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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

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.
ClinicalTrials.gov Identifier: NCT00233571
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : November 22, 2011
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: Adalimumab 40 mg subcutaneous (SC) every other week (EOW) Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 796 participants
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)
Study Start Date : June 2000
Primary Completion Date : June 2006
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Study Director: Hartmut Kupper, MD Abbott
More Information

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

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