Infliximab as Induction Therapy in Early Rheumatoid Arthritis (IDEA) — IDEA  

Rheumatoid Arthritis Clinical Trial

Official title: A Multi-centre Randomised Double Blind Placebo Controlled Study Comparing Two Regimens of Combination Therapy in Early DMARD Naive Rheumatoid Arthritis.

Status Completed

Clinical Trial Summary

This is a placebo controlled randomised clinical trial.Patients attending Yorkshire Early Arthritis Clinics and diagnosed with rheumatoid arthritis with symptom duration of 3−12 months will be recruited. They will be randomised to blinded therapy with either methotrexate and intravenous corticosteroid at baseline, or methotrexate and intravenous infliximab according to the standard treatment regime. Patients will be followed regularly, and at each visit, if the patients are not in remission, they will be given an intramuscular injection of corticosteroid. After 26 weeks, all patients will be unblinded and those with an inadequate treatment response will be treated according to a dose escalation algorithm until they achieve remission. Those in remission will continue on blinded therapy and if 6 months of remission is achieved the intravenous agent (infliximab or placebo) will be withdrawn.

Clinical Trial Description

The main aim of the study is to compare the efficacy of biologic therapy (infliximab) as induction therapy against current best practice therapy: early introduction of methotrexate in combination with steroid induction therapy and dose modification according to predefined disease activity measures (as informed by the literature, and based around a pragmatic dose escalation protocol).

Exploratory analyses of imaging findings will be undertaken on a subgroup of patients at sites able to perform such assessments.

The imaging techniques used include

1. DEXA

2. US

3. Peripheral MRI

End point

The end points of the study are defined as:

• Completion of 78 weeks of therapy in the study

• Withdrawal due to any reason including toxicity or inefficacy

• Withdrawal due to completion of the dose escalation regime and disease remains active

• Withdrawal due to meeting NICE criteria for biologics during the dose escalation regime

At the end of the study, patients will continue to be followed in the Yorkshire Rheumatology clinics as part of their routine care.

All patients who withdraw will be asked to have a withdrawal visit with X-Rays of hands and feet to allow assessment of the primary endpoint. ;

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

• NCT number: NCT01308255
• Study type: Interventional
• Source: University of Leeds
• Status: Completed
• Phase: Phase 4
• Start date: September 2006
• Completion date: February 2011