Long-Term Assessment of Safety and Physical Function With... | NCT00369473

Studies
Long-Term Assessment of Safety and Physical Function With AMG 108 in RA

NCT00369473

Sponsor

Amgen

Status

Completed

Last Update Posted

Dec 13, 2016Estimated

Enrollment

690Actual

Phase

Phase 2

Conditions

Rheumatoid Arthritis

Interventions

AMG 108
AMG 108

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

Dec 2016

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

Sep 2006

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Aug 24, 2006

First Submission Date that Met QC Criteria

Aug 24, 2006

First Posted Date

Aug 29, 2006Estimated

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

Dec 9, 2016

Certification/Extension First Submitted that Passed QC Review

Dec 9, 2016

Certification/Extension First Posted Date

Dec 13, 2016Estimated

Last Update Submitted Date

Dec 9, 2016

Last Update Posted Date

Dec 13, 2016Estimated

Description Module

Brief Summary

The purpose of this study is to assess long-term safety of SC AMG 108 in the treatment of RA

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

690Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	350	Drug: AMG 108
2	Experimental	350	Drug: AMG 108

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AMG 108	Drug	125 mg via SC (subcutaneous) injection every 4 weeks	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess long-term safety of AMG 108 SC in subjects with RA previously enrolled in study 20050168		144 Weeks

Secondary Outcomes

Measure	Description	Time Frame
To determine whether long-term use of AMG 108 improves function in subjects with RA		144 Weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Only subjects eligible for and completing 24 weeks of study 20050168 will be permitted to enroll.

Exclusion Criteria:

Subjects not eligible for or not completing 24 weeks of study 20050168 will be excluded.

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

References Module

Citations

Not provided

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