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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Abbott

ClinicalTrials.gov Identifier:

NCT00233571

First received: September 13, 2005

Last updated: November 21, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

November 21, 2011

Start Date ^ICMJE

June 2000

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Clinical response indicators [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Clinical response indicators

Change History

Complete list of historical versions of study NCT00233571 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety parameters [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Safety parameters

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Multi-Centre Open Label Continuation Study With Subcutaneous D2E7 (Adalimumab) for Patients With Rheumatoid Arthritis Who Completed a Preceding Clinical Study With D2E7 (Adalimumab)

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Rheumatoid Arthritis

Intervention ^ICMJE

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

Other Names:

ABT-D2E7
adalimumab
Humira

Study Arm (s)

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

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

Intervention: Biological: Adalimumab 40 mg subcutaneous (SC) every other week (EOW)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

796

Completion Date

June 2006

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00233571

Other Study ID Numbers ^ICMJE

DE018

Has Data Monitoring Committee

Responsible Party

Abbott

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Hartmut Kupper, MD

Abbott

Information Provided By

Abbott

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top