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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT00624338
First received: February 15, 2008
Last updated: October 21, 2013
Last verified: October 2013

February 15, 2008
October 21, 2013
January 2008
April 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00624338 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus
A 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)

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Systemic Lupus Erythematosus, SLE
  • 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.

    The atacicept 150mg has been discontinued. The decision was taken following a recommendation of the Independent Data Monitoring Committee. They determined that the risk benefit profile for the patients receiving the higher dose of Atacicept was unfavorable.

  • 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.
  • Experimental: 1
    Intervention: Drug: Atacicept 75mg
  • Experimental: 2
    Intervention: Drug: Atacicept 150mg
  • Placebo Comparator: 3
    Intervention: Other: Placebo Comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1007
October 2012
April 2012   (final data collection date for primary outcome measure)

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
  • History of demyelinating disease or optic neuritis
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United 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
 
NCT00624338
27646
Not Provided
EMD Serono
EMD Serono
Not Provided
Study Director: Medical Responsible Merck KGaA
EMD Serono
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP