Multicenter Randomized Prospective Trial Comparing Methotrexate Alone or in Combination With Adalimumab in Early Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Methotrexate Alone Versus Methotrexate in Combination With Adalimumab in Early Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00291915
• Other study ID #: GUEPARD-GERCER 2122
• Status: Recruiting
• Phase: Phase 4
• First received: February 14, 2006
• Last updated: February 14, 2006
• Start date: May 2004
• Est. completion date: March 2007

Study information

• Verified date: February 2006
• Source: Goupe d'Etudes et de Recherche Clinique En Rhumatologie
• Contact: Maxime r DOUGADOS, MD
• Phone: 00 33 1 58 41 25 62
• Email: maxime.dougados[@]cch.aphp.fr
• 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

Evaluation of two treatment modalities in early potentially severe early arthritis ( Methotrexate alone or in combination with adalimumab)

Description:

Patients: early ( less than 6 months), active ( DAS>5.2),potentially severe ( Leiden score>6) Study design:12 months, prospective , randomized, open Study treatments: Methotrexate at a weekly dose of 0.3mg/kilo alone or in combination with adalimumab 40 mg every the other week Outcome measures: DAS over the 12 months

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Early Active Potentially severe arthritis

Exclusion Criteria:

• contra indication of methotrexate or anti TNF

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Adalimumab

• Methotrexate

Locations

Country	Name	City	State
France	Hopital Cochin	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Goupe d'Etudes et de Recherche Clinique En Rhumatologie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Activity Score
Secondary	-Radiological score
Secondary	-Functional impairment ( HAQ)
Secondary	-Pain (VAS)