Clinical trial NCT00531817: A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis
Official title: A Randomized, Double-blind, Parallel-group Study to Evaluate the Safety and Efficacy of Tocilizumab (TCZ) Versus Placebo in Combination With Disease Modifying Antirheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-09-19
Enrollment: 619
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 2-arm study assessed the safety and efficacy of tocilizumab versus placebo, both in combination with disease modifying antirheumatic drugs (DMARDs), in regard to reduction in signs and symptoms, in patients with moderate to severe active rheumatoid arthritis with an inadequate response to DMARDs. Patients were randomized in a ratio of 2:1 to receive either tocilizumab 8 mg/kg intravenously (IV) or placebo IV every 4 weeks. All patients also received stable antirheumatic therapy, including permitted DMARDs. The anticipated time on study treatment was 3-12 months and the target sample size was 500+ individuals.


Eligibility criteria: Inclusion Criteria:

* Adult patients, ≥18 years of age
* Active rheumatoid arthritis of \>6 months duration
* Received permitted DMARDs each at a stable dose for at least 7 weeks prior to baseline

Exclusion Criteria:

* Rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis
* Major surgery within 8 weeks prior to screening or planned within 6 months following randomization
* Unsuccessful treatment with a biologic agent, including an anti-TNF agent
* Previous treatment with tocilizumab

Primary outcomes:
measure: Percentage of Patients With an Improvement of at Least 50% in American College of Rheumatology (ACR) Score (ACR50) From Baseline at Week 24
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20, ACR50, ACR70) From Baseline at Weeks 4, 8, 12, 16, 20, and 24
timeFrame: Baseline to Weeks 4, 8, 12, 16, 20, 24
measure: Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 4, 8, 12, 16, 20, and 24
timeFrame: Baseline to Weeks 4, 8, 12, 16, 20, 24
measure: Percentage of Patients With European League Against Rheumatism (EULAR) Good, Moderate, or no Response at Weeks 4, 8, 12, 16, 20, and 24
timeFrame: Baseline to Weeks 4, 8, 12, 16, 20, and 24
measure: Mean Change From Baseline in the Routine Assessment Patient Index Data (RAPID) Score at Weeks 4, 8, 12, 16, 20, and 24
timeFrame: Baseline to Weeks 4, 8, 12, 16, 20, and 24
measure: Mean Change From Baseline in 12-Item Short Form Health Survey v2 (SF-12) Scores at Weeks 4, 8, 12, 16, 20, and 24
timeFrame: Baseline to Weeks 4, 8, 12, 16, 20, and 24
measure: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Weeks 4, 8, 12, 16, 20, and 24
timeFrame: Baseline to Weeks 4, 8, 12, 16, 20, and 24
measure: Mean Change From Baseline in the Medical Outcomes Study (MOS) Sleep Scale Score at Weeks 4, 8, 12, 16, 20, and 24
timeFrame: Baseline to Weeks 4, 8, 12, 16, 20, and 24
measure: Mean Change From Baseline in Individual Components of the Routine Assessment Patient Index Data (RAPID) at Each Day During the First 7 Days of Treatment
timeFrame: Baseline through Day 7
measure: Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20, ACR50, ACR70) From Baseline at Day 7
timeFrame: Baseline to Day 7
measure: Mean Change From Baseline in C-reactive Protein (CRP) at Days 3 and 7
timeFrame: Baseline to Days 3 and 7
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Birmingham
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state: Alabama
city: Montgomery
country: United States
state: Alabama
city: Lake Havasu City
country: United States
state: Arizona
city: Paradise Valley
country: United States
state: Arizona
city: Peoria
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Jonesboro
country: United States
state: Arkansas
city: Beverly Hills
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state: California
city: Escondido
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state: California
city: La Jolla
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state: California
city: Long Beach
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state: California
city: Los Angeles
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state: California
city: Pasadena
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state: California
city: Santa Maria
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state: California
city: Santa Monica
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state: California
city: Upland
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city: Colorado Springs
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city: Trumbull
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city: Fort Lauderdale
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city: Lake Mary
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city: Orlando
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city: Plantation
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city: Tampa
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city: Atlanta
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state: Georgia
city: Blue Ridge
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city: St Clair Shores
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city: New Brunswick
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city: Passaic
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city: Teaneck
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city: Mineola
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city: Orchard Park
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city: Charlotte
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city: Charlotte
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city: Durham
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city: Beechwood
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city: Middleburg Heights
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city: Perrysburg
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city: Zanesville
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state: Ohio
city: Norman
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state: Oklahoma
city: Oklahoma City
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city: Oklahoma City
country: United States
state: Oklahoma
city: Lake Oswego
country: United States
state: Oregon
city: Portland
country: United States
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city: Salem
country: United States
state: Oregon
city: Bethlehem
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
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state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Wexford
country: United States
state: Pennsylvania
city: Willow Grove
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Florence
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Myrtle Beach
country: United States
state: South Carolina
city: Rapid City
country: United States
state: South Dakota
city: Rapid City
country: United States
state: South Dakota
city: Sioux Falls
country: United States
state: South Dakota
city: Watertown
country: United States
state: South Dakota
city: Crossville
country: United States
state: Tennessee
city: Hendersonville
country: United States
state: Tennessee
city: Jackson
country: United States
state: Tennessee
city: Knoxville
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Amarillo
country: United States
state: Texas
city: Bellaire
country: United States
state: Texas
city: Carrollton
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
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: San Antonio
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Waco
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Burlington
country: United States
state: Vermont
city: Burke
country: United States
state: Virginia
city: Reston
country: United States
state: Virginia
city: Salem
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Beckley
country: United States
state: West Virginia
city: Clarksburg
country: United States
state: West Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: Onalaska
country: United States
state: Wisconsin
city: Wausau
country: United States
state: Wisconsin
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Yazici Y, Curtis JR, Ince A, Baraf HS, Lepley DM, Devenport JN, Kavanaugh A. Early effects of tocilizumab in the treatment of moderate to severe active rheumatoid arthritis: a one-week sub-study of a randomised controlled trial (Rapid Onset and Systemic Efficacy [ROSE] Study). Clin Exp Rheumatol. 2013 May-Jun;31(3):358-64. Epub 2013 Jan 10.
citation: Yazici Y, Curtis JR, Ince A, Baraf H, Malamet RL, Teng LL, Kavanaugh A. Efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis and a previous inadequate response to disease-modifying antirheumatic drugs: the ROSE study. Ann Rheum Dis. 2012 Feb;71(2):198-205. doi: 10.1136/ard.2010.148700. Epub 2011 Sep 26.