A Long Term Roll-over Study to Investigate the Efficacy and Safety of Adalimumab Given Long-term to Patients With Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00233571
• Date of registration: 13/09/2005
• Prospective Registration: No
• Primary sponsor: Abbott
• Public title: A Long Term Roll-over Study to Investigate the Efficacy and Safety of Adalimumab Given Long-term to Patients With Rheumatoid Arthritis
• Scientific 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)
• Date of first enrolment: June 2000
• Target sample size: 796
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00233571
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Contacts

• Name: Hartmut Kupper, MD
• Affiliation: Abbott

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Biological: Adalimumab 40 mg subcutaneous (SC) every other week (EOW)

Primary Outcome(s)

Clinical response indicators [Time Frame: 5 years]

Secondary Outcome(s)

Safety parameters [Time Frame: 5 years]

Secondary ID(s)

DE018

Source(s) of Monetary Support

Please refer to primary and secondary sponsors