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AMG 827 in Rheumatoid Arthritis Subjects With Inadequate Response to Methotrexate

This study has been completed.
Information provided by (Responsible Party):
Amgen Identifier:
First received: July 30, 2009
Last updated: September 1, 2016
Last verified: August 2016
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
Drug: Stable weekly dose of methotrexate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 ]

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 ]
  • To evaluate the short term safety profile of AMG 827 in subjects with rheumatoid arthritis (RA) [ Time Frame: 16 weeks ]
  • To characterize the pharmacokinetics (PK) of AMG 827 in subjects with Rheumatoid Arthritis (RA) [ Time Frame: 16 weeks ]

Enrollment: 240
Study Start Date: December 2009
Study Completion Date: February 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
Drug: Stable weekly dose of methotrexate
Experimental: AMG 827 140 mg
140 mg AMG 827
Drug: AMG 827 140 mg
140 mg AMG 827 SC
Drug: Stable weekly dose of methotrexate
Experimental: AMG 827 70 mg
70mg AMG 827
Drug: AMG 827 70 mg
70 mg AMG 827 SC
Drug: Stable weekly dose of methotrexate
Placebo Comparator: Placebo
Drug: Placebo
Placebo SC
Drug: Stable weekly dose of methotrexate


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00950989

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen Identifier: NCT00950989     History of Changes
Other Study ID Numbers: 20090061
Study First Received: July 30, 2009
Last Updated: September 1, 2016

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

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors processed this record on May 22, 2017