ADalimumab in Persistent Early Oligoarthrits Study (ADEOS)
Status:
Completed
Trial end date:
2017-01-16
Target enrollment:
Participant gender:
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
TNFantagonists, the first in the class of biological agents. The benefits in early RA are
also continuing to emerge. Oligoarthritis represents a subgroup of early inflammatory
arthritis that warrants more effective treatment strategy including the potential to modulate
the disease course and halt further progression. The TNFantagonists 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. The investigators
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. The
investigators 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.
Phase:
Phase 2
Details
Lead Sponsor:
University of Leeds
Collaborator:
Abbott
Treatments:
Adalimumab Folic Acid Methotrexate Vitamin B Complex