A Multiple Dose Study to Evaluate Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00293826
First received: February 17, 2006
Last updated: March 4, 2010
Last verified: March 2010
  Purpose

The purpose of this study is to determine if AMG 108 in combination with methotrexate is safe and effective in the treatment of rheumatoid arthritis.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: AMG 108
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, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis.

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • ACR20 response [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in subject reported outcomes [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • ACRn, AUC ACRn, ACR50, ACR70, and DAS28 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • PK parameters [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Safety endpoints including AEs, SAEs, SIEs, and change in anti-AMG 108 antibody status [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 813
Study Start Date: March 2006
Study Completion Date: February 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
196 subjects
Drug: AMG 108
50mg via SC (subcutaneous) injection every 4 weeks
Experimental: 3
196 subjects
Drug: AMG 108
250mg via SC (subcutaneous) injection every 4 weeks
Experimental: 2
196 subjects
Drug: AMG 108
125mg via SC (subcutaneous) injection every 4 weeks
Placebo Comparator: 4
196 subjects
Drug: Placebo
Placebo via SC (subcutaneous) injection every 4 weeks

  Eligibility

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

Inclusion Criteria:

  • Subjects with active rheumatoid arthritis as diagnosed by meeting ACR classification criteria for at least 6 months.
  • Must be taking MTX consecutively for >/= 12 weeks and at a stable dose of methotrexate at 15-25 mg weekly for at least 4 weeks prior to screening

Exclusion Criteria:

  • Receipt of commercial or experimental biologic therapies for the treatment of inflammatory disease
  • Presence of serious infection
  • Class IV rheumatoid arthritis
  • Prior or current history of tuberculosis infection or exposure
  • Any other DMARDs other than methotrexate within 6 weeks of screening
  • Pregnant or nursing
  • Receipt of live vaccines within 3 months
  • Felty's syndrome
  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: NCT00293826

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: NCT00293826     History of Changes
Other Study ID Numbers: 20050168
Study First Received: February 17, 2006
Last Updated: March 4, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
ACR criteria
methotrexate
DMARDs
patient reported outcomes
joint assessment

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 September 30, 2014