Study of Atacicept in Anti-TNFα-naïve Patients With Moderate to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate

This study has been completed.
Information provided by (Responsible Party):
EMD Serono Identifier:
First received: January 7, 2008
Last updated: August 23, 2011
Last verified: August 2011
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 RA, inadequate response to methotrexate (MTX) and no previous exposure to anti-TNFα therapy

Condition Intervention Phase
Rheumatoid Arthritis
Drug: Atacicept
Other: Placebo
Biological: Humira
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo Controlled, Multi-centre Phase II Study of Atacicept in Anti-TNFα-naïve Patients With Moderate to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Resource links provided by NLM:

Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • The proportion of subjects achieving an ACR20 response at Week 26. [ Time Frame: Approximately Monthly ] [ Designated as safety issue: No ]

Enrollment: 311
Study Start Date: September 2007
Study Completion Date: August 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: Atacicept
Atacicept 150 mg tiw for 4 weeks, qw weeks 5 thru 25
Experimental: 2
Atacicept alternating with placebo
Drug: Atacicept
Atacicept 150 mg qw weeks 1 thru 25
Placebo Comparator: 3
Other: Placebo
Placebo qw weeks 1 thru 25
Active Comparator: 4
Biological: Humira
Humira 40 mg eow


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female subjects ≥ 18 years of age at the time of Informed Consent who have rheumatoid arthritis satisfying American College of Rheumatology criteria and a disease history of at least 6 months.
  • Subjects must have active disease, defined by ≥ 8 swollen joints (out of 66), ≥ 8 tender joints (out of 68) and CRP ≥ 10mg/L and/or ESR ≥ 28 mm/hr, despite treatment with methotrexate (MTX) at a dose of ≥ 15 mg/week for > 3 months

Exclusion Criteria:

  • Inflammatory joint disease other than RA.
  • Previous or concurrent treatment with any approved or investigational biological compound for RA,including but not restricted to any anti-TNFα agents, rituximab, abatacept, tocilizumab, interleukin-1 receptor antagonist (IL-1Ra) and belimumab.
  • Treatment with DMARDs other than MTX
  • Participation in any interventional clinical trial within 1 month before SD1
  • Methotrexate dose > 25 mg/week, prednisone dose >10 mg/day (or equivalent), or change in steroid or NSAID dosing regimen within 28 days before SD 1.
  • Live vaccine or Ig treatment within 28 days before SD 1 or need for such treatment during the study (including follow-up).
  • Any history or presence of active or latent tuberculosis, major infection requiring hospitalisation or intravenous anti-infectives within 28 days before SD 1.
  • Other major concurrent illness or organ dysfunction.
  • Serum IgG below 6 g/L.
  • Known hypersensitivity to atacicept or to any of the components of the formulated atacicept.
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Please refer to this study by its identifier: NCT00595413

United States, Massachusetts
Rockland, Massachusetts, United States, 02370
Sponsors and Collaborators
EMD Serono
Study Director: Nils Kinnman Merck Serono International SA, an affiliate of Merck KGaA Darmstadt, Germany
  More Information

Additional Information:
No publications provided by EMD Serono

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: EMD Serono Identifier: NCT00595413     History of Changes
Other Study ID Numbers: 27905  2007-002536-29 
Study First Received: January 7, 2008
Last Updated: August 23, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on February 09, 2016