Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus

Completed · Phase 3

Conditions studied: Systemic Lupus Erythematosus

In brief

The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)

Key facts

Study ID

NCT01408576

Run by

UCB Pharma

People needed

1250

Starts

2011-07-01

Expected to finish

2016-02-01

Last updated by the study team

2018-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has completed the double-blind study SL0009 (NCT01262365) or SL0010 (NCT01261793) or terminated prematurely at Week 16 or later in SL0009 or SL0010 due to lack of efficacy and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment
• Subject has completed open-label study SL0006 (NCT00383513) or SL0008 (NCT00660881), and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment
• Women of childbearing potential must agree to use an acceptable method of birth control

You may not qualify if…

• Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring British Isles Lupus Assessment Group Index (BILAG) level A disease
• Subjects with active, severe SLE disease activity which involves the renal system
• Subjects with concurrent relevant medical conditions like defined chronic infections or high risk of new significant infections
• Substance abuse or dependence
• History of malignant cancer
• Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion

Where it is running

• 557 — Little Rock, Arkansas, United States
• 515 — Hemet, California, United States
• 544 — Huntington Beach, California, United States
• 550 — La Jolla, California, United States
• 031 — Los Angeles, California, United States
• 051 — Los Angeles, California, United States
• 089 — Los Angeles, California, United States
• 531 — San Leandro, California, United States
• 594 — Thousand Oaks, California, United States
• 558 — Torrance, California, United States
• 048 — Aurora, Colorado, United States
• 037 — Colorado Springs, Colorado, United States
• 532 — Denver, Colorado, United States
• 511 — Bridgeport, Connecticut, United States
• 039 — Farmington, Connecticut, United States
• 042 — Aventura, Florida, United States
• 514 — Brandon, Florida, United States
• 090 — Clearwater, Florida, United States
• 092 — DeBary, Florida, United States
• 533 — Fort Lauderdale, Florida, United States
• 064 — Jupiter, Florida, United States
• 070 — Ormond Beach, Florida, United States
• 084 — Palm Harbor, Florida, United States
• 518 — Plantation, Florida, United States
• 539 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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