ADEOS - ADalimumab in persistent Early Oligoarthrits Study

• Research type

  Research Study

• Full title

  Prospective, Single-centre, Double-Blind, Randomised, Placebo-controlled Study Evaluating Efficacy of Adalimumab + Methotrextate Compared with Placebo + Methotrexate in Patients with Early Oligoarthritis

• IRAS ID

  524

• Contact name

  Ai Lyn Tan

• Sponsor organisation

  University of Leeds

• Eudract number

  2008-004877-17

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The purpose of this study is to investigate adalimumab, a drug that is currently licensed for treatment of patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and inflammatory bowel disease (Crohn??s disease). It is a protein (human monoclonal antibody) that is designed to block the effects of an inflammatory cytokine, tumour necrosis factor alpha (TNF alpha) which is a causative factor in joint inflammation. It is given as a subcutaneous injection. Management of established rheumatoid arthritis has been transformed with the use of TNF-antagonists, the first in the class of biological agents. The benefits in early RA are also continuing to emerge. Oligoarthritis represents a sub-group of early inflammatory arthritis that warrants more effective treatment strategy including the potential to modulate the disease course and halt further progression. The TNF-antagonists offer the potential of achieving this, justifying this initial investigation.Hence, this study is designed to establish the benefit of adalimumab in preventing progression of oligoarthritis. The primary aim of the study is to assess how many patients achieve remission i.e. no further evidence of joint inflammation or damage. We will do this by including patients who present with inflammation of four or less joints who do not fulfil criteria for a definite arthritis condition such as rheumatoid arthritis. We will perform clinical, laboratory (blood tests) and imaging assessments at regular intervals on these patients to check on safety of the study drug adalimumab and evaluate any changes in disease activity that may have resulted from use of adalimumab. All patients will receive treatment with a standard therapy (methotrexate) with randomisation of half of the patients to receive the active study drug, adalimumab as additional treatment for six months.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  09/H1307/99

• Date of REC Opinion

  12 Apr 2010

• REC opinion

  Further Information Favourable Opinion