Atacicept in Anti-Tumor Necrosis Factor Alpha-naïve Subjects With Rheumatoid Arthritis (AUGUST II)

Part of paid clinical trials in Rockland, Massachusetts.

Sponsor
EMD Serono
Study ID
NCT00595413
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Placebo matched to atacicept — DRUG
    Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
  • Atacicept: with loading dose — DRUG
    Atacicept will be administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
  • Atacicept — DRUG
    Atacicept will be administered subcutaneously at a dose of 150 mg once a week for 25 weeks.
  • Adalimumab — BIOLOGICAL
    Adalimumab (Humira®) will be administered subcutaneously at a dose of 40 mg every other week for 25 weeks.

Study Details

The primary objective of this study is to evaluate the efficacy of atacicept compared to placebo in the treatment of signs and symptoms in a subject population with active rheumatoid arthritis (RA), inadequate response to methotrexate (MTX) and no previous exposure to anti-tumor necrosis factor alpha (anti-TNFalpha) therapy.

Key Dates

Start date
Sep 30, 2007
Status verified
Jan 2016
Primary completion
Oct 31, 2009
Completion
Oct 31, 2009

Study Design

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

Arms

  • Experimental: Atacicept 150 mg with loading dose
  • Experimental: Atacicept 150 mg without loading dose
  • Active Comparator: Adalimumab
  • Placebo Comparator: Placebo

Primary Outcome Measure

Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP) at Week 26 [ Time Frame: Week 26 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Please Contact US Medical InformationRocklandMassachusetts--

Find similar trials in Rockland, MA

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Please Contact US Medical Information· Rockland, MA

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