NCT00660647

Optimized Treatment Algorithm for Patients With Early Rheumatoid Arthritis (RA)

Optimized Treatment Algorithm in Early Rheumatoid Arthritis: Methotrexate and Intra-articular Glucocorticosteroid Plus Adalimumab or Placebo in the Treatment of Early Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Optimized treatment algorithm in early rheumatoid arthritis: Methotrexate and intra-articular glucocorticosteroid plus adalimumab or placebo in the treatment of early rheumatoid arthritis. A Randomised, double-blind and placebo-controlled, two arms, parallel group study of the additive effect of adalimumab concerning inflammatory control and inhibition of erosive development. Optimized Treatment Algorithms for Patients with Early RA

Detailed description

In newly diagnosed rheumatoid arthritis patients it is recommended to treat as soon as possible with methotrexate and steroids However, this treatment algorithm, will only bring one third of the patients into remission and cannot stop progressive, persistent joint damage. The possible benefits and risks of adding adalimumab to this conventional treatment algorithm is unknown. The aim of the study is to clarify the possible benefits of adding adalimumab an anti-TNF-alfa inhibitor versus placebo to the treatment of rheumatoid arthritis patients, who are treated very early and given methotrexate and intraarticular triamcinolone hexacetonide. Efficacy will be evaluated by DAS 28, ACR 20/50/70, HAQ, progressive changes in X-ray, MRI and DXA-scans. Adverse events will also be registered.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	Adalimumab	Adalimumab injection 0.8 ml (40 mg) s.c. every second week in up to 2 years
DRUG	Placebo	Saline injection 0.9%, 0.8 ml s.c. every second week up to 2 years

Timeline

• Start date: 2007-09-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2008-04-17
• Last updated: 2015-11-24

Locations

1 site across 1 country: Denmark