Trial Outcomes & Findings for A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis. (NCT NCT00502996)
NCT ID: NCT00502996
Last Updated: 2016-10-14
Results Overview
An Adverse event (AE) was considered any unfavorable medical event in a participant of clinical research who received the study drug and that not necessarily had a causal relationship with this treatment. An AE could, therefore, being any unfavorable sign and non-intentional, symptom or disease temporarily related with the use of a medicinal product, considered or not related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AEs. A serious adverse event (SAE) is any experience that suggested a significant risk, contraindication, caution, and at any dose fulfills at least one of the following criteria: adverse event considered as fatal (resulting in death), life threatening, defect of birth/congenital abnormality, required hospitalization or extension of hospital length of stay, significant medical intervention, resulted in significant disability/impairment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
246 participants
Primary outcome timeframe
Up to Week 48
Results posted on
2016-10-14
Participant Flow
A total of 246 participants were enrolled in study conducted from 20 February 2006 to 05 December 2008 across 56 study centers in 10 Latin American countries.
Out of 246 participants, fourteen did not receive study drug and were not included in analysis population.
Participant milestones
| Measure |
Rituximab
Eligible participants receiving Rituximab (MabThera/Rituxan) 1 gram/dose (g/dose) intravenously (IV) on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 milligram (mg) IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg per oris (PO) weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
|
|---|---|
|
Overall Study
STARTED
|
232
|
|
Overall Study
COMPLETED
|
188
|
|
Overall Study
NOT COMPLETED
|
44
|
Reasons for withdrawal
| Measure |
Rituximab
Eligible participants receiving Rituximab (MabThera/Rituxan) 1 gram/dose (g/dose) intravenously (IV) on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 milligram (mg) IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg per oris (PO) weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Treatment failure
|
25
|
|
Overall Study
Withdrawal Informed Consent
|
6
|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.
Baseline characteristics by cohort
| Measure |
Rituximab
n=232 Participants
Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
|
|---|---|
|
Age, Continuous
|
48.6 years
STANDARD_DEVIATION 12.2 • n=99 Participants
|
|
Sex: Female, Male
Female
|
207 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to Week 48Population: The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
An Adverse event (AE) was considered any unfavorable medical event in a participant of clinical research who received the study drug and that not necessarily had a causal relationship with this treatment. An AE could, therefore, being any unfavorable sign and non-intentional, symptom or disease temporarily related with the use of a medicinal product, considered or not related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AEs. A serious adverse event (SAE) is any experience that suggested a significant risk, contraindication, caution, and at any dose fulfills at least one of the following criteria: adverse event considered as fatal (resulting in death), life threatening, defect of birth/congenital abnormality, required hospitalization or extension of hospital length of stay, significant medical intervention, resulted in significant disability/impairment.
Outcome measures
| Measure |
Rituximab
n=232 Participants
Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
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|---|---|
|
Number of Participants With Any Adverse Event, Any Serious Adverse Event, and Death
Any AE
|
189 participants
|
|
Number of Participants With Any Adverse Event, Any Serious Adverse Event, and Death
Any SAE
|
12 participants
|
|
Number of Participants With Any Adverse Event, Any Serious Adverse Event, and Death
Death
|
0 participants
|
PRIMARY outcome
Timeframe: Up to Week 48Population: The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
An AE is any unfavorable sign and non-intentional, symptom or disease temporarily related with the use of a medicinal product, considered or not related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AEs. The Intensity of AEs was classified as Grade 1, Grade 2, Grade 3 and Grade 4. Grade 1: Discomfort was noticed, but the normal daily activity was not interrupted. Grade 2: Discomfort was enough to reduce the normal daily activity. Grade 3: There was disability for work or develop normal daily activities. Grade 4: It represented an immediate threat to life (these events were reported as SAEs).
Outcome measures
| Measure |
Rituximab
n=232 Participants
Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
|
|---|---|
|
Number of Participants With AEs According to Degree of Intensity
Grade 1 AEs
|
170 participants
|
|
Number of Participants With AEs According to Degree of Intensity
Grade 2 AEs
|
102 participants
|
|
Number of Participants With AEs According to Degree of Intensity
Grade 3 AEs
|
30 participants
|
|
Number of Participants With AEs According to Degree of Intensity
Grade 4 AEs
|
12 participants
|
PRIMARY outcome
Timeframe: Up to Week 48Population: The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
An AE is any unfavorable sign and non-intentional, symptom or disease temporarily related with the use of a medicinal product, considered or not related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AEs. A SAE is any experience that suggested a significant risk, contraindication, caution, and at any dose, fulfills, at least, one of the following criteria: adverse event considered as fatal (resulting in death), life threatening, defect of birth/congenital abnormality, required hospitalization or extension of hospital length of stay, significant medical intervention, resulted in significant disability/impairment. Relationship between AEs and medication under investigation was evaluated through the classification "Yes" and "No". A relationship classified as "Yes" implied a significant causal relationship with the medication under investigation which was evaluated based on enough evidences, facts or arguments.
Outcome measures
| Measure |
Rituximab
n=232 Participants
Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
|
|---|---|
|
Number of Participants With AEs Leading to Discontinuation and Any Drug Related AEs and SAEs
Any drug related AE
|
97 participants
|
|
Number of Participants With AEs Leading to Discontinuation and Any Drug Related AEs and SAEs
Any drug related SAE
|
0 participants
|
|
Number of Participants With AEs Leading to Discontinuation and Any Drug Related AEs and SAEs
Any AE leading to discontinuation
|
2 participants
|
PRIMARY outcome
Timeframe: Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48)Population: The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
Adverse event of special interest during the study treatment and follow up period included infections. The participants with AEs of special interest were reported at Screening, End of treatment (EOT), and End of Follow-up (EOFU) visit.
Outcome measures
| Measure |
Rituximab
n=232 Participants
Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
|
|---|---|
|
Number of Participants With AEs of Special Interest During the Study
Screening
|
5 participants
|
|
Number of Participants With AEs of Special Interest During the Study
EOT
|
12 participants
|
|
Number of Participants With AEs of Special Interest During the Study
EOFU
|
12 participants
|
SECONDARY outcome
Timeframe: Screening (Days -28 to 0) and EOT (Week 24)Population: The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
The values of hemoglobin (Hb) and mean corpuscular hemoglobin concentration (MCHC) for each participant were estimated at Screening and at EOT visit.
Outcome measures
| Measure |
Rituximab
n=191 Participants
Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
|
|---|---|
|
Mean Values of Hematology Parameters at Screening and EOT Visit (Hemoglobin and Mean Corpuscular Hemoglobin Concentration)
Hb, Screening
|
12.4 g/deciliter (dL)
Standard Deviation 1.9
|
|
Mean Values of Hematology Parameters at Screening and EOT Visit (Hemoglobin and Mean Corpuscular Hemoglobin Concentration)
Hb, EOT
|
12.8 g/deciliter (dL)
Standard Deviation 1.6
|
|
Mean Values of Hematology Parameters at Screening and EOT Visit (Hemoglobin and Mean Corpuscular Hemoglobin Concentration)
MCHC, Screening
|
30.0 g/deciliter (dL)
Standard Deviation 3.6
|
|
Mean Values of Hematology Parameters at Screening and EOT Visit (Hemoglobin and Mean Corpuscular Hemoglobin Concentration)
MCHC, EOT
|
30.9 g/deciliter (dL)
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Screening (Days -28 to 0) and EOT (Week 24)Population: The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
The hematology parameters (hematocrit, neutrophils, lymphocytes, monocytes, eosinophils, and basophils) for each participant were estimated at Screening and at EOT.
Outcome measures
| Measure |
Rituximab
n=191 Participants
Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
|
|---|---|
|
Mean Values of Hematology Parameters at Screening and EOT Visit (Hematocrit, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils)
Hematocrit, Screening
|
37.8 percentage of cells
Standard Deviation 4.2
|
|
Mean Values of Hematology Parameters at Screening and EOT Visit (Hematocrit, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils)
Hematocrit, EOT
|
38.9 percentage of cells
Standard Deviation 4.3
|
|
Mean Values of Hematology Parameters at Screening and EOT Visit (Hematocrit, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils)
Neutrophils, Screening
|
67.8 percentage of cells
Standard Deviation 9.4
|
|
Mean Values of Hematology Parameters at Screening and EOT Visit (Hematocrit, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils)
Neutrophils, EOT
|
65.1 percentage of cells
Standard Deviation 9.9
|
|
Mean Values of Hematology Parameters at Screening and EOT Visit (Hematocrit, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils)
Lymphocytes, Screening
|
24.0 percentage of cells
Standard Deviation 7.7
|
|
Mean Values of Hematology Parameters at Screening and EOT Visit (Hematocrit, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils)
Lymphocytes, EOT
|
25.6 percentage of cells
Standard Deviation 8.7
|
|
Mean Values of Hematology Parameters at Screening and EOT Visit (Hematocrit, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils)
Monocytes, Screening
|
4.3 percentage of cells
Standard Deviation 3.1
|
|
Mean Values of Hematology Parameters at Screening and EOT Visit (Hematocrit, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils)
Monocytes, EOT
|
5.4 percentage of cells
Standard Deviation 3.6
|
|
Mean Values of Hematology Parameters at Screening and EOT Visit (Hematocrit, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils)
Eosinophils, Screening
|
1.9 percentage of cells
Standard Deviation 2.0
|
|
Mean Values of Hematology Parameters at Screening and EOT Visit (Hematocrit, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils)
Eosinophils, EOT
|
2.5 percentage of cells
Standard Deviation 2.0
|
|
Mean Values of Hematology Parameters at Screening and EOT Visit (Hematocrit, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils)
Basophils, Screening
|
0.2 percentage of cells
Standard Deviation 0.3
|
|
Mean Values of Hematology Parameters at Screening and EOT Visit (Hematocrit, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils)
Basophils, EOT
|
0.3 percentage of cells
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Screening (Days -28 to 0) and EOT (Week 24)Population: The analysis was performed on safety population. Eligible participants who received one treatment dose of Rituximab, have completed the follow-up period, Visit 11, and end of follow-up period in safety conditions and also who had been withdrawn or not from the study were included in the safety population.
Mean corpuscular volume (MCV) is the average volume of red cells. The mean MCV concentration for each participant was estimated at Screening and EOT.
Outcome measures
| Measure |
Rituximab
n=191 Participants
Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
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|---|---|
|
Mean Values of Hematology Parameter at Screening and EOT Visit (Mean Corpuscular Volume)
MCV, Screening
|
85.8 femtoliters
Standard Deviation 8.5
|
|
Mean Values of Hematology Parameter at Screening and EOT Visit (Mean Corpuscular Volume)
MCV, EOT
|
87.7 femtoliters
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Screening (Days -28 to 0) and EOT (Week 24)Population: The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
The mean erythrocyte concentration for each participant was estimated at Screening and at EOT.
Outcome measures
| Measure |
Rituximab
n=191 Participants
Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
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|---|---|
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Mean Values of Hematology Parameter at Screening and EOT Visit (Erythrocytes)
Erythrocytes, Screening
|
4.5 10^12 cells/liter
Standard Deviation 1.2
|
|
Mean Values of Hematology Parameter at Screening and EOT Visit (Erythrocytes)
Erythrocytes, EOT
|
4.4 10^12 cells/liter
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Screening (Days -28 to 0) and EOT (Week 24)Population: The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
The mean leucocytes and platelets concentration for each participant was estimated at Screening, at EOT visit.
Outcome measures
| Measure |
Rituximab
n=191 Participants
Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
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|---|---|
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Mean Values of Hematology Parameters at Screening and EOT Visit (Leucocytes and Platelets)
Leucocytes, Screening
|
8.6 10^9 cells/liter
Standard Deviation 2.6
|
|
Mean Values of Hematology Parameters at Screening and EOT Visit (Leucocytes and Platelets)
Leucocytes, EOT
|
7.7 10^9 cells/liter
Standard Deviation 2.3
|
|
Mean Values of Hematology Parameters at Screening and EOT Visit (Leucocytes and Platelets)
Platelets, Screening
|
351.6 10^9 cells/liter
Standard Deviation 112.5
|
|
Mean Values of Hematology Parameters at Screening and EOT Visit (Leucocytes and Platelets)
Platelets, EOT
|
310.6 10^9 cells/liter
Standard Deviation 97.1
|
SECONDARY outcome
Timeframe: Screening (Days -28 to 0) and EOT (Week 24)Population: The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
The mean albumin and glucose concentration for each participant was estimated at Screening and at EOT visit.
Outcome measures
| Measure |
Rituximab
n=191 Participants
Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
|
|---|---|
|
Mean Values of Biochemistry Parameters at Screening and Visit 8 (Albumin and Glucose)
Albumin, Screening
|
3.9 g/dL
Standard Deviation 0.5
|
|
Mean Values of Biochemistry Parameters at Screening and Visit 8 (Albumin and Glucose)
Albumin, EOT
|
4.1 g/dL
Standard Deviation 0.4
|
|
Mean Values of Biochemistry Parameters at Screening and Visit 8 (Albumin and Glucose)
Glucose, Screening
|
86.1 g/dL
Standard Deviation 12.3
|
|
Mean Values of Biochemistry Parameters at Screening and Visit 8 (Albumin and Glucose)
Glucose, EOT
|
88.1 g/dL
Standard Deviation 26.5
|
SECONDARY outcome
Timeframe: Screening (Days -28 to 0) and EOT (Week 24)Population: The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
The mean concentration of cholesterol, uric acid, urea, creatinine, calcium, total bilirubin and serum total proteins (STP) for each participant was estimated at Screening and at EOT visit.
Outcome measures
| Measure |
Rituximab
n=191 Participants
Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
|
|---|---|
|
Mean Values of Cholesterol, Uric Acid, Urea, Creatinine, Calcium, Total Bilirubin and Serum Total Proteins at Screening and EOT Visit.
Cholesterol, Screening
|
187.9 mg/dL
Standard Deviation 42.2
|
|
Mean Values of Cholesterol, Uric Acid, Urea, Creatinine, Calcium, Total Bilirubin and Serum Total Proteins at Screening and EOT Visit.
Cholesterol, EOT
|
196.6 mg/dL
Standard Deviation 42.7
|
|
Mean Values of Cholesterol, Uric Acid, Urea, Creatinine, Calcium, Total Bilirubin and Serum Total Proteins at Screening and EOT Visit.
Uric acid, Screening
|
4.0 mg/dL
Standard Deviation 1.2
|
|
Mean Values of Cholesterol, Uric Acid, Urea, Creatinine, Calcium, Total Bilirubin and Serum Total Proteins at Screening and EOT Visit.
Uric acid, EOT
|
4.0 mg/dL
Standard Deviation 1.1
|
|
Mean Values of Cholesterol, Uric Acid, Urea, Creatinine, Calcium, Total Bilirubin and Serum Total Proteins at Screening and EOT Visit.
Urea, Screening
|
29.3 mg/dL
Standard Deviation 10.0
|
|
Mean Values of Cholesterol, Uric Acid, Urea, Creatinine, Calcium, Total Bilirubin and Serum Total Proteins at Screening and EOT Visit.
Urea, EOT
|
30.2 mg/dL
Standard Deviation 11.0
|
|
Mean Values of Cholesterol, Uric Acid, Urea, Creatinine, Calcium, Total Bilirubin and Serum Total Proteins at Screening and EOT Visit.
Creatinine, Screening
|
0.7 mg/dL
Standard Deviation 0.2
|
|
Mean Values of Cholesterol, Uric Acid, Urea, Creatinine, Calcium, Total Bilirubin and Serum Total Proteins at Screening and EOT Visit.
Creatinine, EOT
|
0.7 mg/dL
Standard Deviation 0.2
|
|
Mean Values of Cholesterol, Uric Acid, Urea, Creatinine, Calcium, Total Bilirubin and Serum Total Proteins at Screening and EOT Visit.
Calcium, Screening
|
9.0 mg/dL
Standard Deviation 1.3
|
|
Mean Values of Cholesterol, Uric Acid, Urea, Creatinine, Calcium, Total Bilirubin and Serum Total Proteins at Screening and EOT Visit.
Calcium, EOT
|
9.0 mg/dL
Standard Deviation 1.0
|
|
Mean Values of Cholesterol, Uric Acid, Urea, Creatinine, Calcium, Total Bilirubin and Serum Total Proteins at Screening and EOT Visit.
Total Bilirubin, Screening
|
0.7 mg/dL
Standard Deviation 1.1
|
|
Mean Values of Cholesterol, Uric Acid, Urea, Creatinine, Calcium, Total Bilirubin and Serum Total Proteins at Screening and EOT Visit.
Total Bilirubin, EOT
|
0.7 mg/dL
Standard Deviation 1.1
|
|
Mean Values of Cholesterol, Uric Acid, Urea, Creatinine, Calcium, Total Bilirubin and Serum Total Proteins at Screening and EOT Visit.
STP, Screening
|
7.3 mg/dL
Standard Deviation 0.6
|
|
Mean Values of Cholesterol, Uric Acid, Urea, Creatinine, Calcium, Total Bilirubin and Serum Total Proteins at Screening and EOT Visit.
STP, EOT
|
7.1 mg/dL
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Screening (Days -28 to 0) and EOT (Week 24)Population: The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
The mean concentration of potassium, chlorine, sodium and phosphorus for each participant was estimated at Screening and at EOT.
Outcome measures
| Measure |
Rituximab
n=191 Participants
Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
|
|---|---|
|
Mean Values of Potassium, Chlorine, Sodium, and Phosphorus at Screening and EOT Visit
Sodium, Screening
|
140.1 millimoles per liter
Standard Deviation 3.3
|
|
Mean Values of Potassium, Chlorine, Sodium, and Phosphorus at Screening and EOT Visit
Sodium, EOT
|
140.4 millimoles per liter
Standard Deviation 3.3
|
|
Mean Values of Potassium, Chlorine, Sodium, and Phosphorus at Screening and EOT Visit
Potassium, Screening
|
4.2 millimoles per liter
Standard Deviation 0.4
|
|
Mean Values of Potassium, Chlorine, Sodium, and Phosphorus at Screening and EOT Visit
Potassium, EOT
|
4.2 millimoles per liter
Standard Deviation 0.4
|
|
Mean Values of Potassium, Chlorine, Sodium, and Phosphorus at Screening and EOT Visit
Chlorine, Screening
|
103.1 millimoles per liter
Standard Deviation 4.2
|
|
Mean Values of Potassium, Chlorine, Sodium, and Phosphorus at Screening and EOT Visit
Chlorine, EOT
|
103.3 millimoles per liter
Standard Deviation 4.2
|
|
Mean Values of Potassium, Chlorine, Sodium, and Phosphorus at Screening and EOT Visit
Phosphorus, Screening
|
3.7 millimoles per liter
Standard Deviation 0.6
|
|
Mean Values of Potassium, Chlorine, Sodium, and Phosphorus at Screening and EOT Visit
Phosphorus, EOT
|
3.8 millimoles per liter
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Screening (Days -28 to 0) and EOT (Week 24)Population: The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
The mean aspartate transaminase (AST) and alanine transaminase (ALT), Alkaline phosphatase (AP), and Lactic dehydrogenase (LDH) concentration for each participant was estimated at Screening and at EOT visit.
Outcome measures
| Measure |
Rituximab
n=191 Participants
Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
|
|---|---|
|
Mean Values of Aspartate Transaminase, Alanine Transaminase, Alkaline Phosphatase, and Lactic Dehydrogenase at Screening and EOT Visit
AST, Screening
|
21.6 International units/liter
Standard Deviation 9.7
|
|
Mean Values of Aspartate Transaminase, Alanine Transaminase, Alkaline Phosphatase, and Lactic Dehydrogenase at Screening and EOT Visit
AST, EOT
|
22.0 International units/liter
Standard Deviation 9.5
|
|
Mean Values of Aspartate Transaminase, Alanine Transaminase, Alkaline Phosphatase, and Lactic Dehydrogenase at Screening and EOT Visit
ALT, Screening
|
24.1 International units/liter
Standard Deviation 14.9
|
|
Mean Values of Aspartate Transaminase, Alanine Transaminase, Alkaline Phosphatase, and Lactic Dehydrogenase at Screening and EOT Visit
ALT, EOT
|
25.9 International units/liter
Standard Deviation 14.9
|
|
Mean Values of Aspartate Transaminase, Alanine Transaminase, Alkaline Phosphatase, and Lactic Dehydrogenase at Screening and EOT Visit
AP, Screening
|
137.7 International units/liter
Standard Deviation 71.6
|
|
Mean Values of Aspartate Transaminase, Alanine Transaminase, Alkaline Phosphatase, and Lactic Dehydrogenase at Screening and EOT Visit
AP, EOT
|
138.2 International units/liter
Standard Deviation 81.7
|
|
Mean Values of Aspartate Transaminase, Alanine Transaminase, Alkaline Phosphatase, and Lactic Dehydrogenase at Screening and EOT Visit
LDH, Screening
|
311.0 International units/liter
Standard Deviation 149.1
|
|
Mean Values of Aspartate Transaminase, Alanine Transaminase, Alkaline Phosphatase, and Lactic Dehydrogenase at Screening and EOT Visit
LDH, EOT
|
300.5 International units/liter
Standard Deviation 125.4
|
SECONDARY outcome
Timeframe: Screening ((Days -28 to 0), EOT (Week 24), and EOFU (Week 48)Population: All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.
The efficacy of rituximab was assessed by evaluating mean duration of morning joint stiffness.
Outcome measures
| Measure |
Rituximab
n=232 Participants
Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
|
|---|---|
|
Mean Duration of Morning Joint Stiffness
Screening
|
120.1 Minutes
Standard Deviation 96.3
|
|
Mean Duration of Morning Joint Stiffness
EOT
|
16.0 Minutes
Standard Deviation 36.5
|
|
Mean Duration of Morning Joint Stiffness
EOFU
|
19.9 Minutes
Standard Deviation 42.4
|
SECONDARY outcome
Timeframe: Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48)Population: All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.
The efficacy of rituximab was assessed by evaluating painful joints.
Outcome measures
| Measure |
Rituximab
n=232 Participants
Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
|
|---|---|
|
Mean Value of Painful Joints
Painful joints, EOFU
|
4.4 number of painful joints
Standard Deviation 5.7
|
|
Mean Value of Painful Joints
Painful joints, Screening
|
17.5 number of painful joints
Standard Deviation 8.6
|
|
Mean Value of Painful Joints
Painful joints, EOT
|
3.8 number of painful joints
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Week 1, Week 12, and Week 24Population: All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.
American College of Rheumatology (ACR) criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) reduction in tender joints and swollen joints, as well as for three of the additional five ACR core set variables: patient's assessment of pain using a Visual Analog Scale (VAS) with left end of the line 0=no pain to right end of the line 100=unbearable pain); patient's global assessment of disease activity and physician's global assessment of disease activity using a VAS (0=no disease activity to 100=maximum disease activity); health assessment questionnaire (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant; C-reactive protein and globular sedimentation velocity.
Outcome measures
| Measure |
Rituximab
n=232 Participants
Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
|
|---|---|
|
Number of Participants With American College of Rheumatology (20, 50, and 70) Criteria
ACR 20, Week 1
|
1 participants
|
|
Number of Participants With American College of Rheumatology (20, 50, and 70) Criteria
ACR 20, Week 12
|
84 participants
|
|
Number of Participants With American College of Rheumatology (20, 50, and 70) Criteria
ACR 20, Week 24
|
88 participants
|
|
Number of Participants With American College of Rheumatology (20, 50, and 70) Criteria
ACR 50, Week 1
|
0 participants
|
|
Number of Participants With American College of Rheumatology (20, 50, and 70) Criteria
ACR 50, Week 12
|
50 participants
|
|
Number of Participants With American College of Rheumatology (20, 50, and 70) Criteria
ACR 50, Week 24
|
62 participants
|
|
Number of Participants With American College of Rheumatology (20, 50, and 70) Criteria
ACR 70, Week 1
|
0 participants
|
|
Number of Participants With American College of Rheumatology (20, 50, and 70) Criteria
ACR 70, Week 12
|
33 participants
|
|
Number of Participants With American College of Rheumatology (20, 50, and 70) Criteria
ACR 70, Week 24
|
42 participants
|
SECONDARY outcome
Timeframe: Screening (Days -28 to 0), Week 1, Week 12, and Week 24Population: All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.
Health Assessment Questionnaire - Disease Index (HAQ-DI) indicates how the disease affected participant's activities of daily life. It consisted of 20 questions in 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale, 0=without any difficulty to 3=unable to do. Sum of scores was divided by number of domains with a score for a total possible score of 0 (best/no difficulties to perform activities) to 3 (worst/ unable to perform activities at all).
Outcome measures
| Measure |
Rituximab
n=106 Participants
Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
|
|---|---|
|
Mean Value of Quality of Life (Health Assessment Questionnaire - Disease Index)
Screening; n = 106
|
2.6 Scores on scale
Standard Deviation 1.3
|
|
Mean Value of Quality of Life (Health Assessment Questionnaire - Disease Index)
Week 1; n = 114
|
2.5 Scores on scale
Standard Deviation 1.4
|
|
Mean Value of Quality of Life (Health Assessment Questionnaire - Disease Index)
Week 12; n = 107
|
1.25 Scores on scale
Standard Deviation 1.0
|
|
Mean Value of Quality of Life (Health Assessment Questionnaire - Disease Index)
Week 24; n = 105
|
1.0 Scores on scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Screening ((Days -28 to 0), EOT (Week 24), and EOFU (Week 48)Population: All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.
C Reactive Protein (CRP) is a component of ACR. CRP is a marker of inflammation.
Outcome measures
| Measure |
Rituximab
n=232 Participants
Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
|
|---|---|
|
Mean Values of C Reactive Protein
Week 1
|
27.6 milligrams per liter
Standard Deviation 56.1
|
|
Mean Values of C Reactive Protein
Week 12
|
13.6 milligrams per liter
Standard Deviation 25.0
|
|
Mean Values of C Reactive Protein
Screening
|
28.0 milligrams per liter
Standard Deviation 45.3
|
|
Mean Values of C Reactive Protein
Week 24
|
15.3 milligrams per liter
Standard Deviation 45.2
|
SECONDARY outcome
Timeframe: Screening ((Days -28 to 0), Week 1, Week 12, and Week 24Population: All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.
Globular sedimentation velocity is a component of ACR.
Outcome measures
| Measure |
Rituximab
n=232 Participants
Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
|
|---|---|
|
Mean Values of Globular Sedimentation Velocity
Screening
|
43.7 millimeters per hour
Standard Deviation 22.8
|
|
Mean Values of Globular Sedimentation Velocity
Week 1
|
41.1 millimeters per hour
Standard Deviation 23.0
|
|
Mean Values of Globular Sedimentation Velocity
Week 12
|
26.8 millimeters per hour
Standard Deviation 17.8
|
|
Mean Values of Globular Sedimentation Velocity
Week 24
|
24.6 millimeters per hour
Standard Deviation 19.0
|
SECONDARY outcome
Timeframe: Screening ((Days -28 to 0), Week 1, Week 12, and Week 24Population: All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.
Pain assessment was assessed by using a VAS (0=no pain to 100=unbearable pain). Disease activity was also evaluated by participants and investigators by using a VAS (0=no disease activity to 100=maximum disease activity).
Outcome measures
| Measure |
Rituximab
n=232 Participants
Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
|
|---|---|
|
Mean Values of Pain and Activity Based on Visual Analogue Scale
Activity (investigator), Week 1
|
6.3 Scores on scale
Standard Deviation 2.1
|
|
Mean Values of Pain and Activity Based on Visual Analogue Scale
Pain, Screening
|
6.9 Scores on scale
Standard Deviation 1.9
|
|
Mean Values of Pain and Activity Based on Visual Analogue Scale
Pain, Week 1
|
6.9 Scores on scale
Standard Deviation 1.9
|
|
Mean Values of Pain and Activity Based on Visual Analogue Scale
Pain, Week 12
|
3.6 Scores on scale
Standard Deviation 2.4
|
|
Mean Values of Pain and Activity Based on Visual Analogue Scale
Pain, Week 24
|
3.0 Scores on scale
Standard Deviation 2.2
|
|
Mean Values of Pain and Activity Based on Visual Analogue Scale
Activity (participant), Screening
|
6.6 Scores on scale
Standard Deviation 2.3
|
|
Mean Values of Pain and Activity Based on Visual Analogue Scale
Activity (participant), Week 1
|
5.9 Scores on scale
Standard Deviation 2.5
|
|
Mean Values of Pain and Activity Based on Visual Analogue Scale
Activity (participant), Week 12
|
4.7 Scores on scale
Standard Deviation 2.8
|
|
Mean Values of Pain and Activity Based on Visual Analogue Scale
Activity (participant), Week 24
|
3.9 Scores on scale
Standard Deviation 2.7
|
|
Mean Values of Pain and Activity Based on Visual Analogue Scale
Activity (investigator), Screening
|
6.4 Scores on scale
Standard Deviation 2.0
|
|
Mean Values of Pain and Activity Based on Visual Analogue Scale
Activity (investigator), Week 12
|
3.9 Scores on scale
Standard Deviation 3.9
|
|
Mean Values of Pain and Activity Based on Visual Analogue Scale
Activity (investigator), Week 24
|
3.0 Scores on scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48)Population: All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.
The efficacy of rituximab was assessed by evaluating inflamed joints.
Outcome measures
| Measure |
Rituximab
n=232 Participants
Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
|
|---|---|
|
Mean Value of Inflamed Joints
Inflamed joints, Screening
|
17.5 number of inflamed joints
Standard Deviation 8.6
|
|
Mean Value of Inflamed Joints
Inflamed joints, EOT
|
3.8 number of inflamed joints
Standard Deviation 4.9
|
|
Mean Value of Inflamed Joints
Inflamed joints, EOFU
|
4.4 number of inflamed joints
Standard Deviation 5.7
|
Adverse Events
Rituximab
Serious events: 12 serious events
Other events: 189 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rituximab
n=232 participants at risk
Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.43%
1/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Gastrointestinal disorders
Acute gastroenteritis
|
0.43%
1/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Reproductive system and breast disorders
Ovarian neoplasm NOS
|
0.43%
1/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Reproductive system and breast disorders
Uterine myoma
|
0.43%
1/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.43%
1/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.43%
1/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Infections and infestations
Tubo-ovarian abscess
|
0.43%
1/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis aggravated
|
0.43%
1/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Nervous system disorders
Cerebral infarction
|
0.43%
1/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Psychiatric disorders
Depression
|
0.43%
1/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Renal and urinary disorders
Acute kidney failure
|
0.43%
1/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Surgical and medical procedures
Baker's cyst excision
|
0.43%
1/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
Other adverse events
| Measure |
Rituximab
n=232 participants at risk
Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
9.5%
22/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Gastrointestinal disorders
Diarrhea
|
6.9%
16/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.5%
15/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Gastrointestinal disorders
Vomiting
|
3.9%
9/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Gastrointestinal disorders
Gastritis
|
3.9%
9/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Gastrointestinal disorders
Pyrosis
|
2.6%
6/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Gastrointestinal disorders
Epigastralgia
|
2.6%
6/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Gastrointestinal disorders
Constipation
|
2.6%
6/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
5/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Gastrointestinal disorders
Dry mouth
|
1.7%
4/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Gastrointestinal disorders
Epigastric burning
|
1.7%
4/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Gastrointestinal disorders
Colitis
|
1.3%
3/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Gastrointestinal disorders
Dry throat
|
1.3%
3/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Infections and infestations
Urinary tract infection
|
9.9%
23/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Infections and infestations
Upper respiratory tract infection viral NOS
|
6.0%
14/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Infections and infestations
Pharyngitis
|
3.9%
9/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Infections and infestations
Bronchitis
|
2.2%
5/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Infections and infestations
Tonsillitis
|
1.7%
4/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Infections and infestations
Tooth infection
|
1.3%
3/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Infections and infestations
Cellulitis
|
1.3%
3/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
6.5%
15/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.9%
9/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
3.0%
7/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract infection NOS
|
2.6%
6/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
2.6%
6/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dry cough
|
1.3%
3/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
1.3%
3/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.3%
3/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Nervous system disorders
Headache
|
17.2%
40/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Nervous system disorders
Dizziness
|
7.3%
17/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Nervous system disorders
Vertigo
|
1.3%
3/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.0%
7/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.0%
7/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Skin and subcutaneous tissue disorders
Accelerated hair loss
|
2.6%
6/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus NOS
|
2.6%
6/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.7%
4/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
1.7%
4/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer NOS
|
1.7%
4/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.3%
3/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Skin and subcutaneous tissue disorders
Itching
|
1.3%
3/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
3.4%
8/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis aggravated
|
3.0%
7/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
4/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Musculoskeletal and connective tissue disorders
Lumbago
|
1.3%
3/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.3%
3/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
General disorders
Shivers
|
3.9%
9/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
General disorders
Disease progression
|
2.6%
6/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
General disorders
Hyperthermia
|
2.6%
6/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
General disorders
Fatigue
|
1.3%
3/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Eye disorders
Conjunctivitis
|
2.6%
6/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Eye disorders
Xerophthalmia
|
1.7%
4/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Psychiatric disorders
Somnolence
|
3.0%
7/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Psychiatric disorders
Depression
|
2.2%
5/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Psychiatric disorders
Insomnia
|
2.2%
5/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Immune system disorders
Rheumatoid arthritis aggravated
|
2.2%
5/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Immune system disorders
Allergic conditions
|
1.3%
3/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Immune system disorders
Allergic rhinitis
|
1.3%
3/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.3%
3/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Metabolism and nutrition disorders
Osteoporosis
|
1.3%
3/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Vascular disorders
Hypertension arterial
|
5.2%
12/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Cardiac disorders
Dyspnea
|
2.6%
6/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Cardiac disorders
Arrhythmia
|
1.3%
3/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Renal and urinary disorders
Hematuria
|
1.7%
4/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
4/232 • Up to Week 48
Safety population was used for collecting data on adverse events. The safety population included all eligible participants who received one treatment dose of rituximab and, have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 61 6878333
Email: [email protected]
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