Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus - Full Text View

Sponsor:	EMD Serono
Information provided by (Responsible Party):	EMD Serono
ClinicalTrials.gov Identifier:	NCT00624338

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 ]

Estimated Enrollment:	510
Study Start Date:	February 2008
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	May 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 unfavourable.
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:	December 21, 2011
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 May 22, 2012