Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
EMD Serono
Study ID
NCT00624338
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Lupus Erythematosus, Systemic

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atacicept 75 mg — DRUG
    75 milligram (mg) atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
  • Atacicept 150 mg — DRUG
    150 mg atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
  • Placebo Comparator — OTHER
    Placebo matched to atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.

Study Details

This study is to evaluate the efficacy and safety of atacicept compared to placebo in preventing new flares in subjects with systemic lupus erythematosus (SLE) and to confirm the optimal dose of atacicept for treatment of subjects with SLE and gain information on the effect of atacicept on markers specific to its mechanism of action (MoA) and their correlation to disease activity/progression. Study medication will be administered through subcutaneous (under the skin) injections, beginning with twice weekly injections for the first 4 weeks, followed by once weekly doses for 48 weeks. Following the last treatment, a safety follow-up period of 24 weeks will be conducted.

Key Dates

Start date
Jan 31, 2008
Status verified
Mar 2016
Primary completion
Apr 30, 2012
Completion
Oct 31, 2012

Study Design

Enrollment
461 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Atacicept 75 mg
  • Experimental: Atacicept 150 mg
  • Placebo Comparator: Placebo

Primary Outcome Measure

Percentage of Participants Experiencing a New Flare as Defined by British Isles Lupus Assessment Group (BILAG) Score A or B [ Time Frame: From screening up to Week 52 ]

Locations (18)

FacilityCityStateZIPSite coordinators
Division of Clinical Immunology and Rheumatology - UABBirminghamAlabama35249-7201-
Stanford UniversityPalo AltoCalifornia--
Research SiteSan DiegoCalifornia--
Inland Rheumatology Clinical Trials IncUplandCalifornia--
Research SiteJacksonvilleFlorida--
Research SiteBoiseIdaho--
Brigham and Women's HospitalBostonMassachusetts02115-
US Local Medical InformationRocklandMassachusetts02370-
Wayne State UniversityDetroitMichigan48201-
Justus J. Fiechtner, MD, MPHLansingMichigan48910-
SUNY Health Science Center at BrooklynBrooklynNew York--
Feinstein Institute for Medical ResearchManhassetNew York11030-
Hospital for Special SurgeyNew YorkNew York10021-
Research SiteNew YorkNew York--
Research SiteCincinnatiOhio--
University of Cincinnati Medical Center, Division of ImmunologyCincinnatiOhio--
Research SiteTempleTexas--
Virginia Mason Medical CenterSeattleWashington--

Find similar trials in Birmingham, AL

By research site
Division of Clinical Immunology and Rheumatology - UAB· Birmingham, ALStanford University· Palo Alto, CAResearch Site· San Diego, CAInland Rheumatology Clinical Trials Inc· Upland, CAResearch Site· Jacksonville, FLResearch Site· Boise, ID

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