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

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Biological

Other names: ABT-D2E7, adalimumab, Humira

Primary outcomes

Clinical response indicators

Time frame: 5 years

Secondary outcomes

Safety parameters

Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study 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)

Important dates

Study start: 2000
Primary completion: 2006
Study completion: 2006
First posted: Oct 6, 2005
Registry last updated: Nov 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed