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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
91
Intravenous repeating dose
A stable dose of between 7.5 and 25 mg/week, oral or parenteral.
Intramuscular or subcutaneous injection
Percentage of Participants Who Responded to ≥ 6 of 12 Anti-pneumococcal Antibody Serotypes
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.
Time frame: Baseline (Week 3) and Week 8 (5 weeks post-vaccination)
Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes
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.
Time frame: Baseline (Week 3) and Week 8 (5 weeks post-vaccination)
Percentage of Participants With a Positive Response to Tetanus Toxoid Vaccination
A positive response to the tetanus toxoid vaccination was defined as antibody levels ≥ 0.2 IU/mL for participants with Baseline tetanus antibody levels \< 0.1 IU/mL, or a 4-fold increase in antibody levels compared with Baseline for participants with Baseline tetanus antibody levels ≥ 0.1 IU/mL.
Time frame: Baseline (Week 3) and Week 8 (5 weeks post-vaccination)
Change From Baseline in Levels of Anti-pneumococcal Antibody 5 Weeks After Vaccination
Levels of anti-pneumococcal antibodies were measured by a central laboratory from serum samples taken prior to vaccination (Week 3) and 5 weeks post vaccination (Week 8).
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Intramuscular injection
Unnamed facility
Anniston, Alabama, United States
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Huntsville, Alabama, United States
Unnamed facility
Glendale, Arizona, United States
Unnamed facility
Mesa, Arizona, United States
Unnamed facility
Paradise Valley, Arizona, United States
Unnamed facility
Paradise Valley, Arizona, United States
Unnamed facility
Scottsdale, Arizona, United States
Unnamed facility
Jonesboro, Arkansas, United States
Unnamed facility
Fullerton, California, United States
...and 37 more locations
Time frame: Baseline (Week 3) and Week 8 (5 weeks post-vaccination)
Change From Baseline in Levels of Anti-tetanus Antibody 5 Weeks After Vaccination
Levels of anti-tetanus antibodies were measured by a central laboratory from serum samples taken prior to vaccination (Week 3) and 5 weeks post vaccination (Week 8).
Time frame: Baseline (Week 3) and Week 8 (5 weeks post-vaccination)
Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes
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, 7F, 8, 9N, 12F, 14, 18C, 19F and 23F.
Time frame: Baseline (Week 3) and Week 8 (5 weeks post-vaccination)
Number of Participants With Adverse Events Through Week 8
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) is any AE that is fatal or is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Time frame: 8 weeks