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: 17.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2013-002758-62-ES

Lead Sponsor: Merck KGaA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 213

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Determine the long-term safety and tolerability of atacicept in SLE subjects.;Secondary Objective: 1. Evaluate the effect of atacicept on changes in disease activity over time.<br>2. Evaluate the effect of atacicept in reducing corticosteroid (CS) usage.<br>3. Evaluate the immunogenicity, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of atacicept.<br>4. Evaluate the effect of atacicept on patient-reported outcomes (PROs).<br>5. Identify potential associations of genetic variations and gene.;Primary end point(s): - Number of subjects reporting at least one SAE during the treatment period.<br>- Number of subjects prematurely discontinuing the treatment due to AE.;Timepoint(s) of evaluation of this end point: Continuous throughout treatment period up to week 96

Secondary Outcome Measures