Trial Outcomes & Findings for A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate (NCT NCT00282308)
NCT ID: NCT00282308
Last Updated: 2017-08-10
Results Overview
The immune response to tetanus toxoid adsorbed booster vaccine was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The tetanus antibody test was an ELISA that used tetanus toxoid as a capturing reagent and alkaline phosphatase-conjugated anti-human IgG (γ) for detection. For patients with pre-vaccination tetanus antibody titers \< 0.1 IU/mL, a positive immune response was defined as an antibody titer ≥ 0.2 IU/mL. For patients with pre-vaccination tetanus antibody titers ≥ 0.1 IU/mL, a positive immune response to the booster immunization was defined as a 4-fold increase in antibody titer.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
103 participants
Primary outcome timeframe
Week 24 to Week 28 for Group A and Day 1 to Week 4 for Group B
Results posted on
2017-08-10
Participant Flow
Participant milestones
| Measure |
Rituximab + Methotrexate (Group A)
Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
Methotrexate (Group B)
Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
All Patients (Combined Groups A and B)
Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab. Patients received no treatment during the Safety Follow-up Period.
|
|---|---|---|---|
|
Treatment Period
STARTED
|
69
|
34
|
0
|
|
Treatment Period
COMPLETED
|
65
|
28
|
0
|
|
Treatment Period
NOT COMPLETED
|
4
|
6
|
0
|
|
Optional Extension Re-treatment Period
STARTED
|
0
|
0
|
78
|
|
Optional Extension Re-treatment Period
COMPLETED
|
0
|
0
|
72
|
|
Optional Extension Re-treatment Period
NOT COMPLETED
|
0
|
0
|
6
|
|
Safety Follow-up Period
STARTED
|
0
|
0
|
100
|
|
Safety Follow-up Period
COMPLETED
|
0
|
0
|
81
|
|
Safety Follow-up Period
NOT COMPLETED
|
0
|
0
|
19
|
Reasons for withdrawal
| Measure |
Rituximab + Methotrexate (Group A)
Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
Methotrexate (Group B)
Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
All Patients (Combined Groups A and B)
Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab. Patients received no treatment during the Safety Follow-up Period.
|
|---|---|---|---|
|
Treatment Period
Lost to Follow-up
|
1
|
0
|
0
|
|
Treatment Period
Subject/Guardian Decision to Withdraw
|
2
|
4
|
0
|
|
Treatment Period
Adverse Event
|
0
|
2
|
0
|
|
Treatment Period
Not Treated with Study Drug
|
1
|
0
|
0
|
|
Optional Extension Re-treatment Period
Adverse Event
|
0
|
0
|
4
|
|
Optional Extension Re-treatment Period
Physician's Decision to Withdraw
|
0
|
0
|
1
|
|
Optional Extension Re-treatment Period
Subject/Guardian Decision to Withdraw
|
0
|
0
|
1
|
|
Safety Follow-up Period
Adverse Event
|
0
|
0
|
1
|
|
Safety Follow-up Period
Lost to Follow-up
|
0
|
0
|
5
|
|
Safety Follow-up Period
Physician Decision to Withdraw
|
0
|
0
|
1
|
|
Safety Follow-up Period
Subject/Guardian Decision to Withdraw
|
0
|
0
|
12
|
Baseline Characteristics
A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate
Baseline characteristics by cohort
| Measure |
Rituximab + Methotrexate (Group A)
n=68 Participants
Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
Methotrexate (Group B)
n=32 Participants
Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.7 years
STANDARD_DEVIATION 9.60 • n=5 Participants
|
49.7 years
STANDARD_DEVIATION 10.51 • n=7 Participants
|
49.7 years
STANDARD_DEVIATION 9.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24 to Week 28 for Group A and Day 1 to Week 4 for Group BPopulation: Immune response per-protocol population: Group A - All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B - All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.
The immune response to tetanus toxoid adsorbed booster vaccine was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The tetanus antibody test was an ELISA that used tetanus toxoid as a capturing reagent and alkaline phosphatase-conjugated anti-human IgG (γ) for detection. For patients with pre-vaccination tetanus antibody titers \< 0.1 IU/mL, a positive immune response was defined as an antibody titer ≥ 0.2 IU/mL. For patients with pre-vaccination tetanus antibody titers ≥ 0.1 IU/mL, a positive immune response to the booster immunization was defined as a 4-fold increase in antibody titer.
Outcome measures
| Measure |
Rituximab + Methotrexate (Group A)
n=64 Participants
Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
Methotrexate (Group B)
n=26 Participants
Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
|---|---|---|
|
Percentage of Patients With a Positive Immune Response to Tetanus Toxoid Adsorbed Booster Vaccine
|
39.1 Percentage of patients
|
42.3 Percentage of patients
|
SECONDARY outcome
Timeframe: Week 24 to Week 28 for Group A and Day 1 to Week 4 for Group BPopulation: Immune response per-protocol population: Group A - All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B - All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.
The immune response to tetanus toxoid adsorbed booster vaccine was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The tetanus antibody test was an ELISA that used tetanus toxoid as a capturing reagent and alkaline phosphatase-conjugated anti-human IgG (γ) for detection.
Outcome measures
| Measure |
Rituximab + Methotrexate (Group A)
n=64 Participants
Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
Methotrexate (Group B)
n=26 Participants
Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
|---|---|---|
|
Percentage of Patients With a 2-fold Increase in Tetanus Antibody Titers or With Tetanus Antibody Titers ≥ 0.2 IU/mL in Response to Tetanus Toxoid Adsorbed Booster Vaccine
|
54.7 Percentage of patients
|
61.5 Percentage of patients
|
SECONDARY outcome
Timeframe: Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group BPopulation: Immune response per-protocol population: Group A - All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B - All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.
The immune response to each of the 12 anti-pneumococcal antibody serotypes was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The pneumococcal antibody assay was a fluoroimmunoassay that used a Luminex Multiplex platform. Purified capsular polysaccharides isolated from 12 serotypes of S. pneumonia were covalently attached to microbeads and used as a capturing reagent. Phycoerythrin conjugated anti-human IgG was used for detection. A positive immune response against a serotype was defined as a 2-fold increase or an increase of \> 1 μg/mL from pre-vaccination levels.
Outcome measures
| Measure |
Rituximab + Methotrexate (Group A)
n=63 Participants
Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
Methotrexate (Group B)
n=28 Participants
Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
|---|---|---|
|
Percentage of Patients With a Positive Immune Response to Each of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine
Serotype 1-146 (1)
|
12.7 Percentage of patients
|
42.9 Percentage of patients
|
|
Percentage of Patients With a Positive Immune Response to Each of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine
Serotype 3-146 (3)
|
9.5 Percentage of patients
|
28.6 Percentage of patients
|
|
Percentage of Patients With a Positive Immune Response to Each of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine
Serotype 4-146 (4)
|
12.7 Percentage of patients
|
60.7 Percentage of patients
|
|
Percentage of Patients With a Positive Immune Response to Each of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine
Serotype 51-146 (7F)
|
25.4 Percentage of patients
|
60.7 Percentage of patients
|
|
Percentage of Patients With a Positive Immune Response to Each of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine
Serotype 56-146 (18C)
|
20.6 Percentage of patients
|
57.1 Percentage of patients
|
|
Percentage of Patients With a Positive Immune Response to Each of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine
Serotype 12-146 (12F)
|
11.1 Percentage of patients
|
50.0 Percentage of patients
|
|
Percentage of Patients With a Positive Immune Response to Each of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine
Serotype 6/26-146 (6B)
|
38.1 Percentage of patients
|
60.7 Percentage of patients
|
|
Percentage of Patients With a Positive Immune Response to Each of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine
Serotype 8-146 (8)
|
33.3 Percentage of patients
|
57.1 Percentage of patients
|
|
Percentage of Patients With a Positive Immune Response to Each of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine
Serotype 9-146 (9N)
|
22.2 Percentage of patients
|
60.7 Percentage of patients
|
|
Percentage of Patients With a Positive Immune Response to Each of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine
Serotype 14-146 (14)
|
30.2 Percentage of patients
|
60.7 Percentage of patients
|
|
Percentage of Patients With a Positive Immune Response to Each of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine
Serotype 19-146 (19F)
|
25.4 Percentage of patients
|
53.6 Percentage of patients
|
|
Percentage of Patients With a Positive Immune Response to Each of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine
Serotype 23-146 (23F)
|
20.6 Percentage of patients
|
35.7 Percentage of patients
|
SECONDARY outcome
Timeframe: Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group BPopulation: Immune response per-protocol population: Group A - All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B - All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.
The immune response to each of the 12 anti-pneumococcal antibody serotypes was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The pneumococcal antibody assay was a fluoroimmunoassay that used a Luminex Multiplex platform. Purified capsular polysaccharides isolated from 12 serotypes of S. pneumonia were covalently attached to microbeads and used as a capturing reagent. Phycoerythrin conjugated anti-human IgG was used for detection. A positive immune response against a serotype was defined as a 2-fold increase or an increase of \> 1 μg/mL from pre-vaccination levels.
Outcome measures
| Measure |
Rituximab + Methotrexate (Group A)
n=63 Participants
Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
Methotrexate (Group B)
n=28 Participants
Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
|---|---|---|
|
Percentage of Patients With a Positive Immune Response to at Least 50% (≥ 6 of 12) of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine
|
19.0 Percentage of patients
|
60.7 Percentage of patients
|
SECONDARY outcome
Timeframe: Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group BPopulation: Immune response per-protocol population: Group A - All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B - All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.
The immune response to each of the 12 anti-pneumococcal antibody serotypes was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The pneumococcal antibody assay was a fluoroimmunoassay that used a Luminex Multiplex platform. Purified capsular polysaccharides isolated from 12 serotypes of S. pneumonia were covalently attached to microbeads and used as a capturing reagent. Phycoerythrin conjugated anti-human IgG was used for detection. A positive immune response against a serotype was defined as a 2-fold increase or an increase of \> 1 μg/mL from pre-vaccination levels.
Outcome measures
| Measure |
Rituximab + Methotrexate (Group A)
n=63 Participants
Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
Methotrexate (Group B)
n=28 Participants
Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
|---|---|---|
|
Percentage of Patients With a Positive Immune Response to at Least k (for k = 1, 2, 3, 4, 5) of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine
1 serotype
|
57.1 Percentage of patients
|
82.1 Percentage of patients
|
|
Percentage of Patients With a Positive Immune Response to at Least k (for k = 1, 2, 3, 4, 5) of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine
2 serotypes
|
42.9 Percentage of patients
|
82.1 Percentage of patients
|
|
Percentage of Patients With a Positive Immune Response to at Least k (for k = 1, 2, 3, 4, 5) of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine
3 serotypes
|
38.1 Percentage of patients
|
78.6 Percentage of patients
|
|
Percentage of Patients With a Positive Immune Response to at Least k (for k = 1, 2, 3, 4, 5) of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine
4 serotypes
|
33.3 Percentage of patients
|
75.0 Percentage of patients
|
|
Percentage of Patients With a Positive Immune Response to at Least k (for k = 1, 2, 3, 4, 5) of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine
5 serotypes
|
23.8 Percentage of patients
|
67.9 Percentage of patients
|
SECONDARY outcome
Timeframe: Week 24 to Week 28 for Group A and Day 1 to Week 4 for Group BPopulation: Immune response per-protocol population: Group A - All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B - All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.
Anti-tetanus antibody was measured in serum samples immediately prior to and 4 weeks after administration of a tetanus toxoid adsorbed booster vaccine. The tetanus antibody test was an ELISA that used tetanus toxoid as a capturing reagent and alkaline phosphatase-conjugated anti-human IgG (γ) for detection.
Outcome measures
| Measure |
Rituximab + Methotrexate (Group A)
n=64 Participants
Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
Methotrexate (Group B)
n=26 Participants
Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
|---|---|---|
|
Serum Level of Anti-tetanus Antibody Measured Immediately Prior to and 4 Weeks After Administration of a Tetanus Toxoid Adsorbed Booster Vaccine
Pre-vaccination
|
1.2 IU/mL
Interval 0.88 to 1.69
|
1.0 IU/mL
Interval 0.49 to 2.14
|
|
Serum Level of Anti-tetanus Antibody Measured Immediately Prior to and 4 Weeks After Administration of a Tetanus Toxoid Adsorbed Booster Vaccine
4 weeks post-vaccination
|
4.0 IU/mL
Interval 2.72 to 5.74
|
5.2 IU/mL
Interval 2.25 to 12.0
|
SECONDARY outcome
Timeframe: Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group BPopulation: Immune response per-protocol population: Group A - All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B - All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.
Anti-pneumococcal antibody was measured immediately prior to and 4 weeks after administration of a 23-valent pneumococcal polysaccharide vaccine. The pneumococcal antibody assay was a fluoroimmunoassay that used a Luminex Multiplex platform. Purified capsular polysaccharides isolated from 12 serotypes of S. pneumonia were covalently attached to microbeads and used as a capturing reagent. Phycoerythrin conjugated anti-human IgG was used for detection.
Outcome measures
| Measure |
Rituximab + Methotrexate (Group A)
n=63 Participants
Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
Methotrexate (Group B)
n=28 Participants
Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
|---|---|---|
|
Serum Level of Anti-pneumococcal Antibody Measured Immediately Prior to and 4 Weeks After Administration of a 23-valent Pneumococcal Polysaccharide Vaccine
Pre-vaccination
|
0.8 µg/mL
Interval 0.64 to 1.06
|
1.0 µg/mL
Interval 0.68 to 1.47
|
|
Serum Level of Anti-pneumococcal Antibody Measured Immediately Prior to and 4 Weeks After Administration of a 23-valent Pneumococcal Polysaccharide Vaccine
4 weeks post-vaccination
|
1.0 µg/mL
Interval 0.76 to 1.37
|
2.3 µg/mL
Interval 1.39 to 3.89
|
SECONDARY outcome
Timeframe: Week 32 to Week 36 for Group A and Week 8 to Week 12 for Group BPopulation: Immune response per-protocol population: Group A - All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B - All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.
Anti-keyhole limpet hemocyanin antibody was measured immediately prior to and 4 weeks after the first administration of keyhole limpet hemocyanin. The keyhole limpet hemocyanin antibody ELISA assay used keyhole limpet hemocyanin as the plate coat and anti-human IgG-horseradish peroxidase for detection.
Outcome measures
| Measure |
Rituximab + Methotrexate (Group A)
n=64 Participants
Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
Methotrexate (Group B)
n=27 Participants
Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
|---|---|---|
|
Serum Level of Anti-keyhole Limpet Hemocyanin Antibody Measured Immediately Prior to and 4 Weeks After the First Administration of Keyhole Limpet Hemocyanin
Pre-vaccination
|
345.7 IU/mL
Interval 312.25 to 382.76
|
388.0 IU/mL
The confidence interval could not be calculated as only 1 patient had an anti-body response above the lower limit of quantitation.
|
|
Serum Level of Anti-keyhole Limpet Hemocyanin Antibody Measured Immediately Prior to and 4 Weeks After the First Administration of Keyhole Limpet Hemocyanin
4 weeks post-vaccination
|
539.5 IU/mL
Interval 461.54 to 630.61
|
1585.5 IU/mL
Interval 1065.15 to 2360.17
|
SECONDARY outcome
Timeframe: Day 1 to Week 24 for Group A and Day 1 to Week 12 for Group BPopulation: Skin test per-protocol population: Group A - All patients randomized to Group A who received any rituximab infusion, had Day 1 and Week 24 skin tests, and who provided complete diameter of induration readings. Group B - All patients randomized to Group B who had Day 1 and Week 12 skin tests and who provided complete diameter of induration readings.
Patients received an intradermal injection of C. albicans on the volar surface of the forearm on Day 1 and Week 24 for Group A or on Day 1 and Week 12 for Group B. Forty-eight to 72 hours after injection, patients were evaluated for a delayed-type hypersensitivity response by measuring the diameter of induration (palpable raised, hardened area of the forearm skin). A positive response to the C. albicans skin test was defined as at least 5 mm in diameter of induration.
Outcome measures
| Measure |
Rituximab + Methotrexate (Group A)
n=64 Participants
Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
Methotrexate (Group B)
n=28 Participants
Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
|---|---|---|
|
Percentage of Patients Who Maintained a Positive Response to the C. Albicans Skin Test From Day 1 to Week 24 for Group A or From Day 1 to Week 12 for Group B
|
77.4 Percentage of patients
|
70.0 Percentage of patients
|
SECONDARY outcome
Timeframe: Week 24Population: Safety population: All patients who received any amount of rituximab or any vaccine. Since only limited efficacy data were collected in this study, the parameters necessary to calculate the ACR20/50/70 responses were only available for patients in Group A.
Improvement must be seen in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line "no disease activity" \[symptom-free and no arthritis symptoms\] and the extreme right end "maximum disease activity"; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line "no pain" and the extreme right end "unbearable pain"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.
Outcome measures
| Measure |
Rituximab + Methotrexate (Group A)
n=66 Participants
Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
Methotrexate (Group B)
Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
|---|---|---|
|
Percentage of Patients in Group A With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24
ACR 20%
|
36.4 Percentage of patients
|
—
|
|
Percentage of Patients in Group A With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24
ACR 50%
|
21.2 Percentage of patients
|
—
|
|
Percentage of Patients in Group A With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24
ACR 70%
|
4.5 Percentage of patients
|
—
|
Adverse Events
Rituximab + Methotrexate (Group A) - Treatment Period
Serious events: 3 serious events
Other events: 51 other events
Deaths: 0 deaths
Methotrexate (Group B) - Treatment Period
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Group A - Optional Extension Re-treatment Period
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Group B - Optional Extension Re-treatment Period
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Group A - Safety Follow-up Period
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Group B - Safety Follow-up Period
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rituximab + Methotrexate (Group A) - Treatment Period
n=68 participants at risk
Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
Methotrexate (Group B) - Treatment Period
n=32 participants at risk
Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
Group A - Optional Extension Re-treatment Period
n=52 participants at risk
Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab.
|
Group B - Optional Extension Re-treatment Period
n=26 participants at risk
Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab.
|
Group A - Safety Follow-up Period
n=68 participants at risk
Patients received no treatment during the Safety Follow-up Period.
|
Group B - Safety Follow-up Period
n=32 participants at risk
Patients received no treatment during the Safety Follow-up Period.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
1.5%
1/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
General disorders
Chest pain
|
1.5%
1/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Infections and infestations
Hip fracture
|
1.5%
1/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
3.1%
1/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
3.1%
1/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Eye disorders
Amaurosis fugax
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
1.9%
1/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
1.9%
1/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
1.5%
1/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
3.8%
1/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
3.8%
1/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
3.1%
1/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
1.5%
1/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
1.5%
1/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
Other adverse events
| Measure |
Rituximab + Methotrexate (Group A) - Treatment Period
n=68 participants at risk
Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
Methotrexate (Group B) - Treatment Period
n=32 participants at risk
Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
|
Group A - Optional Extension Re-treatment Period
n=52 participants at risk
Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab.
|
Group B - Optional Extension Re-treatment Period
n=26 participants at risk
Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab.
|
Group A - Safety Follow-up Period
n=68 participants at risk
Patients received no treatment during the Safety Follow-up Period.
|
Group B - Safety Follow-up Period
n=32 participants at risk
Patients received no treatment during the Safety Follow-up Period.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
10.3%
7/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
3.1%
1/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.4%
5/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
3.1%
1/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.3%
7/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
6.2%
2/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
1.9%
1/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
15.4%
4/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
11.8%
8/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
18.8%
6/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Infections and infestations
Sinusitis
|
7.4%
5/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
3.8%
2/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
11.5%
3/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
10.3%
7/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
6.2%
2/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Infections and infestations
Influenza
|
7.4%
5/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
3.1%
1/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
17.6%
12/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
7.7%
2/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
2.9%
2/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
9.4%
3/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
8/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
3.1%
1/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
3.8%
2/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
7.7%
2/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.9%
4/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
3.1%
1/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Nervous system disorders
Headache
|
13.2%
9/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
9.4%
3/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Psychiatric disorders
Insomnia
|
4.4%
3/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
6.2%
2/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
7.4%
5/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
6.2%
2/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.4%
5/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
3.1%
1/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.3%
7/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
3.1%
1/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
11.5%
3/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
3.8%
2/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
7.7%
2/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
8.8%
6/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
4.4%
3/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
9.4%
3/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Ear and labyrinth disorders
Ear pruritus
|
1.5%
1/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
9.4%
3/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
General disorders
Fatigue
|
5.9%
4/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
7.7%
2/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
General disorders
Feeling hot
|
2.9%
2/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
6.2%
2/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
General disorders
Oedema peripheral
|
5.9%
4/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
7.7%
2/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
1.5%
1/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
6.2%
2/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
5.9%
4/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
7.7%
2/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Nervous system disorders
Dizziness
|
5.9%
4/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
11.5%
3/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
7.7%
2/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.2%
9/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
9.4%
3/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.9%
4/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
6.2%
2/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.4%
5/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
3.1%
1/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
1.5%
1/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
9.4%
3/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
|
Vascular disorders
Flushing
|
5.9%
4/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/52 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/26 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/68 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
0.00%
0/32 • Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks).
Safety population: All patients who received any amount of rituximab or any vaccine.
|
Additional Information
Medical Communications
Genentech, Inc.
Phone: 800 821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER