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

Rheumatoid Arthritis Clinical Trial

Official title:

Multicentre, Randomised, Open Label Study Comparing a “Scheduled Steroid Reduction Strategy” Versus a Free Steroid Reduction Strategy (Physician’s Usual Practice for Reducing Steroids) in Patients With Active RA Treated With Humira 40 mg Eow + MTX During 9 Months

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00233558
• Other study ID #: FRAN-04-002
• Status: Terminated
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: April 23, 2007
• Start date: June 2005

Study information

• Verified date: April 2007
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 160
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• adalimumab (up to 9 months exposure)

• methotrexate

Locations

Country	Name	City	State
United States	Global Medical Information - Abbott	North Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corticoid reduction and DAS 28
Secondary	Patient reported outcomes
Secondary	Clinical response indicators
Secondary	Safety parameters