A Long Term Roll-over Study to Investigate the Efficacy a... | NCT00233571

Studies
A Long Term Roll-over Study to Investigate the Efficacy and Safety of Adalimumab Given Long-term to Patients With Rheumatoid Arthritis

NCT00233571

Sponsor

Abbott

Status

Completed

Last Update Posted

Nov 22, 2011Estimated

Enrollment

796Actual

Phase

Phase 3

Conditions

Rheumatoid Arthritis

Interventions

Adalimumab 40 mg subcutaneous (SC) every other week (EOW)

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

Nov 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

Jun 2000

Primary Completion Date

Jun 2006Actual

Completion Date

Jun 2006Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Oct 5, 2005

First Posted Date

Oct 6, 2005Estimated

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

Nov 21, 2011

Last Update Posted Date

Nov 22, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to assess the long-term safety and clinical efficacy of adalimumab in patients with rheumatoid arthritis

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

796Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adalimumab 40mg subcutaneous (SC) every other week (EOW)	Experimental	Adalimumab 40mg subcutaneous (SC) every other week (EOW)	Biological: Adalimumab 40 mg subcutaneous (SC) every other week (EOW)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adalimumab 40 mg subcutaneous (SC) every other week (EOW)	Biological		Adalimumab 40mg subcutaneous (SC) every other week (EOW)

Measure	Description	Time Frame
Clinical response indicators		5 years

Measure	Description	Time Frame
Safety parameters		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Completion of a previous D2E7 study
Subject is in good health (Investigator discretion) with a recent stable medical history

Exclusion Criteria:

Former enrollment in this trial (DE018)
Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study
Female subject who is pregnant or breast feeding or considering becoming pregnant.

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
Hartmut Kupper, MD	Abbott	Study Director

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

Intervention Browse Module

MeSH Terms

ID	Term
D000068879	Adalimumab
D007279	Injections, Subcutaneous

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided