Trial Outcomes & Findings for A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis (NCT NCT01089023)

Last Updated: 2014-07-22

Results Overview

Percentage of participants with a serious adverse event (SAE), who died, with an adverse event (AE), or study drug related AE during the study.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

95 participants

Primary outcome timeframe

Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24

Results posted on

2014-07-22

Participant Flow

Participant milestones

Participant milestones
Measure	Tocilizumab 8 Milligrams Per Kilogram (mg/kg) Participants received tocilizumab 8 mg/kg intravenous (IV) infusion, once every 4 weeks for a total of 6 infusions.
Overall Study STARTED	95
Overall Study COMPLETED	88
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Tocilizumab 8 Milligrams Per Kilogram (mg/kg) Participants received tocilizumab 8 mg/kg intravenous (IV) infusion, once every 4 weeks for a total of 6 infusions.
Overall Study Lost to Follow-up	3
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	1
Overall Study Protocol Violation	1
Overall Study Lack of Efficacy	1

Baseline Characteristics

A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tocilizumab 8 mg/kg n=95 Participants Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
Age, Continuous	44.89 years STANDARD_DEVIATION 13.677 • n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24

Population: All the participants who were administered treatment at each visit were considered during the analysis.

Percentage of participants with a serious adverse event (SAE), who died, with an adverse event (AE), or study drug related AE during the study.

Outcome measures

Outcome measures
Measure	Tocilizumab 8 mg/kg n=95 Participants Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
Percentage of Participants Reporting Any Adverse Event - Overall Summary of Events With an SAE	8.4 percentage of participants
Percentage of Participants Reporting Any Adverse Event - Overall Summary of Events Who Died	0 percentage of participants
Percentage of Participants Reporting Any Adverse Event - Overall Summary of Events With any drug-related AE	38.9 percentage of participants
Percentage of Participants Reporting Any Adverse Event - Overall Summary of Events With any AE	45.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, and 24

Population: All the participants who were administered treatment at each visit were considered during the analysis. n (number) at Week 24 equals (=) number of participants in that visit; n at Other Visits = number of participants with treatment administered

DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]) and global health assessment (participant rated global assessment of disease activity using 10-mm Visual analog scale - VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. A DAS28 score of greater than (\>)5.1 indicated high disease activity, a score of \>3.2 but less than or equal to (≤)5.1 indicated moderate disease activity, a score of greater than or equal to (≥)2.6 but ≤3.2 indicated low disease activity, and a score of less than \<2.6 indicated disease remission. Week 24 is the Follow-Up visit.

Outcome measures

Outcome measures
Measure	Tocilizumab 8 mg/kg n=95 Participants Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category Remission Week 4 (n=93)	9.7 percentage of participants
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category High Disease Activity, Baseline (n=95)	66.3 percentage of participants
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category High Disease Activity, Week 8 (n=91)	5.5 percentage of participants
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category High Disease Activity, Week 12 (n=89)	2.2 percentage of participants
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category High Disease Activity, Week 16 (n=89)	3.4 percentage of participants
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category High Disease Activity, Week 4 (n=93)	15.1 percentage of participants
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category High Disease Activity, Week 20 (n=88)	1.1 percentage of participants
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category High Disease Activity, Week 24 (n=95)	0 percentage of participants
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category Moderate Disease Activity, Baseline (n=95)	33.7 percentage of participants
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category Moderate Disease Activity, Week 4 (n=93)	48.4 percentage of participants
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category Moderate Disease Activity, Week 8 (n=91)	36.3 percentage of participants
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category Moderate Disease Activity, Week 12 (n=89)	23.6 percentage of participants
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category Moderate Disease Activity, Week 16 (n=89)	11.2 percentage of participants
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category Moderate Disease Activity, Week 20 (n=88)	10.2 percentage of participants
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category Moderate Disease Activity, Week 24 (n=95)	7.4 percentage of participants
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category Low Disease Activity, Baseline (n=95)	0.0 percentage of participants
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category Low Disease Activity, Week 4 (n=93)	26.9 percentage of participants
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category Low Disease Activity, Week 8 (n=91)	26.4 percentage of participants
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category Low Disease Activity, Week 12 (n=89)	36.0 percentage of participants
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category Low Disease Activity, Week 16 (n=89)	16.9 percentage of participants
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category Low Disease Activity Week 20 (n=88)	15.9 percentage of participants
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category Low Disease Activity Week 24 (n=95)	23.2 percentage of participants
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category Remission Baseline (n=95)	0 percentage of participants
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category Remission Week 8 (n=91)	31.9 percentage of participants
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category Remission Week 12 (n=89)	38.2 percentage of participants
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category Remission Week 16 (n=89)	67.4 percentage of participants
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category Remission Week 20 (n=88)	67.4 percentage of participants
Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category Remission Week 24 (n=95)	64.2 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, and 24

Population: All the participants who were administered treatment at each visit were considered during the analysis. n at Week 24 = number of participants in that visit; n at Other Visits = number of participants with treatment administered

DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Participants achieved a clinically meaningful improvement in DAS28 if there was a reduction of at least 1.2 units from baseline.

Outcome measures

Outcome measures
Measure	Tocilizumab 8 mg/kg n=95 Participants Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
Percentage of Participants Achieving a Clinically Meaningful Improvement as Measured by DAS28 Week 4 (n=93)	82.8 percentage of participants
Percentage of Participants Achieving a Clinically Meaningful Improvement as Measured by DAS28 Week 8 (n=91)	92.3 percentage of participants
Percentage of Participants Achieving a Clinically Meaningful Improvement as Measured by DAS28 Week 12 (n=89)	95.5 percentage of participants
Percentage of Participants Achieving a Clinically Meaningful Improvement as Measured by DAS28 Week 16 (n=89)	95.5 percentage of participants
Percentage of Participants Achieving a Clinically Meaningful Improvement as Measured by DAS28 Week 20 (n=88)	94.3 percentage of participants
Percentage of Participants Achieving a Clinically Meaningful Improvement as Measured by DAS28 Week 24 (n=95)	91.6 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, and 24

Population: All the participants who were administered treatment at each visit were considered during the analysis.

Time to response is the number of days from date of first infusion to date of event. DAS28 response was defined as achievement of Low Disease Activity (DAS28 ≥2.6 to ≤3.2), Remission (DAS28 \<2.6), or Clinically Meaningful Improvement (change of \>1.2 from baseline).

Outcome measures

Outcome measures
Measure	Tocilizumab 8 mg/kg n=95 Participants Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
Time to DAS28 Response by DAS28 Category Remission (<2.6)	89.945 days Standard Error 4.395
Time to DAS28 Response by DAS28 Category Clinically meaningful Improvement in DAS28	36.430 days Standard Error 2.355
Time to DAS28 Response by DAS28 Category Low disease activity (≥2.6 to ≤3.2)	75.261 days Standard Error 5.587

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, and 24

HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.

Outcome measures

Outcome measures
Measure	Tocilizumab 8 mg/kg n=95 Participants Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at Least 0.22 Units Week 20 (n=88)	92.0 percentage of participants
Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at Least 0.22 Units Week 24 (n=95)	83.2 percentage of participants
Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at Least 0.22 Units Week 4 (n=93)	61.3 percentage of participants
Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at Least 0.22 Units Week 8 (n=91)	72.5 percentage of participants
Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at Least 0.22 Units Week 16 (n=89)	93.3 percentage of participants
Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at Least 0.22 Units Week 12 (n=89)	87.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24

Physical function scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. The HAQ-DI score at every visit was categorized into none to mild disability (HAQ-DI \<1), moderate disability (1≤ HAQ-DI \<2) and severe disability (HAQ-DI ≥2). The percentages of the participants falling in each of these categories with respect to the visits were determined.

Outcome measures

Outcome measures
Measure	Tocilizumab 8 mg/kg n=95 Participants Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
Percentage of Participants With Improvement in Physical Function by HAQ-DI Category ≤1 HAQ-DI <2 Week 4 (n=93)	46.2 percentage of participants
Percentage of Participants With Improvement in Physical Function by HAQ-DI Category ≤1 HAQ-DI <2 Week 8 (n=91)	39.6 percentage of participants
Percentage of Participants With Improvement in Physical Function by HAQ-DI Category ≤1 HAQ-DI <2 Week 12 (n=89)	34.8 percentage of participants
Percentage of Participants With Improvement in Physical Function by HAQ-DI Category ≤1 HAQ-DI <2 Week 16 (n=89)	25.8 percentage of participants
Percentage of Participants With Improvement in Physical Function by HAQ-DI Category HAQ-DI ≥2 Baseline (n=95)	24.2 percentage of participants
Percentage of Participants With Improvement in Physical Function by HAQ-DI Category HAQ-DI <1 Week 12 (n=89)	60.7 percentage of participants
Percentage of Participants With Improvement in Physical Function by HAQ-DI Category HAQ-DI <1 Week 16 (n=89)	73.0 percentage of participants
Percentage of Participants With Improvement in Physical Function by HAQ-DI Category HAQ-DI <1 Week 20 (n=88)	80.7 percentage of participants
Percentage of Participants With Improvement in Physical Function by HAQ-DI Category HAQ-DI <1 Week 24 (n=95)	71.6 percentage of participants
Percentage of Participants With Improvement in Physical Function by HAQ-DI Category HAQ-DI <1 Baseline (n=95)	13.7 percentage of participants
Percentage of Participants With Improvement in Physical Function by HAQ-DI Category HAQ-DI <1 Week 4 (n=93)	36.6 percentage of participants
Percentage of Participants With Improvement in Physical Function by HAQ-DI Category HAQ-DI <1 Week 8 (n=91)	50.5 percentage of participants
Percentage of Participants With Improvement in Physical Function by HAQ-DI Category ≤1 HAQ-DI <2 Baseline (n=95)	61.1 percentage of participants
Percentage of Participants With Improvement in Physical Function by HAQ-DI Category HAQ-DI ≥2 Week 12 (n=89)	4.5 percentage of participants
Percentage of Participants With Improvement in Physical Function by HAQ-DI Category HAQ-DI ≥2 Week 16 (n=89)	1.1 percentage of participants
Percentage of Participants With Improvement in Physical Function by HAQ-DI Category ≤1 HAQ-DI <2 Week 20 (n=88)	15.9 percentage of participants
Percentage of Participants With Improvement in Physical Function by HAQ-DI Category ≤1 HAQ-DI <2 Week 24 (n=95)	15.8 percentage of participants
Percentage of Participants With Improvement in Physical Function by HAQ-DI Category HAQ-DI ≥2 Week 20 (n=88)	2.3 percentage of participants
Percentage of Participants With Improvement in Physical Function by HAQ-DI Category HAQ-DI ≥2 Week 4 (n=93)	17.2 percentage of participants
Percentage of Participants With Improvement in Physical Function by HAQ-DI Category HAQ-DI ≥2 Week 24 (n=95)	3.2 percentage of participants
Percentage of Participants With Improvement in Physical Function by HAQ-DI Category HAQ-DI ≥2 Week 8 (n=91)	9.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, and 24

Outcome measures

Outcome measures
Measure	Tocilizumab 8 mg/kg n=95 Participants Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
HAQ-DI Score by Visit Baseline (n=95)	1.570 scores on a scale Standard Deviation 0.6157
HAQ-DI Score by Visit Week 4 (n=93)	1.185 scores on a scale Standard Deviation 0.7092
HAQ-DI Score by Visit Week 8 (n=91)	0.972 scores on a scale Standard Deviation 0.6236
HAQ-DI Score by Visit Week 12 (n=89)	0.805 scores on a scale Standard Deviation 0.5634
HAQ-DI Score by Visit Week 16 (n=89)	0.680 scores on a scale Standard Deviation 0.4804
HAQ-DI Score by Visit Week 20 (n=88)	0.576 scores on a scale Standard Deviation 0.4812
HAQ-DI Score by Visit Week 24 (n=95)	0.551 scores on a scale Standard Deviation 0.5139

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, and 24

Population: All the participants who were administered treatment at each visit were considered during the analysis.

CRP is an acute phase inflammatory marker. The serum concentration of CRP is measured in milligrams per liter (mg/L). A reduction in the level is considered an improvement.

Outcome measures

Outcome measures
Measure	Tocilizumab 8 mg/kg n=95 Participants Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
C-Reactive Protein (CRP) Values by Study Visit Baseline	26.90 mg/L Standard Deviation 34.406
C-Reactive Protein (CRP) Values by Study Visit Week 4	8.49 mg/L Standard Deviation 29.074
C-Reactive Protein (CRP) Values by Study Visit Week 8	7.84 mg/L Standard Deviation 23.116
C-Reactive Protein (CRP) Values by Study Visit Week 12	5.32 mg/L Standard Deviation 10.614
C-Reactive Protein (CRP) Values by Study Visit Week 16	5.18 mg/L Standard Deviation 8.105
C-Reactive Protein (CRP) Values by Study Visit Week 20	5.62 mg/L Standard Deviation 8.618
C-Reactive Protein (CRP) Values by Study Visit Week 24	8.59 mg/L Standard Deviation 21.702

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, and 24

Population: All the participants who were administered treatment at each visit were considered during the analysis.

ESR (measured in mm/hr) is an inflammation marker used to determine acute phase response.

Outcome measures

Outcome measures
Measure	Tocilizumab 8 mg/kg n=95 Participants Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
Erythrocyte Sedimentation Rate Week 24	9.17 mm/hr Standard Deviation 12.311
Erythrocyte Sedimentation Rate Baseline	45.27 mm/hr Standard Deviation 29.227
Erythrocyte Sedimentation Rate Week 4	10.61 mm/hr Standard Deviation 14.118
Erythrocyte Sedimentation Rate Week 8	7.66 mm/hr Standard Deviation 11.554
Erythrocyte Sedimentation Rate Week 12	7.52 mm/hr Standard Deviation 10.361
Erythrocyte Sedimentation Rate Week 16	5.83 mm/hr Standard Deviation 6.386
Erythrocyte Sedimentation Rate Week 20	6.60 mm/hr Standard Deviation 8.576

Adverse Events

Tocilizumab

Serious events: 8 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tocilizumab n=95 participants at risk Participants received tocilizumab 8 mg/kg iv infusion, every 4 weeks for a total of 6 infusions.
Metabolism and nutrition disorders Metabolism and nutrition disorders	3.2% 3/95 • Adverse events data were collected from the date of first dose of study drug administration to the end of study at Week 24. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events. Note that available data included a summary of events by system organ class only, no data provided by preferred term.
Investigations Investigations	2.1% 2/95 • Adverse events data were collected from the date of first dose of study drug administration to the end of study at Week 24. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events. Note that available data included a summary of events by system organ class only, no data provided by preferred term.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder	2.1% 2/95 • Adverse events data were collected from the date of first dose of study drug administration to the end of study at Week 24. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events. Note that available data included a summary of events by system organ class only, no data provided by preferred term.
Infections and infestations Infection and infestation	1.1% 1/95 • Adverse events data were collected from the date of first dose of study drug administration to the end of study at Week 24. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events. Note that available data included a summary of events by system organ class only, no data provided by preferred term.
Renal and urinary disorders Renal and urinary disorders	1.1% 1/95 • Adverse events data were collected from the date of first dose of study drug administration to the end of study at Week 24. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events. Note that available data included a summary of events by system organ class only, no data provided by preferred term.

Other adverse events

Other adverse events
Measure	Tocilizumab n=95 participants at risk Participants received tocilizumab 8 mg/kg iv infusion, every 4 weeks for a total of 6 infusions.
Investigations Investigations	30.5% 29/95 • Adverse events data were collected from the date of first dose of study drug administration to the end of study at Week 24. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events. Note that available data included a summary of events by system organ class only, no data provided by preferred term.
Blood and lymphatic system disorders Blood and lymphatic system disorders	7.4% 7/95 • Adverse events data were collected from the date of first dose of study drug administration to the end of study at Week 24. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events. Note that available data included a summary of events by system organ class only, no data provided by preferred term.
Infections and infestations Infections and infestations	7.4% 7/95 • Adverse events data were collected from the date of first dose of study drug administration to the end of study at Week 24. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events. Note that available data included a summary of events by system organ class only, no data provided by preferred term.
Metabolism and nutrition disorders Metabolism and nutrition disorders	7.4% 7/95 • Adverse events data were collected from the date of first dose of study drug administration to the end of study at Week 24. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events. Note that available data included a summary of events by system organ class only, no data provided by preferred term.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	5.3% 5/95 • Adverse events data were collected from the date of first dose of study drug administration to the end of study at Week 24. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events. Note that available data included a summary of events by system organ class only, no data provided by preferred term.
Gastrointestinal disorders Gastrointestinal disorders	4.2% 4/95 • Adverse events data were collected from the date of first dose of study drug administration to the end of study at Week 24. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events. Note that available data included a summary of events by system organ class only, no data provided by preferred term.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	4.2% 4/95 • Adverse events data were collected from the date of first dose of study drug administration to the end of study at Week 24. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events. Note that available data included a summary of events by system organ class only, no data provided by preferred term.
General disorders General disorders and administration site conditions	3.2% 3/95 • Adverse events data were collected from the date of first dose of study drug administration to the end of study at Week 24. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events. Note that available data included a summary of events by system organ class only, no data provided by preferred term.
Nervous system disorders Nervous system disorders	3.2% 3/95 • Adverse events data were collected from the date of first dose of study drug administration to the end of study at Week 24. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events. Note that available data included a summary of events by system organ class only, no data provided by preferred term.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic, and mediastinal disorders	3.2% 3/95 • Adverse events data were collected from the date of first dose of study drug administration to the end of study at Week 24. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events. Note that available data included a summary of events by system organ class only, no data provided by preferred term.
Cardiac disorders Cardiac disorders	1.1% 1/95 • Adverse events data were collected from the date of first dose of study drug administration to the end of study at Week 24. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events. Note that available data included a summary of events by system organ class only, no data provided by preferred term.
Injury, poisoning and procedural complications Injury, poisoning, and procedural complications	1.1% 1/95 • Adverse events data were collected from the date of first dose of study drug administration to the end of study at Week 24. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events. Note that available data included a summary of events by system organ class only, no data provided by preferred term.
Renal and urinary disorders Renal and urinary disorders	1.1% 1/95 • Adverse events data were collected from the date of first dose of study drug administration to the end of study at Week 24. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events. Note that available data included a summary of events by system organ class only, no data provided by preferred term.
Vascular disorders Vascular disorders	1.1% 1/95 • Adverse events data were collected from the date of first dose of study drug administration to the end of study at Week 24. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events. Note that available data included a summary of events by system organ class only, no data provided by preferred term.

Additional Information

Medical Communications

Hoffmann- LaRoche

Phone: 800-821-8590

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 after the first publication or presentation that involves the overall study. 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