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

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ClinicalTrials.gov Identifier: NCT00293826
Recruitment Status : Completed
First Posted : February 20, 2006
Last Update Posted : March 5, 2010
Sponsor:
Information provided by:
Amgen

Brief Summary:
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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: AMG 108 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 813 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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.
Study Start Date : March 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. ACR20 response [ Time Frame: 24 Weeks ]

Secondary Outcome Measures :
  1. Change in subject reported outcomes [ Time Frame: 24 Weeks ]
  2. ACRn, AUC ACRn, ACR50, ACR70, and DAS28 [ Time Frame: 24 Weeks ]
  3. PK parameters [ Time Frame: 24 Weeks ]
  4. Safety endpoints including AEs, SAEs, SIEs, and change in anti-AMG 108 antibody status [ Time Frame: 24 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00293826


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
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
First Posted: February 20, 2006    Key Record Dates
Last Update Posted: March 5, 2010
Last Verified: March 2010

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