Clinical trial NCT01119859: A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-05-10
Enrollment: 326
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, 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.


Eligibility criteria: 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* All disease-modifying anti-rheumatic drugs (DMARD) are to be withdrawn prior to receiving study drug.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.

Primary outcomes:
measure: Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28)
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Percentage of Patients With a Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Week 24
timeFrame: Week 24
measure: Percentage of Patients With Low Disease Activity (Disease Activity Score 28 [DAS28] ≤ 3.2) at Week 24
timeFrame: Week 24
measure: 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
timeFrame: Baseline to Week 24
measure: Percentage of Patients With a European League Against Rheumatism (EULAR) Good Response at Week 24
timeFrame: Baseline to Week 24
measure: Percentage of Patients With a European League Against Rheumatism (EULAR) Good or Moderate Response at Week 24
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Aniston
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Scottsdale
country: United States
state: Arizona
city: Hot Springs
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: San Diego
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Trumbull
country: United States
state: Connecticut
city: Boca Raton
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Ormond Beach
country: United States
state: Florida
city: Idaho Falls
country: United States
state: Idaho
city: Springfield
country: United States
state: Illinois
city: Cumberland
country: United States
state: Maryland
city: Flowood
country: United States
state: Mississippi
city: Tupelo
country: United States
state: Mississippi
city: Lincoln
country: United States
state: Nebraska
city: Dover
country: United States
state: New Hampshire
city: New Brunswick
country: United States
state: New Jersey
city: Hickory
country: United States
state: North Carolina
city: Dayton
country: United States
state: Ohio
city: Duncansville
country: United States
state: Pennsylvania
city: Willow Grove
country: United States
state: Pennsylvania
city: Wyomissing
country: United States
state: Pennsylvania
city: Greenville
country: United States
state: South Carolina
city: Hixson
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: Mesquite
country: United States
state: Texas
city: Nassau Bay
country: United States
state: Texas
city: Waco
country: United States
state: Texas
city: Spokane
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Maroochydore
country: Australia
city: Sydney
country: Australia
city: Bruxelles
country: Belgium
city: Liege
country: Belgium
city: Curitiba
country: Brazil
city: Goiania
country: Brazil
city: Sao Paulo
country: Brazil
city: Prague
country: Czech Republic
city: Helsinki
country: Finland
city: Jyväskylä
country: Finland
city: Baden-baden
country: Germany
city: Berlin
country: Germany
city: Essen
country: Germany
city: Heidelberg
country: Germany
city: Herne
country: Germany
city: Hildesheim
country: Germany
city: Köln
country: Germany
city: Osnabrück
country: Germany
city: Ratingen
country: Germany
city: Würzburg
country: Germany
city: Athens
country: Greece
city: Heraklion
country: Greece
city: Thessaloniki
country: Greece
city: Mexicali
country: Mexico
city: Mexico, Df
country: Mexico
city: Obregon
country: Mexico
city: Almada
country: Portugal
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Barcelona
country: Spain
city: La Coruna
country: Spain
city: Madrid
country: Spain
city: Santiago de Compostela
country: Spain
city: Sevilla
country: Spain
city: Stockholm
country: Sweden
city: Uppsala
country: Sweden
city: Aarau
country: Switzerland
city: Genève
country: Switzerland
city: Lausanne
country: Switzerland
city: St. Gallen
country: Switzerland
city: Zürich
country: Switzerland
city: Ankara
country: Turkey
city: Antalya
country: Turkey
city: Istanbul
country: Turkey
city: Cannock
country: United Kingdom
city: Leeds
country: United Kingdom
city: London
country: United Kingdom
city: Newcastle Upon Tyne
country: United Kingdom
city: Poole
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Strand V, Michalska M, Birchwood C, Pei J, Tuckwell K, Finch R, Gabay C, Kavanaugh A, Jones G. Impact of tocilizumab monotherapy on patient-reported outcomes in patients with rheumatoid arthritis from two randomised controlled trials. RMD Open. 2017 Sep 14;3(2):e000496. doi: 10.1136/rmdopen-2017-000496. eCollection 2017.
citation: Gabay C, McInnes IB, Kavanaugh A, Tuckwell K, Klearman M, Pulley J, Sattar N. Comparison of lipid and lipid-associated cardiovascular risk marker changes after treatment with tocilizumab or adalimumab in patients with rheumatoid arthritis. Ann Rheum Dis. 2016 Oct;75(10):1806-12. doi: 10.1136/annrheumdis-2015-207872. Epub 2015 Nov 27.
citation: Dennis G Jr, Holweg CT, Kummerfeld SK, Choy DF, Setiadi AF, Hackney JA, Haverty PM, Gilbert H, Lin WY, Diehl L, Fischer S, Song A, Musselman D, Klearman M, Gabay C, Kavanaugh A, Endres J, Fox DA, Martin F, Townsend MJ. Synovial phenotypes in rheumatoid arthritis correlate with response to biologic therapeutics. Arthritis Res Ther. 2014;16(2):R90. doi: 10.1186/ar4555. Epub 2014 Apr 30.
citation: Gabay C, Emery P, van Vollenhoven R, Dikranian A, Alten R, Pavelka K, Klearman M, Musselman D, Agarwal S, Green J, Kavanaugh A; ADACTA Study Investigators. Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised, double-blind, controlled phase 4 trial. Lancet. 2013 May 4;381(9877):1541-50. doi: 10.1016/S0140-6736(13)60250-0. Epub 2013 Mar 18.