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Infliximab as Induction Therapy in Early Rheumatoid Arthritis (IDEA)

NCT01308255 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2019-11-01

No results posted yet for this study

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on blinded therapy and if 6 months of remission is achieved the intravenous agent (infliximab or placebo) will be withdrawn.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Leeds

    lead OTHER

Principal Investigators

  • Paul Emery · University of Leeds

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01308255 on ClinicalTrials.gov