Trial Outcomes & Findings for A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-α Therapy (SCRIPT) (NCT NCT00476996)

Last Updated: 2019-08-12

Results Overview

ACR20 response: greater than or equal to (≥) 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (visual analog scale \[VAS\]), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) erythrocyte sedimentation rate (ESR) at each visit.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

836 participants

Primary outcome timeframe

Weeks 24 and 48

Results posted on

2019-08-12

Participant Flow

Participants were recruited across 25 countries.

The study population comprised of adult participants with active RA of \>/= 3 months duration who had an inadequate clinical response due to toxicity or inadequate efficacy to previous or current treatment with one or more anti-TNF-alpha therapies.

Participant milestones

Participant milestones
Measure	Placebo x 2 IV + Non-Biologic DMARD Participants received Ocrelizumab matching placebo intravenously (IV) in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Ocrelizumab 200 mg x 2 + Non-Biologic DMARD Participants received 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab (total 400 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Ocrelizumab 500 mg x 2 + Non-Biologic DMARD Participants received 2 intravenous (IV) infusions of 500 milligram (mg) of ocrelizumab (total 1000 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Ocrelizumab 500 mg x 2 IV + Non-biologic DMARD (OLE) At the discretion of the investigator, eligible participants received 500 mg Ocrelizumab IV in two infusions separated by 14 days
Blinded Treatment Phase (up to Week 48) STARTED	277	277	282	0
Blinded Treatment Phase (up to Week 48) COMPLETED	205	222	237	0
Blinded Treatment Phase (up to Week 48) NOT COMPLETED	72	55	45	0
OLE Phase (From Week 48) STARTED	0	0	0	664
OLE Phase (From Week 48) COMPLETED	0	0	0	0
OLE Phase (From Week 48) NOT COMPLETED	0	0	0	664

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo x 2 IV + Non-Biologic DMARD Participants received Ocrelizumab matching placebo intravenously (IV) in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Ocrelizumab 200 mg x 2 + Non-Biologic DMARD Participants received 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab (total 400 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Ocrelizumab 500 mg x 2 + Non-Biologic DMARD Participants received 2 intravenous (IV) infusions of 500 milligram (mg) of ocrelizumab (total 1000 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Ocrelizumab 500 mg x 2 IV + Non-biologic DMARD (OLE) At the discretion of the investigator, eligible participants received 500 mg Ocrelizumab IV in two infusions separated by 14 days
Blinded Treatment Phase (up to Week 48) Withdrawal by Subject	12	7	7	0
Blinded Treatment Phase (up to Week 48) Protocol Violation	1	3	0	0
Blinded Treatment Phase (up to Week 48) Early termination of the study	24	20	21	0
Blinded Treatment Phase (up to Week 48) Non-Compliance with Study Drug	0	2	0	0
Blinded Treatment Phase (up to Week 48) Lost to Follow-up	0	4	3	0
Blinded Treatment Phase (up to Week 48) Lack of Efficacy	22	5	6	0
Blinded Treatment Phase (up to Week 48) Death	2	1	1	0
Blinded Treatment Phase (up to Week 48) Adverse Event	11	13	7	0
OLE Phase (From Week 48) Withdrawal by Subject	0	0	0	50
OLE Phase (From Week 48) Adverse Event	0	0	0	8
OLE Phase (From Week 48) Death	0	0	0	7
OLE Phase (From Week 48) Lack of Efficacy	0	0	0	13
OLE Phase (From Week 48) Lost to Follow-up	0	0	0	4
OLE Phase (From Week 48) Non-Compliance with Study Drug	0	0	0	4
OLE Phase (From Week 48) Early termination of the study	0	0	0	578

Baseline Characteristics

A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-α Therapy (SCRIPT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo x 2 IV + Non-Biologic DMARD n=277 Participants Participants received Ocrelizumab matching placebo intravenously (IV) in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Ocrelizumab 200 mg x 2 + Non-Biologic DMARD n=277 Participants Participants received 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab (total 400 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Ocrelizumab 500 mg x 2 + Non-Biologic DMARD n=282 Participants Participants received 2 intravenous (IV) infusions of 500 milligram (mg) of ocrelizumab (total 1000 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Total n=836 Participants Total of all reporting groups
Age, Continuous	54.1 years STANDARD_DEVIATION 11.3 • n=5 Participants	54.5 years STANDARD_DEVIATION 11.2 • n=7 Participants	53.8 years STANDARD_DEVIATION 11.6 • n=5 Participants	54.2 years STANDARD_DEVIATION 11.3 • n=4 Participants
Sex: Female, Male Female	215 Participants n=5 Participants	214 Participants n=7 Participants	236 Participants n=5 Participants	665 Participants n=4 Participants
Sex: Female, Male Male	62 Participants n=5 Participants	63 Participants n=7 Participants	46 Participants n=5 Participants	171 Participants n=4 Participants
Race/Ethnicity, Customized American indian or Alaska native	9 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	26 Participants n=4 Participants
Race/Ethnicity, Customized Asian (Indian Subcontinent)	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Asian (Other than Indian subcontinent)	39 Participants n=5 Participants	38 Participants n=7 Participants	38 Participants n=5 Participants	115 Participants n=4 Participants
Race/Ethnicity, Customized Black	16 Participants n=5 Participants	18 Participants n=7 Participants	12 Participants n=5 Participants	46 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Other	6 Participants n=5 Participants	11 Participants n=7 Participants	14 Participants n=5 Participants	31 Participants n=4 Participants
Race/Ethnicity, Customized White	206 Participants n=5 Participants	201 Participants n=7 Participants	207 Participants n=5 Participants	614 Participants n=4 Participants

PRIMARY outcome

Timeframe: Weeks 24 and 48

Population: Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.

Outcome measures

Outcome measures
Measure	Placebo x 2 IV + Non-Biologic DMARD n=277 Participants Participants received Ocrelizumab matching placebo intravenously (IV) in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Ocrelizumab 200 mg x 2 + Non-Biologic DMARD n=277 Participants Participants received 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab (total 400 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Ocrelizumab 500 mg x 2 + Non-Biologic DMARD n=282 Participants Participants received 2 intravenous (IV) infusions of 500 milligram (mg) of ocrelizumab (total 1000 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
Percentage of Participants With American College of Rheumatology 20 (ACR20) Responses Percentage of Responders at Week 24	22 Percentage Interval 17.1 to 26.9	42.2 Percentage Interval 36.4 to 48.1	47.9 Percentage Interval 42.0 to 53.7
Percentage of Participants With American College of Rheumatology 20 (ACR20) Responses Percentage of Responders at Week 48	19.5 Percentage Interval 14.8 to 24.2	48.7 Percentage Interval 42.9 to 54.6	50.7 Percentage Interval 44.9 to 56.5

SECONDARY outcome

Timeframe: Week 48

Major clinical response was defined as achieving an ACR70 response and maintaining this response for a consecutive period of at least 6 months.

Outcome measures

Outcome measures
Measure	Placebo x 2 IV + Non-Biologic DMARD n=277 Participants Participants received Ocrelizumab matching placebo intravenously (IV) in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Ocrelizumab 200 mg x 2 + Non-Biologic DMARD n=277 Participants Participants received 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab (total 400 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Ocrelizumab 500 mg x 2 + Non-Biologic DMARD n=282 Participants Participants received 2 intravenous (IV) infusions of 500 milligram (mg) of ocrelizumab (total 1000 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
Percentage of Participants With a Major Clinical Response	1.8 Percentage Interval 0.2 to 3.4	4.0 Percentage Interval 1.7 to 6.3	5.7 Percentage Interval 3.0 to 8.4

SECONDARY outcome

Timeframe: Weeks 24 and 48

The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score \< 2.6.

Outcome measures

Outcome measures
Measure	Placebo x 2 IV + Non-Biologic DMARD n=277 Participants Participants received Ocrelizumab matching placebo intravenously (IV) in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Ocrelizumab 200 mg x 2 + Non-Biologic DMARD n=277 Participants Participants received 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab (total 400 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Ocrelizumab 500 mg x 2 + Non-Biologic DMARD n=282 Participants Participants received 2 intravenous (IV) infusions of 500 milligram (mg) of ocrelizumab (total 1000 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
Percentage of Participants Achieving Disease Activity Score (DAS28) Remission Percentage of Participants at Week 24	1.8 Percentage Interval 0.2 to 3.4	5.8 Percentage Interval 3.0 to 8.5	6.0 Percentage Interval 3.3 to 8.8
Percentage of Participants Achieving Disease Activity Score (DAS28) Remission Percentage of Participants at Week 48	1.4 Percentage Interval 0.0 to 2.8	11.9 Percentage Interval 8.1 to 15.7	12.1 Percentage Interval 8.3 to 15.9

SECONDARY outcome

Timeframe: Weeks 24 and 48

Population: Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis Number of participants for whom data were collected is indicated for each time point.

Outcome measures

Outcome measures
Measure	Placebo x 2 IV + Non-Biologic DMARD n=277 Participants Participants received Ocrelizumab matching placebo intravenously (IV) in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Ocrelizumab 200 mg x 2 + Non-Biologic DMARD n=277 Participants Participants received 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab (total 400 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Ocrelizumab 500 mg x 2 + Non-Biologic DMARD n=282 Participants Participants received 2 intravenous (IV) infusions of 500 milligram (mg) of ocrelizumab (total 1000 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
Change in DAS28 From Baseline Baseline	6.50 Score on a scale Standard Deviation 1.014	6.47 Score on a scale Standard Deviation 1.217	6.44 Score on a scale Standard Deviation 1.039
Change in DAS28 From Baseline Week 24	-0.99 Score on a scale Standard Deviation 1.166	-1.60 Score on a scale Standard Deviation 1.307	-1.91 Score on a scale Standard Deviation 1.349
Change in DAS28 From Baseline Week 48	-1.13 Score on a scale Standard Deviation 1.404	-2.11 Score on a scale Standard Deviation 1.348	-2.38 Score on a scale Standard Deviation 1.496

SECONDARY outcome

Timeframe: Weeks 24 and 48

The EULAR response rate was based on the assessment of disease activity using the DAS28. The EULAR response criteria included not only change in disease activity but current disease activity. To be classified as responders, participants had to have a significant change in DAS28 and a low current disease activity. There were 4 categories of EULAR response rates: good, moderate, good/moderate, and none.

Outcome measures

Outcome measures
Measure	Placebo x 2 IV + Non-Biologic DMARD n=277 Participants Participants received Ocrelizumab matching placebo intravenously (IV) in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Ocrelizumab 200 mg x 2 + Non-Biologic DMARD n=277 Participants Participants received 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab (total 400 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Ocrelizumab 500 mg x 2 + Non-Biologic DMARD n=282 Participants Participants received 2 intravenous (IV) infusions of 500 milligram (mg) of ocrelizumab (total 1000 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
Percentage of Participants With EULAR Response Rates of Good/ Moderate Week 24	31.4 Percentage	54.2 Percentage	61.0 Percentage
Percentage of Participants With EULAR Response Rates of Good/ Moderate Week 48	24.9 Percentage	58.8 Percentage	60.3 Percentage

SECONDARY outcome

Timeframe: Weeks 24 and 48

ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: physician's global assessment of disease activity (MDG), patient's global assessment of disease activity (PGA), patient's assessment of pain, Health Assessment Questionnaire with Disability Index (HAQ-DI), and C-Reactive Protein (CRP).

Outcome measures

Outcome measures
Measure	Placebo x 2 IV + Non-Biologic DMARD n=277 Participants Participants received Ocrelizumab matching placebo intravenously (IV) in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Ocrelizumab 200 mg x 2 + Non-Biologic DMARD n=277 Participants Participants received 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab (total 400 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Ocrelizumab 500 mg x 2 + Non-Biologic DMARD n=282 Participants Participants received 2 intravenous (IV) infusions of 500 milligram (mg) of ocrelizumab (total 1000 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
Percentage of Participants Achieving an ACR50 Response Percentage of Participants at Week 24	7.9 Percentage Interval 4.8 to 11.1	21.3 Percentage Interval 16.5 to 26.1	24.8 Percentage Interval 19.8 to 29.9
Percentage of Participants Achieving an ACR50 Response Percentage of Participants at Week 48	9 Percentage Interval 5.7 to 12.4	28.5 Percentage Interval 23.2 to 33.8	30.9 Percentage Interval 25.5 to 36.2

SECONDARY outcome

Timeframe: Weeks 24 and 48

ACR70 response is defined as a ≥ 70% improvement (reduction) compared with Baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: physician's global assessment of disease activity (MDG), patient's global assessment of disease activity (PGA), patient's assessment of pain, HAQ-DI and CRP.

Outcome measures

Outcome measures
Measure	Placebo x 2 IV + Non-Biologic DMARD n=277 Participants Participants received Ocrelizumab matching placebo intravenously (IV) in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Ocrelizumab 200 mg x 2 + Non-Biologic DMARD n=277 Participants Participants received 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab (total 400 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Ocrelizumab 500 mg x 2 + Non-Biologic DMARD n=282 Participants Participants received 2 intravenous (IV) infusions of 500 milligram (mg) of ocrelizumab (total 1000 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
Percentage of Participants Achieving an ACR70 Response Percentage of Participants at Week 24	2.9 Percentage Interval 0.9 to 4.9	7.6 Percentage Interval 4.5 to 10.7	9.9 Percentage Interval 6.4 to 13.4
Percentage of Participants Achieving an ACR70 Response Percentage of Participants at Week 48	4.3 Percentage Interval 1.9 to 6.7	11.2 Percentage Interval 7.5 to 14.9	18.1 Percentage Interval 13.6 to 22.6

SECONDARY outcome

Timeframe: Weeks 24 and 48

Health Assessment Questionnaire - Disability Index (HAQ-DI): The Stanford Health Assessment Questionnaire disability index is a patient reported questionnaire specific for RA. It consists of 20 questions referring to eight component. Reduction in the HAQ-DI score of 0.25 units from baseline to weeks 24 and 48 represented a minimal clinically relevant improvement.

Outcome measures

Outcome measures
Measure	Placebo x 2 IV + Non-Biologic DMARD n=277 Participants Participants received Ocrelizumab matching placebo intravenously (IV) in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Ocrelizumab 200 mg x 2 + Non-Biologic DMARD n=277 Participants Participants received 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab (total 400 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Ocrelizumab 500 mg x 2 + Non-Biologic DMARD n=282 Participants Participants received 2 intravenous (IV) infusions of 500 milligram (mg) of ocrelizumab (total 1000 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
Percentage of Participants With a Reduction in the HAQ-DI Score Percentage of Participants at Week 24	32.9 Percentage Interval 27.3 to 38.4	52.3 Percentage Interval 46.5 to 58.2	58.5 Percentage Interval 52.8 to 64.3
Percentage of Participants With a Reduction in the HAQ-DI Score Percentage of Participants at Week 48	23.1 Percentage Interval 18.1 to 28.1	50.5 Percentage Interval 44.7 to 56.4	51.8 Percentage Interval 45.9 to 57.6

Adverse Events

Placebo x 2 IV + Non-Biologic DMARD

Serious events: 41 serious events

Other events: 152 other events

Deaths: 5 deaths

Ocrelizumab 200 mg x 2 + Non-Biologic DMARD

Serious events: 46 serious events

Other events: 153 other events

Deaths: 2 deaths

Ocrelizumab 500 mg x 2 + Non-Biologic DMARD

Serious events: 40 serious events

Other events: 158 other events

Deaths: 4 deaths

Ocrelizumab 500 mg x 2 IV + Non-biologic DMARD (OLE)

Serious events: 138 serious events

Other events: 361 other events

Deaths: 11 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo x 2 IV + Non-Biologic DMARD n=276 participants at risk Participants received Ocrelizumab matching placebo intravenously (IV) in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Ocrelizumab 200 mg x 2 + Non-Biologic DMARD n=276 participants at risk Participants received 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab (total 400 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Ocrelizumab 500 mg x 2 + Non-Biologic DMARD n=284 participants at risk Participants received 2 intravenous (IV) infusions of 500 milligram (mg) of ocrelizumab (total 1000 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Ocrelizumab 500 mg x 2 IV + Non-biologic DMARD (OLE) n=664 participants at risk At the discretion of the investigator, eligible participants received 500 mg Ocrelizumab IV in two infusions separated by 14 days
Gastrointestinal disorders Darrhoea	3.6% 10/276 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	5.4% 15/276 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	5.3% 15/284 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	0.00% 0/664 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.
Gastrointestinal disorders Nausea	5.4% 15/276 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	4.0% 11/276 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	3.5% 10/284 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	0.00% 0/664 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.
Infections and infestations Bronchitis	6.9% 19/276 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	10.1% 28/276 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	7.7% 22/284 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	9.6% 64/664 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.
Infections and infestations Influenza	3.3% 9/276 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	2.5% 7/276 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	5.3% 15/284 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	0.00% 0/664 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.
Infections and infestations Nasopharyngitis	11.2% 31/276 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	10.1% 28/276 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	7.7% 22/284 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	10.4% 69/664 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.
Infections and infestations Sinusitis	5.1% 14/276 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	4.7% 13/276 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	4.6% 13/284 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	8.0% 53/664 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.
Infections and infestations Upper respiratory tract infection	13.0% 36/276 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	13.4% 37/276 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	15.8% 45/284 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	14.5% 96/664 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.
Infections and infestations Urinary tract infection	8.3% 23/276 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	6.9% 19/276 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	8.5% 24/284 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	11.7% 78/664 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.
Injury, poisoning and procedural complications Infusion related reaction	9.1% 25/276 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	14.9% 41/276 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	14.4% 41/284 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	19.3% 128/664 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.
Nervous system disorders Headache	5.4% 15/276 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	4.3% 12/276 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	5.3% 15/284 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	0.00% 0/664 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.
Psychiatric disorders Insomnia	4.3% 12/276 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	3.3% 9/276 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	5.6% 16/284 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	0.00% 0/664 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.
Vascular disorders Hypertension	7.6% 21/276 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	6.5% 18/276 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	6.7% 19/284 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.	6.6% 44/664 • From Day 1 to Week 48 and Week 96 The safety population included all participants who received at least one treatment with study medication. In the safety population patients are categorized as treated, the ITT population as randomized. One patient randomized to Placebo and one patient randomized to the OCR 200 mg group, received at least one dose of OCR 500 mg.

Additional Information

Medical Communications

Hoffmann-La Roche

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 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