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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

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

Page last updated: August 20, 2015

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