Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II)
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.
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
- Enrollment
- 253 participants
Conditions and interventions
Conditions
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 28, 2014
- Primary completion
- Apr 4, 2016
- Completion
- Feb 8, 2018
- Last update posted
- Mar 20, 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 20, 2019 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02070978 live on ClinicalTrials.gov.