Back to resultsA Rheumatoid Arthritis (RA) Study Treating Signs and Symptoms of RA in People With RA & Receiving Methotrexate
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Placebo
AMG 719
AGM 719
AMG 719
placebo to AMG 719
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
50 mg
400 mg
200 mg
Placebo
Arm Description
50 mg 3 times weekly
400 mg 3 times weekly
200 mg 3 times weekly
Placebo comparator associated with each active arm. (3:1 active vs placebo)
Outcomes
Primary Outcome Measures
AMG 719 has a favorable safety profile in subjects with RA receiving methotrexate.
Secondary Outcome Measures
To assess the effects of multiple doses of AMG 719 relative to placebo on signs and symptoms of RA
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00038298
Brief Title
A Rheumatoid Arthritis (RA) Study Treating Signs and Symptoms of RA in People With RA & Receiving Methotrexate
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
May 2004 (Actual)
Study Completion Date
May 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
50 mg
Arm Type
Experimental
Arm Description
50 mg 3 times weekly
Arm Title
400 mg
Arm Type
Experimental
Arm Description
400 mg 3 times weekly
Arm Title
200 mg
Arm Type
Experimental
Arm Description
200 mg 3 times weekly
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo comparator associated with each active arm. (3:1 active vs placebo)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo given 3 times weekly
Intervention Type
Drug
Intervention Name(s)
AMG 719
Intervention Description
50 mg 3 times weekly
Intervention Type
Drug
Intervention Name(s)
AGM 719
Intervention Description
200 mg 3 times weekly
Intervention Type
Drug
Intervention Name(s)
AMG 719
Intervention Description
400 mg 3 times weekly
Intervention Type
Drug
Intervention Name(s)
placebo to AMG 719
Intervention Description
Placebo dose given 3 times weekly
Primary Outcome Measure Information:
Title
AMG 719 has a favorable safety profile in subjects with RA receiving methotrexate.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
To assess the effects of multiple doses of AMG 719 relative to placebo on signs and symptoms of RA
Time Frame
Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
URL
http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
Description
Notice regarding posted summaries of trial results
URL
http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_47_AMG_719_20010238.pdf
Description
To access clinical trial results information click on this link
Learn more about this trial
A Rheumatoid Arthritis (RA) Study Treating Signs and Symptoms of RA in People With RA & Receiving Methotrexate
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