Clinical trial NCT01163747: A Study of the Effects of RoActemra/Actemra on Vaccination in Patients With Rheumatoid Arthritis on Background Methotrexate (VISARA)
Official title: A Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Effects of Tocilizumab on Vaccination in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2010-07-16
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, parallel-group, open-label study will evaluate the effect of Actemra (tocilizumab) on vaccination in patients with active rheumatoid arthritis who have an inadequate response to methotrexate and who have had an inadequate clinical response or were intolerant to treatment with one or more anti-tumor necrosis factor (anti-TNF) therapies.


Eligibility criteria: Inclusion Criteria:

* Adult patients, ≥ 18 to \< 65 years of age
* Rheumatoid Arthritis (RA) of \> 6 months duration at baseline (American College of Rheumatology criteria)
* Willing to receive immunization with pneumococcal polysaccharide and tetanus toxoid adsorbed vaccines
* Previous immunization with pneumococcal polysaccharide must have occurred ≥ 3 years of baseline, with tetanus containing vaccine ≥ 5 years
* Methotrexate therapy for at least 8 weeks prior to baseline at stable dose of 7.5-25 mg/week (oral or parenteral)
* Other disease-modifying antirheumatic drugs (DMARDs) must be withdrawn before baseline
* Oral corticosteroids must be at stable dose of \< 10 mg/day prednisone or equivalent
* Body weight ≤ 150 kg at screening

Exclusion Criteria:

* Major surgery (including joint surgery) within 12 weeks prior to baseline or planned major surgery within 8 weeks after baseline
* History of or current inflammatory joint disease or rheumatic autoimmune disease other than RA
* Pre-existing central nervous system demyelinating or seizure disorders
* Active current or history of recurrent bacterial, viral fungal, mycobacterial and other infections
* Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks prior to baseline or oral antibiotics within 2 weeks prior to baseline
* Active tuberculosis requiring treatment within 3 years prior to baseline
* Primary or secondary immunodeficiency (history or currently active)
* Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
* Previous treatment with RoActemra/Actemra

Primary outcomes:
measure: Percentage of Participants Who Responded to ≥ 6 of 12 Anti-pneumococcal Antibody Serotypes
timeFrame: Baseline (Week 3) and Week 8 (5 weeks post-vaccination)
Secondary outcomes:
measure: Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes
timeFrame: Baseline (Week 3) and Week 8 (5 weeks post-vaccination)
measure: Percentage of Participants With a Positive Response to Tetanus Toxoid Vaccination
timeFrame: Baseline (Week 3) and Week 8 (5 weeks post-vaccination)
measure: Change From Baseline in Levels of Anti-pneumococcal Antibody 5 Weeks After Vaccination
timeFrame: Baseline (Week 3) and Week 8 (5 weeks post-vaccination)
measure: Change From Baseline in Levels of Anti-tetanus Antibody 5 Weeks After Vaccination
timeFrame: Baseline (Week 3) and Week 8 (5 weeks post-vaccination)
measure: Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes
timeFrame: Baseline (Week 3) and Week 8 (5 weeks post-vaccination)
measure: Number of Participants With Adverse Events Through Week 8
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Anniston
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Glendale
country: United States
state: Arizona
city: Mesa
country: United States
state: Arizona
city: Paradise Valley
country: United States
state: Arizona
city: Paradise Valley
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Jonesboro
country: United States
state: Arkansas
city: Fullerton
country: United States
state: California
city: Hemet
country: United States
state: California
city: San Leandro
country: United States
state: California
city: Santa Maria
country: United States
state: California
city: Upland
country: United States
state: California
city: Bridgeport
country: United States
state: Connecticut
city: Melbourne
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Tavares
country: United States
state: Florida
city: Boise
country: United States
state: Idaho
city: Idaho Falls
country: United States
state: Idaho
city: Maywood
country: United States
state: Illinois
city: Vernon Hills
country: United States
state: Illinois
city: South Bend
country: United States
state: Indiana
city: Baltimore
country: United States
state: Maryland
city: Baltimore
country: United States
state: Maryland
city: Saint Clair Shores
country: United States
state: Michigan
city: Tupelo
country: United States
state: Mississippi
city: Las Vegas
country: United States
state: Nevada
city: Manalapan
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: Belmont
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Greenville
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Gallipolis
country: United States
state: Ohio
city: Middleburg Heights
country: United States
state: Ohio
city: Lake Oswego
country: United States
state: Oregon
city: Duncansville
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Wexford
country: United States
state: Pennsylvania
city: Wyomissing
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Orangeburg
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Mesquite
country: United States
state: Texas
city: Tacoma
country: United States
state: Washington
city: Clarksburg
country: United States
state: West Virginia
Study officials:
affiliation: Genentech, Inc.
name: Micki Klearman, M.D.
role: STUDY_DIRECTOR
References:
citation: Bingham CO 3rd, Rizzo W, Kivitz A, Hassanali A, Upmanyu R, Klearman M. Humoral immune response to vaccines in patients with rheumatoid arthritis treated with tocilizumab: results of a randomised controlled trial (VISARA). Ann Rheum Dis. 2015 May;74(5):818-22. doi: 10.1136/annrheumdis-2013-204427. Epub 2014 Jan 21.