A double blind, randomised, placebo controlled, multicentre trial of Anti-Tumour Necrotising Factor alpha (Anti-TNFa) chimeric monoclonal antibody (infliximab, Remicade®) in combination with methotrexate in patients with very early inflammatory arthritis

Medical University of Vienna (Austria)0 sites89 target enrollmentDecember 18, 2007

Overview

Registry

who.int

Start Date

December 18, 2007

End Date

October 7, 2013

Last Updated

7 years ago

Study Type

Interventional

Sex

All

Sponsor

Medical University of Vienna (Austria)

•All patients to be included into this trial must meet the following inclusion criteria:
•1\. Men and women, between 18 and 75 years of age, capable of understanding and signing an informed consent
•2\. The presence of arthritis:
•2\.1\. Must be established in a rheumatology centre
•2\.2\. Must be present in at least two joints of the 66 joint count, of which at least one joint must be an Metacarpophalangeal\- (MCP\-), or a Proximal Interphalangeal\- (PIP\-) (Interphalangeal\- \[IP\-]), or a wrist\- or a Metatarsophalangeal\- (MTP\-) joint. Two MTP\-joints will not suffice. Any kind of polyarthritis (\= 6 joints of any kind) will be sufficient
•2\.3\. Without any previous episodes of inflammatory joint disease
•3\. Duration of symptoms:
•3\.1\. Must be reported by the subject and should involve the inflamed joints described under point 2
•3\.2\. Must be 2 weeks at least
•3\.3\. Must be 16 weeks at most, as reported by the subject, including the observation period of at least 2 weeks by the physician

•Patients must not:
•1\. Have arthritis with a distinct diagnosis, made after a routine diagnostic work\-up (examples are Systemic Lupus Erythematosus \[SLE], psoriatic arthritis, systemic sclerosis, gout, pseudogout, Lyme arthritis, reactive arthritis, Parvo viral arthritis)
•2\. Be incapacitated, largely or wholly bedridden, or confined to a wheelchair, or have little or no ability for self care
•3\. Weigh more than 100 kg
•4\. Use glucocorticoids greater than 10 mg/day prednisone or equivalent
•5\. Have received intramuscular or intra\-articular injection of steroids in the previous month
•6\. Have screening laboratory test results as follows:
•6\.1\. White Blood Cells (WBCs) less than 3\.0 x 10^9 cells/L
•6\.2\. Platelets less than 100 x 10^9 cells/L
•6\.3\. Serum creatinine greater than 1\.4 mg/dL