Open-Label Steroid Reduction Study of Adalimumab With Methotrexate in Patients With Active Rheumatoid Arthritis

Phase 4

Terminated

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT00233558
• Lead Sponsor: Abbott

Brief Summary

The purpose of the study is to evaluate the clinical efficacy of scheduled versus free reduction of steroid treatment in patients with active RA treated with adalimumab + MTX

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-10-05
• Study First Posted: 2005-10-06
• Status Verified: 2007-04
• Last Update Submitted: 2007-04-23
• Last Update Posted: 2007-04-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Subject is age 18 or older and in good health (Investigator discretion) with a recent stable medical history
• Subject has a diagnosis of rheumatoid arthritis as defined by the 1987-revised ACR criteria

Exclusion Criteria

• Subject 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Corticoid reduction and DAS 28

Secondary Outcome Measures

Name	Time	Method
Patient reported outcomes
Clinical response indicators
Safety parameters

Trial Locations

Locations (1)

Global Medical Information - Abbott; 🇺🇸 North Chicago, Illinois, United States