Trial record 1 of 1 for: NCT00624338

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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

Tracking Information

First Received Date ^ICMJE

February 15, 2008

Last Updated Date

January 10, 2013

Start Date ^ICMJE

February 2008

Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00624338 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus

Official Title ^ICMJE

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)

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Systemic 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.

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.
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 Arm (s)

Experimental: 1
Intervention: Drug: Atacicept 75mg
Experimental: 2
Intervention: Drug: Atacicept 150mg
Placebo Comparator: 3
Intervention: Other: Placebo Comparator

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

461

Completion Date

October 2012

Primary Completion Date

April 2012 (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
History of demyelinating disease or optic neuritis

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT Number ^ICMJE

NCT00624338

Other Study ID Numbers ^ICMJE

27646

Has Data Monitoring Committee

Not Provided

Responsible Party

EMD Serono

Study Sponsor ^ICMJE

EMD Serono

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Daiana Licu, MD

Merck Serono SA - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany

Information Provided By

EMD Serono

Verification Date

January 2013

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

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