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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

September 13, 2005
November 21, 2011
June 2000
June 2006   (final data collection date for primary outcome measure)
Clinical response indicators [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Clinical response indicators
Complete list of historical versions of study NCT00233571 on ClinicalTrials.gov Archive Site
Safety parameters [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Safety parameters
Not Provided
Not Provided
 
A Long Term Roll-over Study to Investigate the Efficacy and Safety of Adalimumab Given Long-term to Patients With Rheumatoid Arthritis
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)

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

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
Biological: Adalimumab 40 mg subcutaneous (SC) every other week (EOW)
Other Names:
  • ABT-D2E7
  • adalimumab
  • Humira
Experimental: Adalimumab 40mg subcutaneous (SC) every other week (EOW)
Adalimumab 40mg subcutaneous (SC) every other week (EOW)
Intervention: Biological: Adalimumab 40 mg subcutaneous (SC) every other week (EOW)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
796
June 2006
June 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00233571
DE018
No
Abbott
Abbott
Not Provided
Study Director: Hartmut Kupper, MD Abbott
Abbott
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP