NCT00038298

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at below P25 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Apr 2002

Typical duration for phase_2 rheumatoid-arthritis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 31, 2002

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
Last Updated

January 21, 2011

Status Verified

January 1, 2011

Enrollment Period

2.1 years

First QC Date

May 29, 2002

Last Update Submit

January 20, 2011

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • AMG 719 has a favorable safety profile in subjects with RA receiving methotrexate.

    Week 24

Secondary Outcomes (1)

  • To assess the effects of multiple doses of AMG 719 relative to placebo on signs and symptoms of RA

    Week 24

Study Arms (4)

50 mg

EXPERIMENTAL

50 mg 3 times weekly

Drug: AMG 719

400 mg

EXPERIMENTAL

400 mg 3 times weekly

Drug: AMG 719

200 mg

EXPERIMENTAL

200 mg 3 times weekly

Drug: AGM 719

Placebo

PLACEBO COMPARATOR

Placebo comparator associated with each active arm. (3:1 active vs placebo)

Drug: PlaceboDrug: placebo to AMG 719

Interventions

PlaceboDRUG

Placebo given 3 times weekly

Placebo
AMG 719DRUG

50 mg 3 times weekly

50 mg
AGM 719DRUG

200 mg 3 times weekly

200 mg
placebo to AMG 719DRUG

Placebo dose given 3 times weekly

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 29, 2002

First Posted

May 31, 2002

Study Start

April 1, 2002

Primary Completion

May 1, 2004

Study Completion

May 1, 2004

Last Updated

January 21, 2011

Record last verified: 2011-01