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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
  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:


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: 1007
Study Start Date: January 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 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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Alabama
Division of Clinical Immunology and Rheumatology - UAB
Birmingham, Alabama, United States, 35249-7201
United States, California
Stanford University
Palo Alto, California, United States
Research Site
San Diego, California, United States
Inland Rheumatology Clinical Trials Inc
Upland, California, United States
United States, Florida
Research Site
Jacksonville, Florida, United States
United States, Idaho
Research Site
Boise, Idaho, United States
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
US Local Medical Information
Rockland, Massachusetts, United States, 02370
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
Justus J. Fiechtner, MD, MPH
Lansing, Michigan, United States, 48910
United States, New York
SUNY Health Science Center at Brooklyn
Brooklyn, New York, United States
Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
Hospital for Special Surgey
New York, New York, United States, 10021
Research Site
New York, New York, United States
United States, Ohio
University of Cincinnati Medical Center, Division of Immunology
Cincinnati, Ohio, United States
Research Site
Cincinnati, Ohio, United States
United States, Texas
Research Site
Temple, Texas, United States
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States
Argentina
Research Site
Buenos Aires, Argentina
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Cordoba, Argentina
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Quilmes, Argentina
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San Juan, Argentina
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Tucuman, Argentina
Australia
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Cairns, Australia
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Clayton, Victoria, Australia
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Sunshine Coast, Queensland, Australia
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Woodville S.A., Australia
Austria
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Wein, Austria
Bulgaria
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Sofia, Bulgaria
Croatia
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Osijek, Croatia
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Rijeka, Croatia
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Split, Croatia
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Zagreb, Croatia
Czech Republic
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Prague, Czech Republic
France
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Bordeaux Pessac, France
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Lille, France
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Montpelier Cedex, France
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Paris, France
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Strasbourg, France
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Toulouse, France
Germany
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Berlin, Germany
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Erlangen, Germany
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Hanover, Germany
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Heidelberg, Germany
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Herne, Germany
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Munchen, Germany
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Munster, Germany
Greece
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Athens, Greece
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Thessaloniki, Greece
India
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Secunderabad, Andhra Pradesh, India
Israel
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Haifa, Israel
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Jerasalem, Israel
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Petah-Tikva, Israel
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Tel Aviv, Israel
Korea, Republic of
Research Site
Gyeonggi-do, Korea, Republic of
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Seoul, Korea, Republic of
Latvia
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Riga, Latvia
Lebanon
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Beirut, Lebanon
Lithuania
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Kaunas, Lithuania
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Vilnius, Lithuania
Malaysia
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Kuala Lumpur, Malaysia
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Perak, Malaysia
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Seremban, Malaysia
Mexico
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Guadalajara Jalisco, Mexico
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Tijuana, BC, Mexico
Netherlands
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Amsterdam, Netherlands
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Leiden, Netherlands
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Maastricht, Netherlands
Philippines
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Angeles City, Pampanga, Philippines
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Davao, Philippines
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Iloilo, Philippines
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Las Pinas, Philippines
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Manila, Philippines
Poland
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Bialystok, Poland
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Gdańsk, Poland
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Krakow, Poland
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Lublin, Poland
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Szczecin, Poland
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Torun, Poland
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Warsawa, Poland
Russian Federation
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Kemerovo, Russian Federation
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Petrozavodsk, Russian Federation
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Ryazan, Russian Federation
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Saratov, Russian Federation
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St Petersburg, Russian Federation
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Tula, Russian Federation
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Yaroslavl, Russian Federation
Serbia
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Belgrade, Serbia
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Niska Banja, Serbia
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Novi Beograd, Serbia
South Africa
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Cape Town, South Africa
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Durban, South Africa
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Panorama, Western Cape, South Africa
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Parlow, Western Cape, South Africa
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Pinelands, South Africa
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Stellenbosch, Western Cape, South Africa
Spain
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Barcelona, Spain
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Madrid, Spain
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Malaga, Spain
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Santiago de Compostela, Spain
Switzerland
Research Site
St. Gallen, Switzerland
Taiwan
Research Site
Taichung, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taoyuan, Taiwan
Ukraine
Research Site
Donetsk, Ukraine
Research Site
Kharkiv, Ukraine
Research Site
Kyiv, Ukraine
Research Site
Lviv, Ukraine
Research Site
Ternopil, Ukraine
Research Site
Vinnytsya, Ukraine
Research Site
Zhytomyr, Ukraine
United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Medical Responsible Merck KGaA
  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: October 21, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014