A controlled randomised double-blind multicentre study comparing two therapy strategies in disease modifying anti-rheumatic drug-naive early rheumatoid arthritis patients over 48 weeks: induction therapy with adalimumab and methotrexate over 24 weeks followed by methotrexate monotherapy up to week 48 versus methotrexate monotherapy

Charité - University Medicine Berlin (Germany)0 sites180 target enrollmentAugust 11, 2006

Overview

No summary available.

Registry

who.int

Start Date

August 11, 2006

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

Charité - University Medicine Berlin (Germany)

•Each patient must meet all of the following inclusion criteria to be enrolled into this study:
•1\. Patients with definite RA referring to the American College of Rheumatology (ACR) Classification Criteria of 1987 up to one year after first RA symptoms
•2\. Aged 18 to 70 years
•3\. Has active disease at the time of randomisation as indicated by: six from 68 tender and six from 66 swollen joints and at least one of the following two criteria:
•3\.1\. Westergren erythrocyte sedimentation rate (ESR) of 28 mm/hour
•3\.2\. C\-reactive protein (CRP) levels more than 1\.0 mg/dl
•4\. Has morning stiffness for longer than 30 minutes
•5\. No current or prior therapy with Disease Modifying Anti\-Rheumatic Drugs (DMARDs) or biologics
•6\. Non steroidal anti\-inflammatory drugs (NSAIDs) and corticosteroids treatment has to be stable two weeks prior to screening and during the trial with maximal less than or equal to 10 mg/d prednisolone equivalent
•7\. Is capable of understanding and signing an informed consent form

•Patients meeting any following exclusion criteria are not to be enrolled in this study:
•1\. Has significant concurrent medical diseases including cancer or a history of cancer (other than resected cutaneous basal and squamous cell carcinoma, in situ cervical cancer) in the last five years
•2\. Has uncompensated congestive heart failure, myocardial infarction within 12 months, unstable angina pectoris, uncontrolled hypertension,
•severe pulmonary disease, or history of human Immunodeficiency
•Virus (HIV) infection, immunodeficiency syndrome, other rheumatologic diseases than RA, or central nervous systems demyelinating events suggestive or multiple sclerosis
•3\. Received anti\-CD4, diphtheria interleukin\-2 fusion protein, anti\-interleukin\-6, rituximab or other immunsuppressive biologic before screening, and treatment with such agents if there are persistent signs of immunosuppression (with a subsequent abnormal absolute T\-cell count) at screening count
•4\. Received any live (attenuated) vaccines within four weeks of screening visit
•5\. Received intra\-articular corticosteroid injection within four weeks of screening
•6\. Received bolus intramuscular/intravenous treatment with corticosteroids
•(more than 10 mg prednisone or equivalent) within four weeks of screening visit