Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus (April SLE) 


Tracking Information

Start Date  ICMJEFebruary 2008
Estimated Primary Completion DateJanuary 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2008)		Proportion of patients experiencing a new flare as defined by a BILAG score of A or B during the 52 week treatment period [ Time Frame: Measures are monthly for 52 weeks, and at 24 weeks after last dose ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00624338 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: February 15, 2008)		1- Time to new flare after randomization 2- Proportion of patients with new flare within the first 24 weeks after randomization [ Time Frame: Ad hoc and at 24 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEAtacicept Phase II/III in Generalized Systemic Lupus Erythematosus
Official Title  ICMJEA Randomised, Double-blind, Placebo Controlled, Multicentre Prospective Dose-finding Phase II/III Study With Atacicept Given Subcutaneously to Subjects Having Recently Experienced a Flare of Systemic Lupus Erythematosus (SLE)
Brief Summary

This study is intended to evaluate the use of atacicept compared to placebo in reducing the number of flares for people with SLE. The study is randomized and is designed to find the most effective dose of atacicept. Study medication is administered via subcutaneous (under the skin) injections, beginning with twice weekly injections for the first 4 weeks, followed by weekly doses for one year. Follow-up will continue for an additional 24 weeks.

Detailed Description 
Study PhasePhase II, Phase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Condition  ICMJESystemic Lupus Erythematosus, SLE
Intervention  ICMJE
  • Drug: Atacicept 75mg
    Dose is 75mg given subcutaneously (under the skin), twice a week for 4 weeks, and then once a week for 48 weeks.
  • Drug: Atacicept 150mg
    Dose is 150mg given subcutaneously (under the skin), twice a week for 4 weeks, and then once a week for 48 weeks.
  • Other: Placebo Comparator
    Placebo comparator is matched volume given subcutaneously (under the skin), twice a week for 4 weeks, and then once a week for 48 weeks.
Study Arms / Comparison Groups
  • 1: Experimental
    Intervention: Drug: Atacicept 75mg
  • 2: Experimental
    Intervention: Drug: Atacicept 150mg
  • 3: Placebo Comparator
    Intervention: Other: Placebo Comparator

Recruitment Information

Estimated Enrollment  ICMJE510
Estimated Completion DateFebruary 2011
Estimated Primary Completion DateJanuary 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 16 years of age or older
  • Disease history of at least six months meeting at least 4 ACR criteria for SLE
  • BILAG flare A or B at screening requiring a change in corticosteroids
  • a positive ANA or anti-dsDNA at screening
  • Female subjects must be willing to avoid pregnancy

Exclusion Criteria:

  • Active moderate to severe glomerulonephritis (kidney impairment)
  • Active central nervous system SLE deemed to be severe/progressive
  • Previous treatment with rituximab, abatacept, or belimumab
GenderBoth
Ages16 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Ellen Rotty, BSN+1-781-681-2889ellen.rotty@emdserono.com
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Austria,   Bulgaria,   Croatia,   Czech Republic,   France,   Germany,   Greece,   India,   Israel,   Korea, Republic of,   Latvia,   Lebanon,   Lithuania,   Malaysia,   Mexico,   Netherlands,   Philippines,   Poland,   Russian Federation,   Serbia,   South Africa,   Spain,   Switzerland,   Taiwan,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00624338
Responsible PartyClaudia Pena Rossi, MD, PhD, Medical Director, Merck Serono SA - Geneva an affiliate of Merck KGaA, Darmstadt, Germany
Study ID Numbers  ICMJE27646
Study Sponsor  ICMJEEMD Serono
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Claudia Pena Rossi, MD, PhDMerck Serono SA - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany
Information Provided ByEMD Serono