A Rheumatoid Arthritis (RA) Study Treating Signs and Symp... | NCT00038298

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

NCT00038298

Sponsor

Amgen

Status

Completed

Last Update Posted

Jan 21, 2011Estimated

Enrollment

53Actual

Phase

Phase 2

Conditions

Rheumatoid Arthritis

Interventions

Placebo
AMG 719
AGM 719
AMG 719
placebo to AMG 719

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2002

Primary Completion Date

May 2004Actual

Completion Date

May 2004Actual

First Submitted Date

May 29, 2002

First Submission Date that Met QC Criteria

May 30, 2002

First Posted Date

May 31, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2011

Last Update Posted Date

Jan 21, 2011Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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: Placebo Drug: placebo to AMG 719

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo given 3 times weekly	Placebo
AMG 719

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AMG 719 has a favorable safety profile in subjects with RA receiving methotrexate.		Week 24

Secondary Outcomes

Measure	Description	Time Frame
To assess the effects of multiple doses of AMG 719 relative to placebo on signs and symptoms of RA		Week 24

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
MD	Amgen	Study Director

Label	URL
AmgenTrials clinical trials website	View source

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided