NCT01308255

Infliximab as Induction Therapy in Early Rheumatoid Arthritis (IDEA)

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: University of Leeds · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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on blinded therapy and if 6 months of remission is achieved the intravenous agent (infliximab or placebo) will be withdrawn.

Detailed 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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Infliximab	Prior to week 26 * Infliximab 3mg/kg standard regime (weeks 0, 2, 6, 14, 22) * Methotrexate commencing at 10mg weekly, progressing to 20mg by week 6. * Folic acid 5 mg daily except the day methotrexate is taken Patients will be unblinded at week 26 and then treated pragmatically guided by disease activity
DRUG	Methylprednisolone	Steroid
DRUG	Methotrexate	All patients enrolled are commenced on oral methotrexate 10mg once a week The methotrexate dose should be increased to 15 mg at the week 2 visit. The methotrexate should be increased to 20mg at the week 6 visit.
DIETARY_SUPPLEMENT	Folic acid	All patients enrolled are commenced on oral folic acid 5mg daily, except the day methotrexate is taken, and the study infusions.

Timeline

• Start date: 2006-09-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2011-03-04
• Last updated: 2019-11-01

Locations

1 site across 1 country: United Kingdom