Infliximab as Induction Therapy in Early Rheumatoid Arthritis (IDEA)

Inclusion Criteria: * Men \& Women 18-80 years of age. * Fulfil 1987 ACR criteria for RA. * Symptoms of \> 3 months and \< 12 months duration. * Men and women must use adequate birth control measures for the duration of the study and should continue such precautions for 6 months after receiving the last infusion or dose of methotrexate. * The patient must be able to adhere to the study visit schedule and other protocol requirements. * The patient must be capable of giving informed consent and the consent must be obtained prior to any screening procedures. * Must have a chest radiograph within 3 months prior to first treatment dose with no evidence of malignancy, infection or fibrosis. * Are considered eligible according to the tuberculosis (TB) eligibility assessment. * Active disease as defined by DAS \> 2.4. * TNF therapy naïve. * DMARD therapy naïve. * Negative hepatitis B and C screening tests within 3 months prior to screening. Exclusion Criteria: * Women who are pregnant, nursing, or men or women planning pregnancy within 24 months after screening. * Use of any investigational (unlicensed) drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer. * Previous or current treatment with any other therapeutic agent targeted at reducing TNF. * Prior treatment with any DMARD. * Serious infections (such as pneumonia or pyelonephritis) in the previous 3 months. * Documented HIV infection. * Hepatitis- B or Hepatitis-C serology positive (must be checked within 3 months prior to screening). * Are considered ineligible according to the TB eligibility assessment. * Have or have had an opportunistic infection within 6 months prior to screening. * Significant haematological or biochemical abnormality. * Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease. * Concomitant congestive heart failure, including medically controlled asymptomatic patients. * Presence of a transplanted organ (with the exception of a corneal transplant \> 3 months prior to screening). * Malignancy within the past 5 years. * History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease. * Known recent substance abuse (drug or alcohol). * Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling during the study period. * Have a chest radiograph at screening that shows evidence of malignancy, infection, or any abnormalities suggestive of TB. * Have a positive Mantoux test or evidence of active TB infection, or recent close contact with an individual with active TB. * Previous oral, IM, IA or IV corticosteroids within 1 month prior to baseline. * Receiving treatment with anakinra. * Contra-indications to methotrexate, infliximab or steroids.