Clinical trial NCT01283971: A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate (MTX) in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One Tumor Necrosis Factor (TNF)-Inhibitor
Official title: A Randomized, Open-label, Parallel-group Study of the Reduction of Signs and Symptoms During Treatment With Tocilizumab Versus Adalimumab, Both in Combination With MTX, in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to Treatment With Only One TNF Inhibitor
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-01-26
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, parallel-group study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) versus adalimumab, both in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients, already treated with MTX at stable doses, will be randomized to receive either RoActemra/Actemra 8 mg/kg intravenously (IV) every 4 weeks or adalimumab 40 mg subcutaneous (SC) every 2 weeks. All patients will receive methotrexate (10-25 mg weekly) and folate (at least 5 mg weekly). The anticipated time on study treatment is 24 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Rheumatoid arthritis of \>/= 6 months duration (according to American College of Rheumatology (ACR) criteria)(according to ACR criteria)
* Inadequate response due to inefficacy of treatment (for at least 3 months) with only one approved Tumor Necrosis Factor (TNF)-agent other than adalimumab Depending on the TNF-inhibitor, last dose of TNF-inhibitor should have been 1 to 8 weeks before randomization to the study
* On methotrexate treatment for \>/=12 weeks immediately prior to baseline, with stable dose (10-25 mg/week) for the last 8 weeks
* Disease Activity Score (DAS28) \>3.2 at baseline
* Oral corticosteroids (\</=10 mg/day prednisone or equivalent) and non-steroidal anti-inflammatory drugs (NSAIDs) are permitted if the dose has been stable for \>/=6 weeks prior to baseline.

Exclusion Criteria:

* Major surgery (including joint surgery) within 8 weeks prior to screening or planned surgery within 6 months following randomization
* Rheumatic autoimmune disease other than rheumatoid arthritis
* Prior history of or current inflammatory joint disease other than rheumatoid arthritis
* Functional class IV (ACR criteria)
* History of severe allergic reaction to human, humanized or murine monoclonal antibodies
* Known active current or history of recurrent infection (including tuberculosis)
* Primary or secondary immunodeficiency (history of or currently active)
* Body weight \>150 kg
* Previous treatment with any cell-depleting therapies
* Previous treatment with tocilizumab
* Intra-articular or parenteral corticosteroids within 6 weeks prior to baseline.

Primary outcomes:
measure: Percentage of Participants With Disease Activity Score 28 Joints (DAS28) Remission at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants With American College of Rheumatology (ACR20) Response at Week 24
timeFrame: Baseline, Week 24
measure: Percentage of Participants With ACR50 Response at Week 24
timeFrame: Baseline, Week 24
measure: Percentage of Participants With ACR70 Response at Week 24
timeFrame: Baseline, Week 24
measure: Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) DAS28 Responses at Week 24
timeFrame: Baseline, Week 24
measure: Percentage of Participants With DAS28 Low Disease Activity (LDAS) at Week 24
timeFrame: Week 24
measure: Change From Baseline in DAS28 Score at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Swollen Joint Count (SJC) at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Tender Joint Count (TJC) at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Patient Assessment of Pain Visual Analog Scale (VAS) at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in the Patient Global Assessment of Disease Activity VAS at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in the Physician Global Assessment of Disease Activity VAS at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) Score at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Quality of Life Short Form (SF-36) Score at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Score at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Hemoglobin at Week 24
timeFrame: Baseline, Week 24
measure: Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Discontinuation Due to AEs and Deaths
timeFrame: 32 weeks
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Covina
country: United States
state: California
city: Escondido
country: United States
state: California
city: Huntington Beach
country: United States
state: California
city: La Mesa
country: United States
state: California
city: Lakewood
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Westlake Village
country: United States
state: California
city: Whittier
country: United States
state: California
city: Whittier
country: United States
state: California
city: Bridgeport
country: United States
state: Connecticut
city: Hamden
country: United States
state: Connecticut
city: Norwich
country: United States
state: Connecticut
city: Newark
country: United States
state: Delaware
city: Aventura
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Ormond Beach
country: United States
state: Florida
city: Palm Habor
country: United States
state: Florida
city: Palm Harbor
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city: Sarasota
country: United States
state: Florida
city: Tamarac
country: United States
state: Florida
city: Tampa
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state: Florida
city: Atlanta
country: United States
state: Georgia
city: Valdosta
country: United States
state: Georgia
city: Idaho Falls
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Maywood
country: United States
state: Illinois
city: Moline
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: South Bend
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state: Indiana
city: Lexington
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: Monroe
country: United States
state: Louisiana
city: Annapolis
country: United States
state: Maryland
city: Cumberland
country: United States
state: Maryland
city: Frederick
country: United States
state: Maryland
city: Hagerstown
country: United States
state: Maryland
city: Fall River
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Battle Creek
country: United States
state: Michigan
city: Lansing
country: United States
state: Michigan
city: Petoskey
country: United States
state: Michigan
city: St. Claire Shores
country: United States
state: Michigan
city: Biloxi
country: United States
state: Mississippi
city: Flowood
country: United States
state: Mississippi
city: Tupelo
country: United States
state: Mississippi
city: Saint Louis
country: United States
state: Missouri
city: Springfield
country: United States
state: Missouri
city: Reno
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state: Nevada
city: Clifton
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state: New Jersey
city: Manalapan
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city: New Brunswick
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city: Brooklyn
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city: New York
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city: New York
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city: Syracuse
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state: New York
city: Charlotte
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: Greenville
country: United States
state: North Carolina
city: Raleigh
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state: North Carolina
city: Washington
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state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Middleburg Heights
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Lake Oswego
country: United States
state: Oregon
city: Duncansville
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Willow Grove
country: United States
state: Pennsylvania
city: Wynnewood
country: United States
state: Pennsylvania
city: Wyomissing
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Myrtle Beach
country: United States
state: South Carolina
city: Jackson
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Carrollton
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
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state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Mesquite
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Sugar Land
country: United States
state: Texas
city: Arlington
country: United States
state: Virginia
city: Kennewick
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Clarksburg
country: United States
state: West Virginia
city: Franklin
country: United States
state: Wisconsin
city: Alborg
country: Denmark
city: Helsingør
country: Denmark
city: Silkeborg
country: Denmark
city: Helsinki
country: Finland
city: Hyvinkää
country: Finland
city: Jyvaeskylae
country: Finland
city: Grenoble
country: France
city: Lille
country: France
city: Limoges
country: France
city: Metz
country: France
city: Montpellier
country: France
city: Mulhouse
country: France
city: Nantes
country: France
city: Orleans
country: France
city: Paris
country: France
city: Toulouse
country: France
city: Berlin
country: Germany
city: Düsseldorf
country: Germany
city: Erfurt
country: Germany
city: Erlangen
country: Germany
city: Frankfurt Am Main
country: Germany
city: Gommern
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Heidelberg
country: Germany
city: Herne
country: Germany
city: Hildesheim
country: Germany
city: München
country: Germany
city: Osnabrück
country: Germany
city: Regensburg
country: Germany
city: Rostock
country: Germany
city: Tübingen
country: Germany
city: Athens
country: Greece
city: Herakleion
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
city: Firenze
country: Italy
city: Milano
country: Italy
city: Pavia
country: Italy
city: Pisa
country: Italy
city: Roma
country: Italy
city: Nijmegen
country: Netherlands
city: Caguas
country: Puerto Rico
city: Kemerovo
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: UFA
country: Russian Federation
city: Ulyanovsk
country: Russian Federation
city: Oviedo
country: Spain
state: Asturias
city: Sabadell
country: Spain
state: Barcelona
city: La Coruna
country: Spain
state: La Coruña
city: Santiago de Compostela
country: Spain
state: La Coruña
city: Valenica
country: Spain
state: Valencia
city: Barakaldo
country: Spain
state: Vizcaya
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Goteborg
country: Sweden
city: Huddinge
country: Sweden
city: Lund
country: Sweden
city: Malmo
country: Sweden
city: Umea
country: Sweden
city: Västerås
country: Sweden
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: