Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Phase II Dose-finding Study of Atacicept in Rheumatoid Arthritis (RA) (August I)

This study has been completed.
Sponsor:
Collaborator:
ZymoGenetics
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT00430495
First received: January 30, 2007
Last updated: August 23, 2011
Last verified: August 2011
  Purpose

D-blind, placebo-controlled, parallel-arm, multicentre, prospective dose-finding trial of the safety and efficacy of atacicept in subjects with active rheumatoid arthritis who have failed a three month therapeutic trial with a TNFa antagonist due to lack of efficacy.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Atacicept
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multicentre, Phase II Dose-finding Study of Atacicept Given Subcutaneously in Subjects With Rheumatoid Arthritis and Inadequate Response to TNFa Antagonist Therapy

Resource links provided by NLM:


Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • Primary is functional status or ACR 20 at week 26. Interval measurments are performed at monthly visits. [ Time Frame: At week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportions of subjects achieving: ACR50 and ACR70 responses, a DAS 28 of 3.2 or less, or subjects with an improvement in the HAQ Disability Index of at least 0.3 from baseline [ Time Frame: At 26 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 288
Study Start Date: December 2006
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Atacicept 25mg
Drug: Atacicept
SC for injection twice weekly for 4 weeks, then once weekly for 21 weeks
Experimental: 2
Atacicept 75mg
Drug: Atacicept
SC for injection twice weekly for 4 weeks, then once weekly for 21 weeks
Experimental: 3
Atacicept 150mg
Drug: Atacicept
SC for injection twice weekly for 4 weeks, then once weekly for 21 weeks
Placebo Comparator: 4
Matching placebo
Drug: Atacicept
SC for injection twice weekly for 4 weeks, then once weekly for 21 weeks

  Eligibility

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

Inclusion Criteria:

  1. Rheumatoid arthritis satisfying YEAR American College of Rheumatology (ACR) Diagnostic Criteria with a disease history of at least one year.
  2. Male or female greater than or equal to 18 years of age at time of Informed Consent.
  3. Active RA as defined by:

    • greater than or equal to swollen joints (66-joint count),
    • greater than or equal to tender joints (68-joint count), and
    • CRP greater than or equal to 10 mg/L (central laboratory) and/or ESR greater than or equal to 28mm/h.
  4. Failure of at least one TNFa antagonist therapy (previously or at the time of screening)

Exclusion Criteria:

  1. Any condition, including laboratory findings or findings in the medical history or pre-trial assessments, that in the opinion of the Investigator constitutes a risk or a contraindication for the subject's participation in the trial or that could interfere with the trial objectives, conduct or evaluation.
  2. Treatment with biologics aiming at B cell modulation such as rituximab (also called Rituxan), a cancer and arthritis drug) or belimumab within 2 years before SD 1.
  3. Any previous treatment with anakinra (Kineret), abatacept (Orencia) or tocilizumab within 3 months before SD1.
  4. Use of etanercept (Enbrel) within 28 days before SD 1, or of infliximab (Remicade) or adalimumab (Humira) within 60 days before SD 1.
  5. Participation in any interventional clinical trial with an unapproved investigational therapy within the 3 months before the start of this study (or within 5 half-lives of the investigated compound before study day 1, whichever is longer).

    • Children are necessarily excluded from this study.
  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: NCT00430495

Locations
United States, Massachusetts
EMD Serono
Rockland, Massachusetts, United States, 02370
Canada
Merck/Serono
Canada, Canada
Sponsors and Collaborators
EMD Serono
ZymoGenetics
Investigators
Study Chair: Nils Kinnman, MD, PhD Merck Serono International S.A. an affiliate of Merck KGaA, Darmstadt, Germany
  More 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: NCT00430495     History of Changes
Other Study ID Numbers: 27298
Study First Received: January 30, 2007
Last Updated: August 23, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 20, 2014