Trial Outcomes & Findings for An Observational Quality of Life Study in Participants With Rheumatoid Arthritis Treated With Rituximab (NCT NCT02507752)

Last Updated: 2016-02-02

Results Overview

The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. The proportion of participants achieving a clinically important reduction of \>= 0.22 point in HAQ (disease-specific questionnaire) at Week 24 was evaluated. HAQ was assessed using the set of observed cases (OC) at each assessment time. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement.

Recruitment status

COMPLETED

Target enrollment

94 participants

Primary outcome timeframe

Week 24

Results posted on

2016-02-02

Participant Flow

A total of 95 participants were screened for eligibility between July 2009 and December 2011 at 16 centers in Brazil.

Out of 95 participants, 72 who answered at least one short form 36 (SF-36) questionnaire made up the Intent-to-treat (ITT) population

Participant milestones

Participant milestones
Measure	Rituximab Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
Overall Study STARTED	72
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Rituximab Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
Overall Study Adverse Event	1
Overall Study Protocol Violation	6
Overall Study Lost to Follow-up	7
Overall Study Infusion reaction at first infusion	1
Overall Study Participant didn't perform visit Week 12	1
Overall Study Participant didn't perform visit Week 24	1

Baseline Characteristics

An Observational Quality of Life Study in Participants With Rheumatoid Arthritis Treated With Rituximab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rituximab n=72 Participants Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
Age, Continuous	52.3 years STANDARD_DEVIATION 12.3 • n=99 Participants
Sex: Female, Male Female	65 Participants n=99 Participants
Sex: Female, Male Male	7 Participants n=99 Participants

PRIMARY outcome

Timeframe: Week 24

Population: The ITT population included all screened participants who answered at least one SF-36 questionnaire.

Outcome measures

Outcome measures
Measure	Rituximab n=38 Participants Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
Percentage of Participants Achieving an Improvement of at Least 0.22 Units in Health Assessment Questionnaire (HAQ) at Week 24	57.9 Percentage Interval 42.2 to 72.1

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = number of participants analyzed for a given component of SF-36.

SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary. SF-36 was assessed using the set of observed cases (OC) at each assessment time.

Outcome measures

Outcome measures
Measure	Rituximab n=72 Participants Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
Mean Change From Baseline in the Short-Form (SF-36) Health Survey Physical Component Score and Mental Component Score at Week 24 Physical component score, n = 36	14.6 scores on a scale Standard Error 2.5
Mean Change From Baseline in the Short-Form (SF-36) Health Survey Physical Component Score and Mental Component Score at Week 24 Mental component score, n = 38	9.8 scores on a scale Standard Error 3.8

SECONDARY outcome

Timeframe: Up to 24 Weeks

Population: The ITT population included all screened participants who answered at least one SF-36 questionnaire.

An infusion reaction is defined as an adverse event that occurs during infusion or within 24 hours after infusion of Rituximab. All infectious events, whether considered related or not to Rituximab, were collected for the safety analysis of the study. An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Outcome measures

Outcome measures
Measure	Rituximab n=72 Participants Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
Number of Participants With Infusion Reactions, Infectious Events and / or Other Adverse Events in the 24 Weeks After the Start of Treatment. Infusion reactions	15 participants
Number of Participants With Infusion Reactions, Infectious Events and / or Other Adverse Events in the 24 Weeks After the Start of Treatment. Infectious events	5 participants
Number of Participants With Infusion Reactions, Infectious Events and / or Other Adverse Events in the 24 Weeks After the Start of Treatment. Adverse events	21 participants

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

Population: The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.

Erythrocyte Sedimentation Rate is an acute phase reactant and a measure of inflammation.

Outcome measures

Outcome measures
Measure	Rituximab n=72 Participants Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Week 12 (n = 48)	-7.5 mm/hr Standard Error 3.1
Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Week 24 (n = 46)	-11.5 mm/hr Standard Error 3.7

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

Population: The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.

CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as Rheumatoid Arthritis.

Outcome measures

Outcome measures
Measure	Rituximab n=72 Participants Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
Mean Change From Baseline in C-reactive Protein (CRP). Week 24 (n = 36)	-0.5 mg/L Standard Error 1
Mean Change From Baseline in C-reactive Protein (CRP). Week 12 (n = 37)	-0.3 mg/L Standard Error 0.9

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

Population: The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.

A swollen joint count is the most specific clinical method to quantify abnormalities in participants with rheumatoid arthritis (RA). It reflects the amount of inflamed synovial tissue.

Outcome measures

Outcome measures
Measure	Rituximab n=72 Participants Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
Mean Change From Baseline in Swollen Joint Count (SJC) Week 12 (n = 58)	-5.2 Number of swollen joints Standard Error 0.6
Mean Change From Baseline in Swollen Joint Count (SJC) Week 24 (n = 56)	-5.1 Number of swollen joints Standard Error 0.7

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

Population: The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.

A tender joint count is the most specific clinical method to quantify abnormalities in participants with rheumatoid arthritis (RA). It is associated more with the level of pain.

Outcome measures

Outcome measures
Measure	Rituximab n=72 Participants Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
Mean Change From Baseline in Tender Joint Count (TJC) Week 12 (n = 58)	-6 Number of tender joints Standard Error 0.8
Mean Change From Baseline in Tender Joint Count (TJC) Week 24 (n = 56)	-7 Number of tender joints Standard Error 0.9

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

Population: The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.

DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=\<) 3.2 = low disease activity, a DAS28 score of \>3.2 to 5.1 = moderate to high disease activity.

Outcome measures

Outcome measures
Measure	Rituximab n=72 Participants Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
Mean Change From Baseline in Disease Activity Score 28 Joints (DAS28) Score Week 12 (n = 48)	-1.5 Units on a scale Standard Error 0.2
Mean Change From Baseline in Disease Activity Score 28 Joints (DAS28) Score Week 24 (n = 46)	-1.7 Units on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

Population: The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.

The Physician's Global Assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity).Change from Baseline = scores at observation minus score at Baseline. An increase in score from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.

Outcome measures

Outcome measures
Measure	Rituximab n=72 Participants Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
Mean Change From Baseline in Patient Global Assessment (100 mm VAS) Week 12 (n = 58)	-25.6 Units on a scale Standard Error 3.2
Mean Change From Baseline in Patient Global Assessment (100 mm VAS) Week 24 (n = 56)	-23.6 Units on a scale Standard Error 3.3

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

Population: The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.

The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. The number of participants achieving a clinically important reduction of \>= 0.22 point in HAQ (disease-specific questionnaire) at Week 24 was evaluated. HAQ was assessed using the set of observed cases (OC) at each assessment time. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement.

Outcome measures

Outcome measures
Measure	Rituximab n=72 Participants Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
Change in HAQ Score From Screening to Weeks 12 and 24 Week 12 (n = 40)	-0.22 Units on a scale Standard Error 0.08
Change in HAQ Score From Screening to Weeks 12 and 24 Week 24 (n = 38)	-0.31 Units on a scale Standard Error 0.09

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

Population: The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.

Visual Analogue Scale (VAS) is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change from Screening=scores at observation minus score at Screening. An increase in score from Screening represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. The change in pain scale was analyzed for the set of observed cases (OC) at each assessment time.

Outcome measures

Outcome measures
Measure	Rituximab n=72 Participants Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
Change in Pain Scale (100-mm VAS) From Screening to Weeks 12 and 24 Week 12 (n = 40)	-17.9 Units on a scale Standard Error 3.7
Change in Pain Scale (100-mm VAS) From Screening to Weeks 12 and 24 Week 24 (n = 37)	-20.7 Units on a scale Standard Error 3.6

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed for a particular component of SF-36.

Outcome measures

Outcome measures
Measure	Rituximab n=72 Participants Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
Change in SF-36 Physical and Mental Component Scores From Screening to Week 12 SF-36 Physical component score (n = 39)	11.2 scores on a scale Standard Error 3.1
Change in SF-36 Physical and Mental Component Scores From Screening to Week 12 SF-36 Mental component score (n = 39)	10.9 scores on a scale Standard Error 3.1

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24

Population: The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed for a particular domain of SF-36.

Outcome measures

Outcome measures
Measure	Rituximab n=72 Participants Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
Change in SF-36 Domain Scores From Screening to Week (Wk) 12 and 24 Wk 12, Physical functioning domain, n = 39	7.2 scores on a scale Standard Error 4.3
Change in SF-36 Domain Scores From Screening to Week (Wk) 12 and 24 Wk 24, Physical functioning domain, n = 38	7.6 scores on a scale Standard Error 2.7
Change in SF-36 Domain Scores From Screening to Week (Wk) 12 and 24 Wk 12, Role physical domain, n = 39	15.4 scores on a scale Standard Error 5.5
Change in SF-36 Domain Scores From Screening to Week (Wk) 12 and 24 Wk 24, Role physical domain, n = 38	21.6 scores on a scale Standard Error 4.7
Change in SF-36 Domain Scores From Screening to Week (Wk) 12 and 24 Wk 12, Bodily pain domain, n = 40	14.2 scores on a scale Standard Error 4.1
Change in SF-36 Domain Scores From Screening to Week (Wk) 12 and 24 Wk 24, Bodily pain domain, n = 37	17.6 scores on a scale Standard Error 3.2
Change in SF-36 Domain Scores From Screening to Week (Wk) 12 and 24 Wk 12, General health domain, n = 40	6.7 scores on a scale Standard Error 3.7
Change in SF-36 Domain Scores From Screening to Week (Wk) 12 and 24 Wk 24, General health domain, n = 37	7.7 scores on a scale Standard Error 4.1
Change in SF-36 Domain Scores From Screening to Week (Wk) 12 and 24 Wk 12, Vitality domain, n = 40	6.9 scores on a scale Standard Error 2.8
Change in SF-36 Domain Scores From Screening to Week (Wk) 12 and 24 Wk 24, Vitality domain, n = 38	7.4 scores on a scale Standard Error 3.7
Change in SF-36 Domain Scores From Screening to Week (Wk) 12 and 24 Wk 12, Social functioning domain, n = 40	15 scores on a scale Standard Error 4.4
Change in SF-36 Domain Scores From Screening to Week (Wk) 12 and 24 Wk 24, Social functioning domain, n = 38	15.5 scores on a scale Standard Error 4.9
Change in SF-36 Domain Scores From Screening to Week (Wk) 12 and 24 Wk 12, Role emotional domain, n = 39	12.4 scores on a scale Standard Error 4.8
Change in SF-36 Domain Scores From Screening to Week (Wk) 12 and 24 Wk 24, Role emotional domain, n = 38	7.7 scores on a scale Standard Error 5.3
Change in SF-36 Domain Scores From Screening to Week (Wk) 12 and 24 Wk 12, Mental health domain, n = 40	8 scores on a scale Standard Error 3.4
Change in SF-36 Domain Scores From Screening to Week (Wk) 12 and 24 Wk 24, Mental health domain, n = 38	8.8 scores on a scale Standard Error 3.9

SECONDARY outcome

Timeframe: Week 12

Population: The ITT population included all screened participants who answered at least one SF-36 questionnaire.

Outcome measures

Outcome measures
Measure	Rituximab n=40 Participants Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
Percentage of Participants Achieving a Clinically Important Reduction of >= 0.22 Point in HAQ Score at Week 12.	47.5 Percentage Interval 32.9 to 62.5

SECONDARY outcome

Timeframe: Week 12 and 24

Population: The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = number of participants analyzed for a given component of SF-36.

Outcome measures

Outcome measures
Measure	Rituximab n=72 Participants Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
Percentage of Participants Achieving a Clinically Important Increase of >=5 Points in the SF-36 Physical and Mental Component Scores at Weeks 12 and 24. Physical component score, Week 12, n = 39	74.4 Percentage Interval 58.9 to 85.4
Percentage of Participants Achieving a Clinically Important Increase of >=5 Points in the SF-36 Physical and Mental Component Scores at Weeks 12 and 24. Physical component score, Week 24, n = 36	69.4 Percentage Interval 53.1 to 82.0
Percentage of Participants Achieving a Clinically Important Increase of >=5 Points in the SF-36 Physical and Mental Component Scores at Weeks 12 and 24. Mental component score, Week 12, n = 39	74.4 Percentage Interval 58.9 to 85.4
Percentage of Participants Achieving a Clinically Important Increase of >=5 Points in the SF-36 Physical and Mental Component Scores at Weeks 12 and 24. Mental component score, Week 24, n = 38	65.8 Percentage Interval 49.9 to 78.8

Adverse Events

Rituximab

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rituximab n=72 participants at risk Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
Infections and infestations Urinary tract infection	1.4% 1/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Nervous system disorders Cerebrovascular accident	1.4% 1/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.

Other adverse events

Other adverse events
Measure	Rituximab n=72 participants at risk Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
Musculoskeletal and connective tissue disorders Arthritis	2.8% 2/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Musculoskeletal and connective tissue disorders Osteoarthritis	2.8% 2/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Musculoskeletal and connective tissue disorders Arthralgia	1.4% 1/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Musculoskeletal and connective tissue disorders Muscle spasms	1.4% 1/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.4% 1/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Infections and infestations Influenza	2.8% 2/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Infections and infestations Urinary tract infection	1.4% 1/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Infections and infestations Secondary syphilis	1.4% 1/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Infections and infestations Viral infection	1.4% 1/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Gastrointestinal disorders Dyspepsia	2.8% 2/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Gastrointestinal disorders Constipation	1.4% 1/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Gastrointestinal disorders Diarrhoea	1.4% 1/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Nervous system disorders Dizziness	1.4% 1/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Nervous system disorders Headache	1.4% 1/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Nervous system disorders Paraesthesia	1.4% 1/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Blood and lymphatic system disorders Leukopenia	1.4% 1/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Blood and lymphatic system disorders White blood cell disorder	1.4% 1/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Endocrine disorders Hypothyroidism	2.8% 2/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
General disorders Pain	1.4% 1/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
General disorders Pyrexia	1.4% 1/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Investigations Blood cholesterol increased	1.4% 1/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Investigations Gamma-glutamyltransferase increased	1.4% 1/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Psychiatric disorders Anxiety	1.4% 1/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Psychiatric disorders Depression	1.4% 1/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Skin and subcutaneous tissue disorders Alopecia	1.4% 1/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Skin and subcutaneous tissue disorders Pruritus	1.4% 1/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Vascular disorders Hypertension	2.8% 2/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Vascular disorders Phlebitis	1.4% 1/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Injury, poisoning and procedural complications Fall	1.4% 1/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Respiratory, thoracic and mediastinal disorders Cough	1.4% 1/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.4% 1/72 • Up to Week 24 An AE was defined as any sign or symptom, including intercurrent illness, that occurred during the course of the study after treatment had started, ie, events that were not present when the participant entered the study or events present at baseline that became worse, whether considered related to treatment or not.

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