ong-term safety and tolerability study of atacicept in patients with Systemic Lupus Erythematosus who completed protocol EMR-700461-023 (ADDRESS II)

Phase 1

• Conditions: Systemic Lupus Erythematosus (SLE); MedDRA version: 18.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2013-002758-62-BG
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-01
• Study Completion: 2018-02-09
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 253

Inclusion Criteria

- Subjects who have completed the 24-week treatment period of trial EMR-700461-023 (ADDRESS II core trial).
- Women of childbearing potential (WOCBP) who have a negative pregnancy test
- Other protocol defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 202
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11

Exclusion Criteria

- Active neurological symptoms of SLE that are deemed severe or progressive
- Diagnosis of any demyelinating disease, such as, but not restricted to, MS or optic neuritis
- Pregnancy
- Other protocol defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified