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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: January 10, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Systemic Lupus Erythematosus, SLE
 Drug: Atacicept 75mg
Drug: Atacicept 150mg
Other: Placebo Comparator
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

MedlinePlus related topics: Lupus
U.S. FDA Resources

Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 461
Study Start Date: February 2008
Study Completion Date: October 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.
Experimental: 2 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 Atacicpet 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.
Placebo Comparator: 3 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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00624338

  Show 113 Study Locations
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Daiana Licu, MD Merck Serono SA - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany
  More Information

No publications provided

Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00624338     History of Changes
Other Study ID Numbers: 27646
Study First Received: February 15, 2008
Last Updated: January 10, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 18, 2013