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.
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT00595413
First received: January 7, 2008
Last updated: August 23, 2011
Last verified: August 2011
  Purpose

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
Atacicept
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
Placebo
Other: Placebo
Placebo qw weeks 1 thru 25
Active Comparator: 4
Humira
Biological: Humira
Humira 40 mg eow

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00595413

Locations
United States, Massachusetts
Rockland, Massachusetts, United States, 02370
Sponsors and Collaborators
EMD Serono
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: EMD Serono
ClinicalTrials.gov 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
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Adalimumab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 17, 2014