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

This is an interventional treatment trial for Rheumatoid Arthritis Read More

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.