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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00539838
• Date of registration: 03/10/2007
• Prospective Registration: Yes
• Primary sponsor: Genentech, Inc.
• Public title: A Study to Evaluate Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus (BEGIN) BEGIN
• Scientific title: A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus
• Date of first enrolment: December 19, 2007
• Target sample size: 33
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00539838
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Jorn Drappa, M.D., Ph.D.
• Affiliation: Genentech, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age 16 years or above at the time of screening

- Diagnosis of SLE

- Active disease at screening

Exclusion Criteria:

- Presence of active moderate to severe glomerulonephritis

- Currently active retinitis, poorly controlled seizure disorder, acute confusional
state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia

- Lack of peripheral venous access

- Pregnancy or breast feeding mothers

- History of severe allergic or anaphylactic reactions to humanized, chimeric or murine
monoclonal antibodies or i.v. immunoglobulin

- Known severe chronic pulmonary disease

- Evidence of significant or uncontrolled concomitant diseases in any organ system not
related to SLE, which, in the investigator's opinion, would impair patient
participation

- Concomitant condition which has required treatment with systemic corticosteroid
(excluding topical or inhaled) at any time in the 52 weeks prior to screening

- Known HIV or chronic active Hepatitis B or chronic active Hepatitis C infection

- Known active infection of any kind (but excluding fungal infection of nail beds or
oral thrush which has resolved before Day 1) within 30 days prior to Day 1. In
addition, any major episode of infection requiring hospitalization or treatment with
intravenous anti-infectives in the 30 days prior to Day 1 or oral anti-infectives in
the 14 days prior to Day 1

- History of serious recurrent or chronic infection

- History of cancer (except basal cell carcinoma of the skin that has been excised and
cured)

- History of alcohol or drug abuse in the 52 weeks prior to screening

- Major surgery in the 4 weeks prior to screening excluding diagnostic surgery

- Previous treatment with CAMPATH-1H

- Previous treatment with a BAFF directed treatment in the 12 months prior to screening

- Previous treatment with a B-cell targeted therapy other than one directed at BAFF

- Treatment with any investigational agent, other than those above, in the 28 days prior
to screening or five half-lives of the investigational drug (whichever is longer)

- Receipt of any live vaccine in the 6 weeks prior to Day 1

- Intolerance or contraindication to oral or i.v. corticosteroids

- Treatment with a second immunosuppressive or immunomodulatory drug in the 8 weeks
prior to Day 1

- Prednisone dose of = 0.7 mg/kg/day (or equivalent) for > 7 of the previous 30 days
prior to screening

- Treatment with cyclophosphamide or a calcineurin inhibitor in the 12 weeks prior to
screening

- Positive hepatitis BsAg or hepatitis C serology. Patients who are HBsAg negative but
HBcAb positive may be enrolled with a negative DNA test



Age minimum: 16 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Placebo

Drug: Ocrelizumab

Drug: Prednisone

Drug: Methylprednisolone

Drug: Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate)

Primary Outcome(s)

Number of Non-responders (NR) [Time Frame: Week 48]

Number of Participants With Partial Clinical Response (PCR) [Time Frame: Week 48]

Number of Participants With Major Clinical Response (MCR) [Time Frame: Week 48]

Secondary Outcome(s)

Time Adjusted Mean SLEDAI-2K Score [Time Frame: Week 48]

Number of Participants Who Achieved a BILAG Score of C or Better at Week 24. [Time Frame: Week 24]

Number of Participants Who Achieved A MCR At Week 48, Who Did Not Experience A Flare Before Week 72 [Time Frame: Week 48 to Week 72]

Number of Participants Who Achieved A Major Or Partial Clinical Response At Week 48 (PCR Plus MCR Proportion), Who Did Not Experience A Flare Before Week 96 [Time Frame: Week 48 to Week 96]

Number of Participants With Adverse Events [Time Frame: Up to 2.5 years]

Change In FACIT-Fatigue Assessment From Baseline To Week 48 [Time Frame: Baseline, Week 48]

Number of Participants Achieved A MCR At Week 48, Who Did Not Experience A Flare Before Week 96 [Time Frame: Week 48 to Week 96]

Time to First Moderate to Severe Flare [Time Frame: Week 48 to Week 96]

Change From Baseline In Pain Quality And Impact Of Pain On Daily Function Measured By The Brief Pain Inventory Short Form At Week 48 [Time Frame: Baseline, Week 48]

Annualized Flare Rate [Time Frame: Week 48 to Week 96]

Change in SF-36 Subscale And Summary Scores From Baseline At Week 48 [Time Frame: Baseline, Week 48]

The EQ-5D Single Index Utility Score At Week 48 [Time Frame: Baseline, Week 48]

Secondary ID(s)

ACT4071g

WA20499

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Roche Pharma AG

Results

• Results available: Yes
• Date Posted: 17/09/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00539838