A PHASE IIB, MULTI-CENTER, LONG-TERM EXTENSIONTRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OFATACICEPT IN SUBJECTS WITH SYSTEMIC LUPUSERYTHEMATOSUS (SLE) WHO COMPLETED PROTOCOLEMR-700461-023 (ADDRESS II)
- Conditions
- -M32 Systemic lupus erythematosusSystemic lupus erythematosusM32
- Registration Number
- PER-051-14
- Lead Sponsor
- Merck KGaA,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- 6
1. Subjects have completed the 24-week treatment period of trial EMR-700461-023
(ADDRESS II core trial).
2. Written informed consent must be given before any procedure relating to this extension trial.
Subjects must have read and understood the informed consent form (ICF), must fully
understand the requirements of the trial, and must be willing to comply with all trial visits
and assessments.
3. Women of childbearing potential (WOCBP) must use highly effective methods of
contraception to prevent pregnancy and must agree to continue to practice adequate
contraception for 60 days after the last dose of IMP. For the purposes of this trial, WOCBP
is defined as:
All female subjects after puberty unless they are postmenopausal (defined by
continuous amenorrhea) for at least 2 years or are surgically sterile.
Highly effective contraception is defined as 2 barrier methods (e.g., female
diaphragm and male condoms), 1 barrier method with spermicide, an intrauterine
device, or hormonal contraceptives (e.g., implant or oral). Note that because
mycophenolate affects the metabolism of hormonal contraceptives and may reduce
their effectiveness, women receiving mycophenolate who are using hormonal
contraceptives for birth control should employ an additional contraceptive method
(e.g., barrier method).
4. WOCBP must have a negative urine pregnancy test at the baseline trial visit (Day 1) before
dosing.
1. Have withdrawn during the core trial due to any of the pre-defined criteria for withdrawal
2. Any condition, including any uncontrolled disease state other than SLE, findings in the
laboratory tests, medical history, or other assessments, which, in the opinion of the
investigator or sponsor/designee constitutes an inappropriate risk or a contraindication for
participation in the trial or that could interfere with the trial’s objectives, conduct, or
evaluation
3. Active neurological symptoms of SLE that are deemed severe or progressive and/or are
associated with significant cognitive impairment leading to the inability to provide informed
consent and/or comply with the protocol
4. Active clinically significant viral, bacterial, or fungal infection, or any major episode of
infection that in the investigator’s opinion makes the subject unsuitable to continue
participation in the trial. Vaginal candidiasis, onychomycosis, and genital or oral herpes
simplex virus, considered by the investigator to be sufficiently controlled, would not be
exclusionary.
5. Diagnosis of any demyelinating disease, such as, but not restricted to, MS or optic neuritis
6. Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method