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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:
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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

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

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Clinical response indicators [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety parameters [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00233571

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

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00233571     History of Changes
Other Study ID Numbers: DE018
Study First Received: September 13, 2005
Last Updated: November 21, 2011
Health Authority: Germany: Paul-Ehrlich-Institut

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

ClinicalTrials.gov processed this record on May 22, 2013