Status:
COMPLETED
A Study of the Effects of RoActemra/Actemra on Vaccination in Patients With Rheumatoid Arthritis on Background Methotrexate (VISARA)
Lead Sponsor:
Genentech, Inc.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
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 metho...
Eligibility Criteria
Inclusion
- 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- Other disease-modifying antirheumatic drugs (DMARDs) must be withdrawn before baseline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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT01163747
Start Date
September 1 2010
End Date
June 1 2012
Last Update
December 7 2012
Active Locations (47)
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1
Anniston, Alabama, United States, 36207
2
Birmingham, Alabama, United States, 35294
3
Huntsville, Alabama, United States, 35801
4
Glendale, Arizona, United States, 85304