Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II)
A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed Protocol EMR-700461-023 (ADDRESS II)
Sponsor: EMD Serono
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Number of Participants With at Least One Serious Adverse Event (SAE) During the Treatment Period
Time frame: Baseline (LTE Day 1) up to maximum treatment duration of 143.7 weeks
Number of Participants Who Prematurely Discontinued the Treatment Due to Adverse Event (AE)
Time frame: Baseline (Day 1 of Core study) up to maximum duration of 167.7 weeks
Secondary Endpoints
Change From Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Organ Damage Scores
Change From Baseline in Disease Activity as Measured by British Isles Lupus Assessment Group (BILAG) 2004 Score
Change From Baseline in Disease Activity as Measured by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score
Eligibility Criteria
Inclusion Criteria: * Participants who had completed the 24-week treatment period of study EMR-700461-023 (ADDRESS II core trial) * Women of childbearing potential who had a negative pregnancy test * Other protocol defined inclusion criteria were applied Exclusion Criteria: * Active neurological symptoms of SLE that were deemed severe or progressive * Diagnosis of any demyelinating disease, such as, but not restricted to, multiple sclerosis (MS) or optic neuritis * Pregnancy * Active clinically significant viral, bacterial, or fungal infection, or any major episode of infection that in the investigator's opinion makes the participants unsuitable to continued participation in the study * Other protocol defined exclusion criteria were applied
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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