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Terminated Phase 2 Interventional Results available

Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II)

ClinicalTrials.gov ID: NCT02070978

Public ClinicalTrials.gov record NCT02070978. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 1:47 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a multicenter, double-blind, Phase 2b, long-term extension (LTE) to the ADDRESS II core trial (EMR 700461-023) (NCT01972568), to evaluate long-term safety and tolerability of atacicept in participants with systemic lupus erythematosus (SLE). Participants who completed the 24-week core study ADDRESS II core study (NCT01972568) and thus not met any of the discontinuation criteria were invited to enter this long-term extension (LTE) study NCT02070978.

Study identification

NCT ID
NCT02070978
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2
Lead sponsor
EMD Serono
Industry
Enrollment
253 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 29, 2014 (Actual)
Primary completion
Apr 5, 2016 (Actual)
Completion
Feb 9, 2018 (Actual)
Last update posted
Mar 21, 2019

2014 – 2018

United States locations

U.S. sites
23
U.S. states
14
U.S. cities
20
Facility City State ZIP Site status
Pinnacle Research Group LLC Anniston Alabama 36207 —
University of Alabama at Birmingham - (UAB) Birmingham Alabama 35294 —
Wallace Rheumatic Study Center Beverly Hills California 90211 —
Southern California Permenent Medical Group Fontana California 92335 —
East Bay Rheumatology Medical Group, Inc. San Leandro California 94578 —
Clinical Research of West Florida - Corporate Clearwater Florida 33765 —
Clinical Research of West Florida, Inc. Tampa Florida 33603 —
McIlwain Medical Group, PA Tampa Florida 33613 —
AA MRC LLC Ahmed Arif Medical Research Center Grand Blanc Michigan 48439 —
Mayo Clinic Rochester Minnesota 55905 —
Washington University St Louis Missouri 63110 —
Clayton Medical Associates, P.C. St Louis Missouri 63117 —
Rutgers New Jersey Medical School Newark New Jersey 07103 —
The Feinstein Institute for Medical Research Manhasset New York 11031 —
Hospital for Special Surgery New York New York 10021 —
DJL Clinical Research, PLLC Charlotte North Carolina 28210 —
MetroHealth System Cleveland Ohio 44109 —
Arthritis & Rheumatology Center of Oklahoma Oklahoma City Oklahoma 73103 —
OMRF Oklahoma City Oklahoma 73104 —
Clinical Research Center of Reading LLC Wyomissing Pennsylvania 19610 —
Medical University of South Carolina (MUSC) Charleston South Carolina 29425 —
Austin Regional Clinic, P.A. Austin Texas 78731 —
Little River Arthritis & Osteoporosis Clinic Waco Texas 76708 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 61 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02070978, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 21, 2019 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02070978 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →