A Long Term Roll-over Study to Investigate the Efficacy and Safety of Adalimumab Given Long-term to Patients With Rheumatoid Arthritis
Information source: Abbott
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: Adalimumab 40 mg subcutaneous (SC) every other week (EOW) (Biological)
Phase: Phase 3
Status: Completed
Sponsored by: Abbott Official(s) and/or principal investigator(s): Hartmut Kupper, MD, Study Director, Affiliation: Abbott
Summary
The purpose of the study is to assess the long-term safety and clinical efficacy of
adalimumab in patients with rheumatoid arthritis
Clinical Details
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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Clinical response indicators
Secondary outcome: Safety parameters
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: June 2000
Last updated: November 21, 2011
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