Trial Outcomes & Findings for A Study of MabThera (Rituximab) in Participants With Rheumatoid Arthritis Who Have Had an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARD) and/or Anti-Tumor Necrosis Factor (Anti-TNF) Therapy. (NCT NCT00503425)
NCT ID: NCT00503425
Last Updated: 2017-08-15
Results Overview
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs was exclusive of SAEs.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
215 participants
Primary outcome timeframe
Baseline up to study withdrawal or follow-up (Approximately 104 weeks)
Results posted on
2017-08-15
Participant Flow
Participant milestones
| Measure |
Rituximab
Participants received rituximab (MabThera) 1000 milligrams (mg) intravenous (IV) dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the European League Against Rheumatism (EULAR) response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
|
|---|---|
|
Overall Study
STARTED
|
215
|
|
Overall Study
COMPLETED
|
161
|
|
Overall Study
NOT COMPLETED
|
54
|
Reasons for withdrawal
| Measure |
Rituximab
Participants received rituximab (MabThera) 1000 milligrams (mg) intravenous (IV) dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the European League Against Rheumatism (EULAR) response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
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|---|---|
|
Overall Study
Participant files lost
|
6
|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Lack of Efficacy
|
25
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Death
|
3
|
|
Overall Study
Missing Data/Unknown
|
4
|
Baseline Characteristics
A Study of MabThera (Rituximab) in Participants With Rheumatoid Arthritis Who Have Had an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARD) and/or Anti-Tumor Necrosis Factor (Anti-TNF) Therapy.
Baseline characteristics by cohort
| Measure |
Rituximab
n=209 Participants
Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
|
|---|---|
|
Age, Continuous
|
56.6 Years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
146 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to study withdrawal or follow-up (Approximately 104 weeks)Population: Safety population included all participants who had received any part of an infusion of study medication.
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs was exclusive of SAEs.
Outcome measures
| Measure |
Rituximab
n=209 Participants
Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
|
|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
176 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
70 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: ITT Population. Here, number of participants analyzed (N) signified those participants who were evaluable for this outcome and "n" signified participants with evaluable data for a specified time point.
DAS28 score is a measure of participant's disease activity calculated using tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], participant's global assessment of disease activity (PGH) \[visual analog scale (VAS): 0=no disease activity to 100=maximum disease activity\] and erythrocyte sedimentation rate (ESR). DAS28 was calculated according to following formula: 0.56 multiplied by (\*) square root (√) of TJC\] plus (+) \[0.28\*√SJC\]+\[0.70\*the natural logarithm (ln) ESR\]+\[0.014\*PGH\]. Total possible score of 0 to approximately 10, where higher scores represented higher disease activity. Scores below 2.6 indicated clinical remission, score of less than or equals to (\</=) 3.2 indicated low disease activity, score of \</=5.1 indicated moderate disease activity, scores above 5.1 indicated high or severe disease. Rituximab was administered as needed during episodes of inflammation for up to 5 courses. Change from baseline in DAS28 to Week 24 was reported for all 5 courses.
Outcome measures
| Measure |
Rituximab
n=205 Participants
Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
|
|---|---|
|
Mean Change From Baseline in Disease Activity Score Based on 28 Joints (DAS 28) at Week 24
Baseline (n=205)
|
6.6 Units on a scale
Standard Deviation 1.0
|
|
Mean Change From Baseline in Disease Activity Score Based on 28 Joints (DAS 28) at Week 24
Change at Week 24: Course 1 (n=158)
|
-2.3 Units on a scale
Standard Deviation 1.6
|
|
Mean Change From Baseline in Disease Activity Score Based on 28 Joints (DAS 28) at Week 24
Change at Week 24: Course 2 (n=69)
|
-2.4 Units on a scale
Standard Deviation 1.3
|
|
Mean Change From Baseline in Disease Activity Score Based on 28 Joints (DAS 28) at Week 24
Change at Week 24: Course 3 (n=30)
|
-2.8 Units on a scale
Standard Deviation 1.4
|
|
Mean Change From Baseline in Disease Activity Score Based on 28 Joints (DAS 28) at Week 24
Change at Week 24: Course 4 (n=9)
|
-2.6 Units on a scale
Standard Deviation 1.1
|
|
Mean Change From Baseline in Disease Activity Score Based on 28 Joints (DAS 28) at Week 24
Change at Week 24: Course 5 (n=0)
|
NA Units on a scale
Standard Deviation NA
Data was not analyzed as no valid data was available at week 24.
|
SECONDARY outcome
Timeframe: Week 24Population: ITT Population. Here, number of participants analyzed (N) signified those participants who were evaluable for this outcome and "n" signified participants with evaluable data for a specified time point.
DAS28 score is a measure of participant's disease activity calculated using TJC28, SJC28, PGH \[VAS: 0=no disease activity to 100=maximum disease activity\] and ESR. DAS28 was calculated according to following formula: \[0.56\*√TJC\] + \[0.28\*√SJC\] + \[0.70\*ln ESR\] + \[0.014\*PGH\]. Total possible score of 0 to approximately 10, where higher scores represented higher disease activity. Scores below 2.6 indicated clinical remission, score of \</= 3.2 indicated low disease activity, score of \</= 5.1 indicated moderate disease activity, and scores above 5.1 indicated high or severe disease. Rituximab was administered as needed during episodes of inflammation for up to 5 courses. Change from baseline in DAS28 to Week 24 was reported for all 5 courses. Participants whose DAS28 score improved by 1.2 score were reported.
Outcome measures
| Measure |
Rituximab
n=158 Participants
Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
|
|---|---|
|
Percentage of Participants Whose DAS28 Improved by Greater Than (>) 1.2 at Week 24
Course 1 (n=158)
|
72.8 Percentage of participants
|
|
Percentage of Participants Whose DAS28 Improved by Greater Than (>) 1.2 at Week 24
Course 2 (n=69)
|
84.1 Percentage of participants
|
|
Percentage of Participants Whose DAS28 Improved by Greater Than (>) 1.2 at Week 24
Course 3 (n=30)
|
86.7 Percentage of participants
|
|
Percentage of Participants Whose DAS28 Improved by Greater Than (>) 1.2 at Week 24
Course 4 (n=9)
|
77.8 Percentage of participants
|
|
Percentage of Participants Whose DAS28 Improved by Greater Than (>) 1.2 at Week 24
Course 5 (n=0)
|
NA Percentage of participants
Data was not analyzed as no valid data was available at week 24.
|
SECONDARY outcome
Timeframe: Week 24Population: ITT Population. Here, number of participants analyzed (N) signified those participants who were evaluable for this outcome and "n" signified participants with evaluable data for a specified time point.
Clinical response was assessed according to EULAR categorical DAS28 response criteria, which defined clinically meaningful improvement at Week 24. EULAR response was based on change from baseline (COB) in DAS28 score and also on actual DAS28 score, at Week 24. DAS28 score= participant's disease activity calculated using TJC28, SJC28, PGH \[VAS: 0=no disease activity to 100=maximum disease activity\] and ESR. DAS28 was calculated by following formula: 0.56\*√TJC+(0.28\*√SJC)+(0.70\*ln ESR)+(0.014\*PGH). Total possible score=0-10, higher scores represented higher disease activity. Scores below 2.6: clinical remission, \</=3.2: low disease activity, \</=5.1: moderate disease activity, above 5.1: severe disease. EULAR Good response: DAS28\</=3.2; COB\<-1.2. Moderate response: DAS28\</=3.2 or \>3.2 to \</=5.1 or \>5.1; COB \<-1.2 or \<-0.6 to greater than or equal to (\>/=)-1.2. No response: DAS28 \</=3.2 or \> 3.2 to \</=5.1 or \>5.1; COB \<-0.6 to \>/=-1.2 or \>/=-0.6. EULAR response was reported for 5 courses.
Outcome measures
| Measure |
Rituximab
n=164 Participants
Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
|
|---|---|
|
Percentage of Participants With EULAR DAS 28 Response at Week 24
Course 2: Moderate Response (n=71)
|
76.1 Percentage of participants
|
|
Percentage of Participants With EULAR DAS 28 Response at Week 24
Course 1: Good Response (n=164)
|
12.8 Percentage of participants
|
|
Percentage of Participants With EULAR DAS 28 Response at Week 24
Course 1: Moderate Response (n=164)
|
65.9 Percentage of participants
|
|
Percentage of Participants With EULAR DAS 28 Response at Week 24
Course 1: No Response (n=164)
|
21.3 Percentage of participants
|
|
Percentage of Participants With EULAR DAS 28 Response at Week 24
Course 2: Good Response (n=71)
|
8.5 Percentage of participants
|
|
Percentage of Participants With EULAR DAS 28 Response at Week 24
Course 2: No Response (n=71)
|
15.5 Percentage of participants
|
|
Percentage of Participants With EULAR DAS 28 Response at Week 24
Course 3: Good Response (n=30)
|
13.3 Percentage of participants
|
|
Percentage of Participants With EULAR DAS 28 Response at Week 24
Course 3: Moderate Response (n=30)
|
76.7 Percentage of participants
|
|
Percentage of Participants With EULAR DAS 28 Response at Week 24
Course 3: No Response (n=30)
|
10.0 Percentage of participants
|
|
Percentage of Participants With EULAR DAS 28 Response at Week 24
Course 4: Good Response (n=9)
|
0.0 Percentage of participants
|
|
Percentage of Participants With EULAR DAS 28 Response at Week 24
Course 4: Moderate Response (n=9)
|
77.8 Percentage of participants
|
|
Percentage of Participants With EULAR DAS 28 Response at Week 24
Course 4: No Response (n=9)
|
22.2 Percentage of participants
|
|
Percentage of Participants With EULAR DAS 28 Response at Week 24
Course 5 (n=0)
|
NA Percentage of participants
Data was not analyzed as no valid data was available at week 24.
|
SECONDARY outcome
Timeframe: Baseline, Weeks 48 and 104 (End of treatment)Population: ITT population. Here, number of participants analyzed (N) signified those participants who were evaluable for this outcome and "n" signified participants with evaluable data for a specified time point.
Bone density or bone mineral density (BMD) is the amount of bone mineral in bone tissue. BMD test results are compared to the ideal or peak BMD of a healthy 30-year-old adult, and results are provided as T-score. A score of 0 means BMD is equal to the norm for a healthy young adult. Differences between observed BMD and that of the healthy young adult norm are measured in units called standard deviations (SDs). The more standard deviations below 0, indicated as negative numbers, lower the BMD higher the risk of fracture. SD + 1 to -1 indicates normal BMD; SD between -1 to -2.5 indicates low bone mass, SD -2.5 or lower indicates osteoporosis. Change in bone density was measured in participants who were not treated with biphosphonates by Dual Energy X-Ray Absorptiometry. Change in bone density was assessed at baseline and at Weeks 48 and 104. Change from baseline in bone density score was reported for all 5 courses.
Outcome measures
| Measure |
Rituximab
n=112 Participants
Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
|
|---|---|
|
Change From Baseline in Bone Density Score at Weeks 48 and 104
Change at Week 48: Course 4, Hip T-Score (n=0)
|
NA T-score
Standard Deviation NA
Data was not analyzed as no valid data was available for the specified time point.
|
|
Change From Baseline in Bone Density Score at Weeks 48 and 104
Change at Week 48: Course 4, Spine T-Score (n=0)
|
NA T-score
Standard Deviation NA
Data was not analyzed as no valid data was available for the specified time point.
|
|
Change From Baseline in Bone Density Score at Weeks 48 and 104
Change at Week 104: Course 4, Hip T-Score (n=0)
|
NA T-score
Standard Deviation NA
Data was not analyzed as no valid data was available for the specified time point.
|
|
Change From Baseline in Bone Density Score at Weeks 48 and 104
Change at Week 104: Course 4, Spine T-Score (n=0)
|
NA T-score
Standard Deviation NA
Data was not analyzed as no valid data was available for the specified time point.
|
|
Change From Baseline in Bone Density Score at Weeks 48 and 104
Change during Course 5 (n=0)
|
NA T-score
Standard Deviation NA
Data was not analyzed as no valid data was available for the specified time point.
|
|
Change From Baseline in Bone Density Score at Weeks 48 and 104
Baseline: Hip T-Score (n=112)
|
-1.08 T-score
Standard Deviation 1.19
|
|
Change From Baseline in Bone Density Score at Weeks 48 and 104
Baseline: Spine T-Score (n=109)
|
-1.13 T-score
Standard Deviation 1.26
|
|
Change From Baseline in Bone Density Score at Weeks 48 and 104
Change at Week 48: Course 1, Hip T-Score ( n=14)
|
0.09 T-score
Standard Deviation 0.43
|
|
Change From Baseline in Bone Density Score at Weeks 48 and 104
Change at Week 48: Course 1, Spine T-Score (n=14)
|
-0.03 T-score
Standard Deviation 0.46
|
|
Change From Baseline in Bone Density Score at Weeks 48 and 104
Change at Week 104: Course 1, Hip T-Score (n=11)
|
-0.51 T-score
Standard Deviation 1.60
|
|
Change From Baseline in Bone Density Score at Weeks 48 and 104
Change at Week 104: Course 1, Spine T-Score (n=11)
|
0.45 T-score
Standard Deviation 1.73
|
|
Change From Baseline in Bone Density Score at Weeks 48 and 104
Change at Week 48: Course 2, Hip T-Score (n=0)
|
NA T-score
Standard Deviation NA
Data was not analyzed as no valid data was available for the specified time point.
|
|
Change From Baseline in Bone Density Score at Weeks 48 and 104
Change at Week 48: Course 2, Spine T-Score (n=0)
|
NA T-score
Standard Deviation NA
Data was not analyzed as no valid data was available for the specified time point.
|
|
Change From Baseline in Bone Density Score at Weeks 48 and 104
Change at Week 104: Course 2, Hip T-Score (n=0)
|
NA T-score
Standard Deviation NA
Data was not analyzed as no valid data was available for the specified time point.
|
|
Change From Baseline in Bone Density Score at Weeks 48 and 104
Change at Week 104: Course 2, Spine T-Score (n=0)
|
NA T-score
Standard Deviation NA
Data was not analyzed as no valid data was available for the specified time point.
|
|
Change From Baseline in Bone Density Score at Weeks 48 and 104
Change at Week 48: Course 3, Hip T-Score (n=0)
|
NA T-score
Standard Deviation NA
Data was not analyzed as no valid data was available for the specified time point.
|
|
Change From Baseline in Bone Density Score at Weeks 48 and 104
Change at Week 48: Course 3, Spine T-Score (n=0)
|
NA T-score
Standard Deviation NA
Data was not analyzed as no valid data was available for the specified time point.
|
|
Change From Baseline in Bone Density Score at Weeks 48 and 104
Change at Week 104: Course 3, Hip T-Score (n=0)
|
NA T-score
Standard Deviation NA
Data was not analyzed as no valid data was available for the specified time point.
|
|
Change From Baseline in Bone Density Score at Weeks 48 and 104
Change at Week 104: Course 3, Spine T-Score (n=0)
|
NA T-score
Standard Deviation NA
Data was not analyzed as no valid data was available for the specified time point.
|
Adverse Events
Rituximab
Serious events: 70 serious events
Other events: 176 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rituximab
n=209 participants at risk
Participants received rituximab (Mabthera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Cardiac disorders
Myocardial infarction
|
0.96%
2/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Ear and labyrinth disorders
Vertigo
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Eye disorders
Cataract
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Eye disorders
Retinal detachment
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.96%
2/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Gastrointestinal disorders
Constipation
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Gastrointestinal disorders
Palatal disorder
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
General disorders
Chest pain
|
3.8%
8/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
General disorders
Oedema peripheral
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
General disorders
Pain
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
General disorders
Pyrexia
|
1.9%
4/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
General disorders
Sudden death
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.4%
3/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Immune system disorders
Drug hypersensitivity
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Infections and infestations
Abscess
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Infections and infestations
Bacterial sepsis
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Infections and infestations
Cellulitis
|
0.96%
2/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Infections and infestations
Gastroenteritis
|
0.96%
2/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Infections and infestations
Otitis externa
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Infections and infestations
Pneumonia
|
1.9%
4/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Infections and infestations
Pyelonephritis
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Infections and infestations
Respiratory tract infection
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.96%
2/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Infections and infestations
Urinary tract infection
|
0.96%
2/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.96%
2/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.96%
2/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.96%
2/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.96%
2/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Investigations
Endoscopy
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Investigations
Endoscopy upper gastrointestinal tract
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Investigations
Fibrin D dimer
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.96%
2/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
5.3%
11/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Nervous system disorders
Aphasia
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.96%
2/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Nervous system disorders
Hemiparesis
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Nervous system disorders
Hypoaesthesia
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Nervous system disorders
Presyncope
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Nervous system disorders
Radicular pain
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Nervous system disorders
Syncope
|
1.9%
4/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
1.9%
4/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Psychiatric disorders
Anxiety
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.96%
2/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.96%
2/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Surgical and medical procedures
Joint manipulation
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Surgical and medical procedures
Pain management
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Surgical and medical procedures
Polypectomy
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Surgical and medical procedures
Spinal laminectomy
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Vascular disorders
Deep vein thrombosis
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Vascular disorders
Raynaud's phenomenon
|
0.48%
1/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
Other adverse events
| Measure |
Rituximab
n=209 participants at risk
Participants received rituximab (Mabthera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
11/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
General disorders
Chest pain
|
6.7%
14/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
General disorders
Pyrexia
|
5.7%
12/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
21/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Infections and infestations
Urinary tract infection
|
7.2%
15/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
5.7%
12/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
10.5%
22/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
12/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.4%
28/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
12.0%
25/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Nervous system disorders
Headache
|
9.6%
20/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
14/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
|
Vascular disorders
Hypertension
|
8.6%
18/209 • Baseline up to study withdrawal or Follow-up (Approximately 104 weeks)
Safety population.
|
Additional Information
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