Trial record 3 of 3 for:    amg 827 | "Rheumatic Diseases"

Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00771030
First received: October 9, 2008
Last updated: January 20, 2011
Last verified: January 2011
  Purpose

This Phase 1b/2a study will evaluate safety, tolerability PK and PD of AMG 827 when administered in multiple SC and IV doses in patients with active rheumatoid arthritis in combination with a stable dose of DMARDs. Part A is dose escalation (to assess safety & tolerability), and Part B is dose expansion (to assess clinical efficacy) at the highest tolerated dose level of AMG 827 from Part A.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: AMG 827
Phase 1
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, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Part B:Primary efficacy outcome is the bdACR Hybrid response in active or placebo groups [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety & tolerability: 1. treatment-emergent AE(s) 2. clinically significant changes in safety labs, PE, vital signs and 3. development of anti-AMG 827 antibodies. [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: November 2008
Study Completion Date: July 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arthritis, rheumatoid
Part A - Dose escalation Part B - Dose expansion
Drug: AMG 827
Five treatment dose levels plus placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female between 18 to 70 years of age, inclusive at the time of screening
  • Diagnosed with active RA (class 1-3) for at least 6 months as determined by meeting ACR 1987 revised classification criteria.
  • Additional Inclusion Criteria Apply

Exclusion Criteria:

  • History or evidence of a clinically significant disorder other than RA (including but not limited to cardiopulmonary, oncologic, renal, metabolic, hematologic or psychiatric), condition or disease that, in the opinion of the Investigator and Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
  • Uncontrolled, clinically significant systemic disease other than RA such as diabetes mellitus, liver disease, asthma, cardiovascular disease or hypertension
  • Malignancy within 5 years (except successfully treated in situ cervical cancer or squamous or basal cell carcinoma of the skin)
  • Presence of a serious or chronic infections
  • Subject (male or female) is not willing to use highly effective contraception, defined as a double barrier method (ie, spermicidal jelly and condom, or condom and diaphragm) during treatment and up to EOS
  • Additional Exclusion Criteria Apply
  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: NCT00771030

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00771030     History of Changes
Other Study ID Numbers: 20070264
Study First Received: October 9, 2008
Last Updated: January 20, 2011
Health Authority: Canada: Institutional Review Board
Mexico: Ministry of Health
United States: Food and Drug Administration
United States: Institutional Review Board
United States: Quorom Institutional Review Board
Canada: Health Canada

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

ClinicalTrials.gov processed this record on August 28, 2014