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A Study of the Effects of RoActemra/Actemra on Vaccination in Patients With Rheumatoid Arthritis on Background Methotrexate (VISARA)

Information source: Genentech, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: tocilizumab (Biological); methotrexate (Drug); 23-Valent Pneumococcal Polysaccharide Vaccine (Biological); Tetanus Toxoid Adsorbed Vaccine (Biological)

Phase: Phase 4

Status: Completed

Sponsored by: Genentech, Inc.

Official(s) and/or principal investigator(s):
Micki Klearman, M.D., Study Director, Affiliation: Genentech, Inc.

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Participants Who Responded to ≥ 6 of 12 Anti-pneumococcal Antibody Serotypes

Secondary outcome:

Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes

Percentage of Participants With a Positive Response to Tetanus Toxoid Vaccination

Change From Baseline in Levels of Anti-pneumococcal Antibody 5 Weeks After Vaccination

Change From Baseline in Levels of Anti-tetanus Antibody 5 Weeks After Vaccination

Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes

Number of Participants With Adverse Events Through Week 8

Eligibility

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

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

Locations and Contacts

Anniston, Alabama 36207, United States

Birmingham, Alabama 35294, United States

Huntsville, Alabama 35801, United States

Glendale, Arizona 85304, United States

Mesa, Arizona 85202, United States

Paradise Valley, Arizona 85253, United States

Paradise Valley, Arizona 85037, United States

Scottsdale, Arizona 85258, United States

Jonesboro, Arkansas 72401, United States

Fullerton, California 92835, United States

Hemet, California 92543, United States

San Leandro, California 94578, United States

Santa Maria, California 93454, United States

Upland, California 91786, United States

Bridgeport, Connecticut 06606, United States

Melbourne, Florida 32901, United States

South Miami, Florida 33143, United States

Tavares, Florida 32778, United States

Boise, Idaho 83702, United States

Idaho Falls, Idaho 83404, United States

Maywood, Illinois 60153, United States

Vernon Hills, Illinois 60061, United States

South Bend, Indiana 46601, United States

Baltimore, Maryland 21224, United States

Baltimore, Maryland 21286, United States

Saint Clair Shores, Michigan 48080, United States

Tupelo, Mississippi 38801, United States

Las Vegas, Nevada 89128, United States

Manalapan, New Jersey 07726, United States

Albany, New York 12206, United States

Belmont, North Carolina 28012, United States

Charlotte, North Carolina 28210, United States

Greenville, North Carolina 27834, United States

Cleveland, Ohio 44109, United States

Gallipolis, Ohio 45631, United States

Middleburg Heights, Ohio 44130, United States

Lake Oswego, Oregon 97035, United States

Duncansville, Pennsylvania 16635, United States

Philadelphia, Pennsylvania 19152, United States

Wexford, Pennsylvania 15090, United States

Wyomissing, Pennsylvania 19610, United States

Charleston, South Carolina 29407, United States

Orangeburg, South Carolina 29118, United States

Dallas, Texas 75246, United States

Mesquite, Texas 75150, United States

Tacoma, Washington 98405, United States

Clarksburg, West Virginia 26301, United States

Additional Information

Starting date: September 2010
Last updated: November 12, 2012

Page last updated: August 23, 2015

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