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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


Phase 4
18 Years
64 Years
Not Enrolling
Both
Rheumatoid Arthritis

Thank you

Trial Information

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


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- Other disease-modifying antirheumatic drugs (DMARDs) must be withdrawn before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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Description:

Serum levels of antibody to pneumococcal vaccine were drawn 5 weeks after vaccination with 23-valent pneumococcal polysaccharide vaccine to assess humoral immune response. A positive response to the pneumococcal vaccine was defined as a 2-fold increase in serum antibody titers from Baseline or an increase of > 1 mg/L from Baseline levels. The 12 serotypes evaluated were pneumococcal serotypes 1, 3, 4, 6B, 8, 9N, 12F, 14, 19F, 23F, 7F, and 18C.

Outcome Time Frame:

Baseline (Week 3) and Week 8 (5 weeks post-vaccination)

Safety Issue:

No

Principal Investigator

Micki Klearman, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

NA25256

NCT ID:

NCT01163747

Start Date:

September 2010

Completion Date:

June 2012

Related Keywords:

  • Rheumatoid Arthritis
  • Arthritis
  • Arthritis, Rheumatoid

Name

Location

Hinsdale, Illinois  60521
New Britain, Connecticut  06052
Birmingham, Alabama  35294
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
Little Rock, Arkansas  72205-7199
Hackensack, New Jersey  07601
Baltimore, Maryland  21287
Charlotte, North Carolina  
Eugene, Oregon  
Indianapolis, Indiana  
Charleston, South Carolina  
Charleston, West Virginia  25304
Las Vegas, Nevada  89109
Jackson, Mississippi  
Coeur D'alene, Idaho  83814