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.

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00233571

Purpose

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

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: adalimumab	Phase III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Adalimumab

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	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)

Further study details as provided by Abbott:

Primary Outcome Measures:

Secondary Outcome Measures:

Enrollment:	796
Study Start Date:	June 2000

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233571

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Beverly Paperiello

Abbott

More Information

Study ID Numbers:	DE018
Study First Received:	September 13, 2005
Last Updated:	August 29, 2008
ClinicalTrials.gov Identifier:	NCT00233571
Health Authority:	Germany: Paul-Ehrlich-Institut

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Adalimumab

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immune System Diseases
Therapeutic Uses
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009