Has mgt. guided in recent CCs when Atacicept PIII results are expected?

According to ClinicalTrials.gov results are due Q1 2011 (anyone know otherwise???):

http://clinicaltrials.gov/ct2/show/NCT00624338?term=atacicept&rank=4

Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus (April SLE)
This study is currently recruiting participants.
Verified by EMD Serono, August 2009
First Received: February 15, 2008 Last Updated: August 18, 2009 History of Changes
Sponsor: EMD Serono
Information provided by: 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 II
Phase III



Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
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: February 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental 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.
2: Experimental 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.
3: Placebo Comparator 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
Contacts and Locations

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


Contacts
Contact: Ellen Rotty, BSN +1-781-681-2889 ellen.rotty@emdserono.com

Show 99 Study Locations

Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Claudia Pena Rossi, MD, PhD Merck Serono SA - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany

More Information

No publications provided

Responsible Party: Merck Serono SA - Geneva an affiliate of Merck KGaA, Darmstadt, Germany ( Claudia Pena Rossi, MD, PhD, Medical Director )
Study ID Numbers: 27646
Study First Received: February 15, 2008
Last Updated: August 18, 2009
ClinicalTrials.gov Identifier: NCT00624338 History of Changes
Health Authority: United States: Food and Drug Administration

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



ClinicalTrials.gov processed this record on November 01, 2009