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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:
ClinicalTrials.gov Identifier:
NCT00233571
First Posted: October 6, 2005
Last Update Posted: November 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Abbott
  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 Biological: Adalimumab 40 mg subcutaneous (SC) every other week (EOW) Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Clinical response indicators [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Safety parameters [ Time Frame: 5 years ]

Enrollment: 796
Study Start Date: June 2000
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adalimumab 40mg subcutaneous (SC) every other week (EOW)
Adalimumab 40mg subcutaneous (SC) every other week (EOW)
Biological: Adalimumab 40 mg subcutaneous (SC) every other week (EOW)
Other Names:
  • ABT-D2E7
  • adalimumab
  • Humira

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00233571


Sponsors and Collaborators
Abbott
Investigators
Study Director: Hartmut Kupper, MD Abbott
  More Information

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00233571     History of Changes
Other Study ID Numbers: DE018
First Submitted: September 13, 2005
First Posted: October 6, 2005
Last Update Posted: November 22, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents