Trial Outcomes & Findings for A Study to Evaluate Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus (BEGIN) (NCT NCT00539838)

NCT ID: NCT00539838

Last Updated: 2020-09-17

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

33 participants

Primary outcome timeframe

Week 48

Results posted on

2020-09-17

Participant Flow

A maximum screening window of 14 days was allowed.

During the screening period, participants received oral prednisone after the physician's evaluation and scoring of a BILAG questionnaire.

Participant milestones

Participant milestones
Measure	Ocrelizumab 1000 mg Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks	Ocrelizumab 400 mg Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks	Placebo Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks
Overall Study STARTED	12	11	10
Overall Study COMPLETED	5	5	1
Overall Study NOT COMPLETED	7	6	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Ocrelizumab 1000 mg Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks	Ocrelizumab 400 mg Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks	Placebo Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks
Overall Study Fail to return	2	0	0
Overall Study Withdrawal by Subject	0	4	0
Overall Study Death	0	2	0
Overall Study Did not cooperate	1	0	1
Overall Study Administrative	4	0	8

Baseline Characteristics

A Study to Evaluate Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus (BEGIN)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=10 Participants Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks	Ocrelizumab 400 mg n=11 Participants Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks	Ocrelizumab 1000 mg n=12 Participants Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks	Total n=33 Participants Total of all reporting groups
Age, Continuous	41.0 Years STANDARD_DEVIATION 13.82 • n=5 Participants	40.2 Years STANDARD_DEVIATION 8.80 • n=7 Participants	36.3 Years STANDARD_DEVIATION 11.31 • n=5 Participants	39.0 Years STANDARD_DEVIATION 11.24 • n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	11 Participants n=7 Participants	10 Participants n=5 Participants	30 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	21 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	20 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 48

Population: Evaluation of the primary and some secondary endpoints was to occur at Week 48 with further analyses conducted at Week 96. However, following the early termination of the study, the analysis of the primary and secondary endpoints were not conducted.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Week 48

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Week 48

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 24

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 48

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 48 to Week 96

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 48 to Week 96

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 48 to Week 96

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 48 to Week 72

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 48 to Week 96

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 48

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 48

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 48

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 48

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2.5 years

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Ocrelizumab 400 mg

Serious events: 6 serious events

Other events: 10 other events

Deaths: 0 deaths

Ocrelizumab 1000 mg

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

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

Measure	Placebo n=10 participants at risk Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks	Ocrelizumab 400 mg n=11 participants at risk Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks	Ocrelizumab 1000 mg n=12 participants at risk Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks
Infections and infestations CYTOMEGALOVIRUS	0.00% 0/10 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	9.1% 1/11 • Number of events 1 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	0.00% 0/12 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once
Infections and infestations CHORIORETINITIS	0.00% 0/10 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	9.1% 1/11 • Number of events 1 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	0.00% 0/12 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once
Infections and infestations PNEUMOCYSTIS JIROVECI	0.00% 0/10 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	0.00% 0/11 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	8.3% 1/12 • Number of events 1 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once
Infections and infestations PNEUMONIA	0.00% 0/10 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	9.1% 1/11 • Number of events 1 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	0.00% 0/12 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once
Infections and infestations SEPTIC SHOCK	0.00% 0/10 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	9.1% 1/11 • Number of events 1 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	0.00% 0/12 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.00% 0/10 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	9.1% 1/11 • Number of events 1 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	0.00% 0/12 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once
Infections and infestations URINARY TRACT INFECTION	0.00% 0/10 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	9.1% 1/11 • Number of events 1 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	0.00% 0/12 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once
Renal and urinary disorders NEPHROLITHIASIS	0.00% 0/10 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	0.00% 0/11 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	8.3% 1/12 • Number of events 1 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once
Renal and urinary disorders NEPHROTIC SYNDROME	0.00% 0/10 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	9.1% 1/11 • Number of events 1 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	0.00% 0/12 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once
Renal and urinary disorders RENAL FAILURE	0.00% 0/10 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	9.1% 1/11 • Number of events 1 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	0.00% 0/12 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once
Blood and lymphatic system disorders ANAEMIA	0.00% 0/10 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	9.1% 1/11 • Number of events 1 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	0.00% 0/12 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/10 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	9.1% 1/11 • Number of events 1 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	0.00% 0/12 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once
Cardiac disorders PERICARDITIS	0.00% 0/10 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	9.1% 1/11 • Number of events 1 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	8.3% 1/12 • Number of events 1 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once
Gastrointestinal disorders GASTRITIS	0.00% 0/10 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	9.1% 1/11 • Number of events 1 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	0.00% 0/12 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once
Hepatobiliary disorders HYPERBILIRUBINAEMIA	0.00% 0/10 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	9.1% 1/11 • Number of events 1 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	0.00% 0/12 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once
Musculoskeletal and connective tissue disorders SYSTEMIC LUPUS ERYTHEMATOSUS	0.00% 0/10 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	9.1% 1/11 • Number of events 1 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	0.00% 0/12 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once
Nervous system disorders SYNCOPE	0.00% 0/10 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	0.00% 0/11 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	8.3% 1/12 • Number of events 1 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once
Respiratory, thoracic and mediastinal disorders ASTHMA	0.00% 0/10 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	9.1% 1/11 • Number of events 1 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once	0.00% 0/12 • Baseline up to 42 months. Multiple occurrences of the same adverse event in one individual counted only once