    • New Hampshire
      • Dover, New Hampshire, United States, 03820
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
    • North Carolina
      • Hickory, North Carolina, United States, 28601
    • Ohio
      • Dayton, Ohio, United States, 45402
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
      • Willow Grove, Pennsylvania, United States, 19090
      • Wyomissing, Pennsylvania, United States, 19610
    • South Carolina
      • Greenville, South Carolina, United States, 29601
    • Tennessee
      • Hixson, Tennessee, United States, 37343
    • Texas
      • Houston, Texas, United States, 77074
      • Lubbock, Texas, United States, 79424
      • Mesquite, Texas, United States, 75150
      • Nassau Bay, Texas, United States, 77058
      • Waco, Texas, United States, 76708
    • Washington
      • Spokane, Washington, United States, 99204
      • Tacoma, Washington, United States, 98405

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, ≥ 18 years of age.
  • Rheumatoid arthritis of > 6 months duration.
  • Intolerant of methotrexate or continued treatment with methotrexate is considered inappropriate.
  • All disease-modifying anti-rheumatic drugs (DMARD) are to be withdrawn prior to receiving study drug.
  • Weight ≤ 150 kg.

Exclusion Criteria:

  • Major surgery (including joint surgery) within 12 weeks prior to baseline or planned major surgery within 6 months after baseline.
  • History of or current inflammatory joint disease other than rheumatoid arthritis (RA).
  • Treatment with a biologic agent at any time prior to baseline.
  • Intra-articular or parenteral corticosteroids ≤ 4 weeks prior to baseline.
  • Active current infection or history of recurrent bacterial, viral, fungal or mycobacterial infection.

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tocilizumab 8 mg/kg
Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
Drug: Tocilizumab
The maximum dose was 800 mg for patients weighing more than 100 kg. Tocilizumab was infused into an arm vein over a 1-hour period.
Other Names:
  • RoActemra
  • Actemra
Drug: Placebo to adalimumab
ACTIVE_COMPARATOR: Adalimumab 40 mg
Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
Drug: Adalimumab
Drug: Placebo to tocilizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28)
Time Frame: Baseline to Week 24
The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement. The analysis was adjusted for stratification factors of duration of RA (≤ 2 years and > 2 years) and region (US and non-US).
Baseline to Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With a Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Week 24
Time Frame: Week 24
The percentage of patients who achieved remission of their rheumatic arthritis at Week 24, as measured by a DAS28 score < 2.6, is reported.
Week 24
Percentage of Patients With Low Disease Activity (Disease Activity Score 28 [DAS28] ≤ 3.2) at Week 24
Time Frame: Week 24
The percentage of patients who had low rheumatic arthritis disease activity at Week 24, as measured by a DAS28 score of 3.2 or less, is reported.
Week 24
Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24
Time Frame: Baseline to Week 24
Improvement must be seen in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line "no disease activity" [symptom-free and no arthritis symptoms] and the extreme right end "maximum disease activity"; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line "no pain" and the extreme right end "unbearable pain"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.
Baseline to Week 24
Percentage of Patients With a European League Against Rheumatism (EULAR) Good Response at Week 24
Time Frame: Baseline to Week 24
Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.
Baseline to Week 24
Percentage of Patients With a European League Against Rheumatism (EULAR) Good or Moderate Response at Week 24
Time Frame: Baseline to Week 24
Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.
Baseline to 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, 2010

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

April 1, 2010

First Submitted That Met QC Criteria

May 6, 2010

First Posted (ESTIMATE)

May 10, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 11, 2013

Last Update Submitted That Met QC Criteria

January 10, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WA19924
  • 2009-015845-21

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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