Infliximab as Induction Therapy in Early Rheumatoid Arthritis (IDEA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

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      remission is achieved the intravenous agent (infliximab or placebo) will be withdrawn.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.
    

Intervention name(s): Infliximab; Methylprednisolone; Methotrexate; Folic acid
Intervention type(s): Drug; Drug; Drug; Dietary Supplement
Intervention description(s): 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; Steroid; 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.; All patients enrolled are commenced on oral folic acid 5mg daily, except the day methotrexate is taken, and the study infusions.
Other intervention name(s): Remicade; Medrol, Solu-Medrol and Cadista.; Maxtrex; vitamin B9,vitamin Bc, or folacin
Intervention MeSH terms: Vitamins; Folic Acid; Methylprednisolone; Methylprednisolone Hemisuccinate; Infliximab; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment