AMG 827 in Rheumatoid Arthritis Subjects With Inadequate Response to Methotrexate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00950989
First received: July 30, 2009
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

Randomized, double-blind, placebo-controlled study in subjects with RA who have an inadequate response to methotrexate.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: AMG 827 70 mg
Drug: AMG 827 140 mg
Drug: AMG 827 210 mg
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • To evaluate the efficacy of AMG 827 compared with placebo as measured by the proportion of subjects achieving an American College of Rheumatology (ACR) 50 response at week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the efficacy of AMG 827 as measured by the following: The proportion of subjects with an ACR 20 and 70 at week 12 and Disease Activity Score 28 joint (DAS28) at week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To evaluate the short term safety profile of AMG 827 in subjects with rheumatoid arthritis (RA) [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • To characterize the pharmacokinetics (PK) of AMG 827 in subjects with Rheumatoid Arthritis (RA) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: December 2009
Study Completion Date: April 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 827 210 mg
210 mg AMG 827
Drug: AMG 827 210 mg
210 mg AMG 827 SC + stable weekly dose of methotrexate
Experimental: AMG 827 140 mg
140 mg AMG 827
Drug: AMG 827 140 mg
140 mg AMG 827 SC + stable weekly dose of methotrexate
Experimental: AMG 827 70 mg
70mg AMG 827
Drug: AMG 827 70 mg
70 mg AMG 827 SC + stable weekly dose of methotrexate
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo SC + stable weekly dose of methotrexate

  Eligibility

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

Inclusion Criteria:

  • Active RA for least 6 months
  • Current RA defined as ≥ 6 swollen joints (out of 66 joints examined) and ≥ 8 tender/painful joints (out of 68 joints examined) at screening and baseline (swollen and tender/painful joint count must not include distal interphalangeal joints) and at least 1 of the following at screening: Erythrocyte sedimentation rate ≥ 28 mm or C-reactive protein > 15 mg/L
  • At least 1 of the following at screening: Rheumatoid factor positive or Anti-cyclic citrullinated peptide antibody positive
  • Currently taking methotrexate for ≥ 12 weeks and on a stable dose of methotrexate at 15 to 25 mg weekly for ≥ 4 weeks at day -1.

Exclusion Criteria:

  • Prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening
  • Class IV RA
  • Felty's syndrome
  • Presence of serious infection
  • Significant concurrent medical conditions
  • Pregnant or breast feeding
  • Significant Laboratory abnormalities
  • Any DMARD other than methotrexate within 28 days
  • Leflunomide or live vaccines within 3 months
  • Previous use of any experimental or commercially available biologic DMARD
  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: NCT00950989

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

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00950989     History of Changes
Other Study ID Numbers: 20090061
Study First Received: July 30, 2009
Last Updated: January 14, 2014
Health Authority: Bulgaria: Ministry of Health
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Latvia: State Agency of Medicines
Mexico: Ministry of Health
Poland: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Amgen:
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

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

ClinicalTrials.gov processed this record on July 26, 2014