Rheumatoid Arthritis
Conditions
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.
Interventions
BIOLOGICALtocilizumab
Intravenous repeating dose
DRUGmethotrexate
A stable dose of between 7.5 and 25 mg/week, oral or parenteral.
Intramuscular or subcutaneous injection
BIOLOGICALTetanus Toxoid Adsorbed Vaccine
Intramuscular injection
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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at stable dose of 7.5-25 mg/week (oral or parenteral) * Other disease-modifying antirheumatic drugs (DMARDs) must be withdrawn before baseline * Oral corticosteroids must be at stable dose of \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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Responded to ≥ 6 of 12 Anti-pneumococcal Antibody Serotypes | Baseline (Week 3) and Week 8 (5 weeks post-vaccination) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Positive Response to Tetanus Toxoid Vaccination | Baseline (Week 3) and Week 8 (5 weeks post-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. |
| Change From Baseline in Levels of Anti-pneumococcal Antibody 5 Weeks After Vaccination | Baseline (Week 3) and Week 8 (5 weeks post-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). |
| Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes | Baseline (Week 3) and Week 8 (5 weeks post-vaccination) | 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. |
| Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes | Baseline (Week 3) and Week 8 (5 weeks post-vaccination) | 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. |
| Number of Participants With Adverse Events Through Week 8 | 8 weeks | 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. |
| Change From Baseline in Levels of Anti-tetanus Antibody 5 Weeks After Vaccination | Baseline (Week 3) and Week 8 (5 weeks post-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). |
Countries
United States
Participant flow
Pre-assignment details
This study was conducted at 35 centers in the United States. Among the 112 patients screened, 91 patients were randomized in a 1:2 ratio to the methotrexate alone or to the tocilizumab + methotrexate treatment group.
Participants by arm
| Arm | Count |
|---|---|
| Methotrexate Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations. | 27 |
| Tocilizumab + Methotrexate Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations. | 54 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 5 |
| Overall Study | Insufficient Therapeutic Response | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Refused Treatment | 6 | 4 |
Baseline characteristics
| Characteristic | Methotrexate | Tocilizumab + Methotrexate | Total |
|---|---|---|---|
| Age Continuous | 51.4 years STANDARD_DEVIATION 9.47 | 51.1 years STANDARD_DEVIATION 8.9 | 51.2 years STANDARD_DEVIATION 9.04 |
| Region of Enrollment United States | 27 participants | 54 participants | 81 participants |
| Sex: Female, Male Female | 22 Participants | 41 Participants | 63 Participants |
| Sex: Female, Male Male | 5 Participants | 13 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 31 | 25 / 60 |
| serious Total, serious adverse events | 1 / 31 | 3 / 60 |
Outcome results
Primary
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)
Population: Evaluable per protocol population for pneumococcal polysaccharide vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the pneumococcal vaccine.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Methotrexate | Percentage of Participants Who Responded to ≥ 6 of 12 Anti-pneumococcal Antibody Serotypes | 70.8 percentage of participants |
| Tocilizumab + Methotrexate | Percentage of Participants Who Responded to ≥ 6 of 12 Anti-pneumococcal Antibody Serotypes | 60.0 percentage of participants |
Secondary
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).
Time frame: Baseline (Week 3) and Week 8 (5 weeks post-vaccination)
Population: Evaluable per protocol population for pneumococcal polysaccharide vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the pneumococcal vaccine.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methotrexate | Change From Baseline in Levels of Anti-pneumococcal Antibody 5 Weeks After Vaccination | Change from Baseline | 216.1 mg/L | Standard Deviation 261.85 |
| Methotrexate | Change From Baseline in Levels of Anti-pneumococcal Antibody 5 Weeks After Vaccination | Baseline | 91.1 mg/L | Standard Deviation 122.91 |
| Methotrexate | Change From Baseline in Levels of Anti-pneumococcal Antibody 5 Weeks After Vaccination | Week 8 | 307.2 mg/L | Standard Deviation 270.25 |
| Tocilizumab + Methotrexate | Change From Baseline in Levels of Anti-pneumococcal Antibody 5 Weeks After Vaccination | Week 8 | 184.2 mg/L | Standard Deviation 197.99 |
| Tocilizumab + Methotrexate | Change From Baseline in Levels of Anti-pneumococcal Antibody 5 Weeks After Vaccination | Baseline | 73.9 mg/L | Standard Deviation 63.5 |
| Tocilizumab + Methotrexate | Change From Baseline in Levels of Anti-pneumococcal Antibody 5 Weeks After Vaccination | Change from Baseline | 110.2 mg/L | Standard Deviation 188.74 |
Secondary
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)
Population: Evaluable per protocol population for tetanus toxoid vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the tetanus toxoid vaccine.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methotrexate | Change From Baseline in Levels of Anti-tetanus Antibody 5 Weeks After Vaccination | Baseline | 2 IU/mL | Standard Deviation 1.3 |
| Methotrexate | Change From Baseline in Levels of Anti-tetanus Antibody 5 Weeks After Vaccination | Week 8 | 9 IU/mL | Standard Deviation 12.4 |
| Methotrexate | Change From Baseline in Levels of Anti-tetanus Antibody 5 Weeks After Vaccination | Change from Baseline | 7 IU/mL | Standard Deviation 12.3 |
| Tocilizumab + Methotrexate | Change From Baseline in Levels of Anti-tetanus Antibody 5 Weeks After Vaccination | Change from Baseline | 7 IU/mL | Standard Deviation 9 |
| Tocilizumab + Methotrexate | Change From Baseline in Levels of Anti-tetanus Antibody 5 Weeks After Vaccination | Baseline | 2 IU/mL | Standard Deviation 1.9 |
| Tocilizumab + Methotrexate | Change From Baseline in Levels of Anti-tetanus Antibody 5 Weeks After Vaccination | Week 8 | 9 IU/mL | Standard Deviation 9.2 |
Secondary
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
Population: All participants who received at least one dose of study treatment were included in the safety evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Methotrexate | Number of Participants With Adverse Events Through Week 8 | Any adverse event | 3 participants |
| Methotrexate | Number of Participants With Adverse Events Through Week 8 | Serious adverse event | 1 participants |
| Methotrexate | Number of Participants With Adverse Events Through Week 8 | Deaths | 0 participants |
| Methotrexate | Number of Participants With Adverse Events Through Week 8 | Withdrawals due to adverse events | 0 participants |
| Tocilizumab + Methotrexate | Number of Participants With Adverse Events Through Week 8 | Withdrawals due to adverse events | 1 participants |
| Tocilizumab + Methotrexate | Number of Participants With Adverse Events Through Week 8 | Any adverse event | 23 participants |
| Tocilizumab + Methotrexate | Number of Participants With Adverse Events Through Week 8 | Deaths | 0 participants |
| Tocilizumab + Methotrexate | Number of Participants With Adverse Events Through Week 8 | Serious adverse event | 2 participants |
Secondary
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)
Population: Evaluable per protocol population for pneumococcal polysaccharide vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the pneumococcal vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Methotrexate | Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes | Responded to ≥7 out of 12 serotypes | 58.3 percentage of participants |
| Methotrexate | Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes | Responded to ≥1 out of 12 serotypes | 87.5 percentage of participants |
| Methotrexate | Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes | Responded to ≥2 out of 12 serotypes | 87.5 percentage of participants |
| Methotrexate | Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes | Responded to ≥3 out of 12 serotypes | 83.3 percentage of participants |
| Methotrexate | Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes | Responded to ≥4 out of 12 serotypes | 83.3 percentage of participants |
| Methotrexate | Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes | Responded to ≥5 out of 12 serotypes | 83.3 percentage of participants |
| Methotrexate | Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes | Responded to ≥6 out of 12 serotypes | 70.8 percentage of participants |
| Methotrexate | Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes | Responded to ≥8 out of 12 serotypes | 58.3 percentage of participants |
| Methotrexate | Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes | Responded to ≥9 out of 12 serotypes | 45.8 percentage of participants |
| Methotrexate | Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes | Responded to ≥10 out of 12 serotypes | 29.2 percentage of participants |
| Methotrexate | Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes | Responded to ≥ 11 out of 12 serotypes | 20.8 percentage of participants |
| Methotrexate | Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes | Responded to 12 out of 12 serotypes | 8.3 percentage of participants |
| Tocilizumab + Methotrexate | Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes | Responded to ≥ 11 out of 12 serotypes | 12.0 percentage of participants |
| Tocilizumab + Methotrexate | Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes | Responded to ≥7 out of 12 serotypes | 54.0 percentage of participants |
| Tocilizumab + Methotrexate | Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes | Responded to ≥6 out of 12 serotypes | 60.0 percentage of participants |
| Tocilizumab + Methotrexate | Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes | Responded to ≥1 out of 12 serotypes | 90.0 percentage of participants |
| Tocilizumab + Methotrexate | Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes | Responded to ≥10 out of 12 serotypes | 20.0 percentage of participants |
| Tocilizumab + Methotrexate | Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes | Responded to ≥2 out of 12 serotypes | 86.0 percentage of participants |
| Tocilizumab + Methotrexate | Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes | Responded to ≥8 out of 12 serotypes | 38.0 percentage of participants |
| Tocilizumab + Methotrexate | Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes | Responded to ≥3 out of 12 serotypes | 80.0 percentage of participants |
| Tocilizumab + Methotrexate | Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes | Responded to 12 out of 12 serotypes | 6.0 percentage of participants |
| Tocilizumab + Methotrexate | Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes | Responded to ≥4 out of 12 serotypes | 74.0 percentage of participants |
| Tocilizumab + Methotrexate | Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes | Responded to ≥9 out of 12 serotypes | 32.0 percentage of participants |
| Tocilizumab + Methotrexate | Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes | Responded to ≥5 out of 12 serotypes | 66.0 percentage of participants |
Secondary
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)
Population: Evaluable per protocol population for pneumococcal polysaccharide vaccine. N indicates the number of participants with available data for each serotype. No imputation was performed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Methotrexate | Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes | Serotype 7F response [N=24, 49] | 66.7 percentage of participants |
| Methotrexate | Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes | Serotype 1 response [N=24, 49] | 79.2 percentage of participants |
| Methotrexate | Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes | Serotype 3 response [N=24, 49] | 62.5 percentage of participants |
| Methotrexate | Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes | Serotype 4 response [N=24, 50] | 33.3 percentage of participants |
| Methotrexate | Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes | Serotype 6B response [N=24, 50] | 58.3 percentage of participants |
| Methotrexate | Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes | Serotype 8 response [N=24, 49] | 75.0 percentage of participants |
| Methotrexate | Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes | Serotype 9N response [N=23, 50] | 73.9 percentage of participants |
| Methotrexate | Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes | Serotype 12F response [N=23, 49] | 21.7 percentage of participants |
| Methotrexate | Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes | Serotype 14 response [N=21, 50] | 57.1 percentage of participants |
| Methotrexate | Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes | Serotype 18C response [N=24, 50] | 79.2 percentage of participants |
| Methotrexate | Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes | Serotype 19F response [N=24, 50] | 70.8 percentage of participants |
| Methotrexate | Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes | Serotype 23F response [N=24, 50] | 50.0 percentage of participants |
| Tocilizumab + Methotrexate | Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes | Serotype 19F response [N=24, 50] | 54.0 percentage of participants |
| Tocilizumab + Methotrexate | Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes | Serotype 9N response [N=23, 50] | 56.0 percentage of participants |
| Tocilizumab + Methotrexate | Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes | Serotype 1 response [N=24, 49] | 65.3 percentage of participants |
| Tocilizumab + Methotrexate | Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes | Serotype 18C response [N=24, 50] | 64.0 percentage of participants |
| Tocilizumab + Methotrexate | Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes | Serotype 3 response [N=24, 49] | 53.1 percentage of participants |
| Tocilizumab + Methotrexate | Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes | Serotype 12F response [N=23, 49] | 26.5 percentage of participants |
| Tocilizumab + Methotrexate | Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes | Serotype 4 response [N=24, 50] | 38.0 percentage of participants |
| Tocilizumab + Methotrexate | Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes | Serotype 23F response [N=24, 50] | 44.0 percentage of participants |
| Tocilizumab + Methotrexate | Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes | Serotype 6B response [N=24, 50] | 46.0 percentage of participants |
| Tocilizumab + Methotrexate | Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes | Serotype 7F response [N=24, 49] | 61.2 percentage of participants |
| Tocilizumab + Methotrexate | Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes | Serotype 14 response [N=21, 50] | 56.0 percentage of participants |
| Tocilizumab + Methotrexate | Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes | Serotype 8 response [N=24, 49] | 59.2 percentage of participants |
Secondary
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)
Population: Evaluable per protocol population for tetanus toxoid vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the tetanus toxoid vaccine.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Methotrexate | Percentage of Participants With a Positive Response to Tetanus Toxoid Vaccination | 39.1 percentage of participants |
| Tocilizumab + Methotrexate | Percentage of Participants With a Positive Response to Tetanus Toxoid Vaccination | 42.0 percentage of participants |