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A Rheumatoid Arthritis (RA) Study Treating Signs and Symptoms of RA in People With RA & Receiving Methotrexate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00038298
Recruitment Status : Completed
First Posted : May 31, 2002
Last Update Posted : January 21, 2011
Sponsor:
Information provided by:
Amgen

Tracking Information
First Submitted Date  ICMJE May 29, 2002
First Posted Date  ICMJE May 31, 2002
Last Update Posted Date January 21, 2011
Study Start Date  ICMJE April 2002
Actual Primary Completion Date May 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2008)
AMG 719 has a favorable safety profile in subjects with RA receiving methotrexate. [ Time Frame: Week 24 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00038298 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2008)
To assess the effects of multiple doses of AMG 719 relative to placebo on signs and symptoms of RA [ Time Frame: Week 24 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE A Rheumatoid Arthritis (RA) Study Treating Signs and Symptoms of RA in People With RA & Receiving Methotrexate
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Assess the Efficacy, Safety and Tolerability of AMG 719 in Subjects With Rheumatoid Arthritis Receiving Methothrexate
Brief Summary This clinical study is investigating AMG 719, an investigational drug, for the treatment of patients who have Rheumatoid Arthritis and who are taking Methotrexate. AMG 719 is a drug which is self-injected beneath the skin (similarly to the way insulin is self-injected by diabetics). Patients on this study are on study for 28-weeks. They visit the study facility at least 11 times while participating in the study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: Placebo
    Placebo given 3 times weekly
  • Drug: AMG 719
    50 mg 3 times weekly
  • Drug: AGM 719
    200 mg 3 times weekly
  • Drug: AMG 719
    400 mg 3 times weekly
  • Drug: placebo to AMG 719
    Placebo dose given 3 times weekly
Study Arms
  • Experimental: 50 mg
    50 mg 3 times weekly
    Intervention: Drug: AMG 719
  • Experimental: 400 mg
    400 mg 3 times weekly
    Intervention: Drug: AMG 719
  • Experimental: 200 mg
    200 mg 3 times weekly
    Intervention: Drug: AGM 719
  • Placebo Comparator: Placebo
    Placebo comparator associated with each active arm. (3:1 active vs placebo)
    Interventions:
    • Drug: Placebo
    • Drug: placebo to AMG 719
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2008)
53
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date May 2004
Actual Primary Completion Date May 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • Men or women, at least 18 years of age at screening
  • Diagnosed with Rheumatoid Arthritis, with a disease duration of at least 24 weeks, receiving methotrexate, and having no recent history of substance or alcohol abuse
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00038298
Other Study ID Numbers  ICMJE 20010238
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Global Development Leader, Amgen Inc.
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP