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Completed

NCT Number: NCT00293826

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AMG 108

Drug

50mg via SC (subcutaneous) injection every 4 weeks

Placebo

Drug

Placebo via SC (subcutaneous) injection every 4 weeks

Primary outcomes

  1. ACR20 response

    Time frame: 24 Weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Feb 20, 2006
Registry last updated
Mar 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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