ADalimumab in Persistent Early Oligoarthrits Study (ADEOS)

Conditions

• Oligoarthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Adalimumab — DRUG
• Methotrexate — DRUG
• Placebo — DRUG
  Placebo to replace adalimumab
• Folic Acid — DRUG

Study Details

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.

Key Dates

Start date

Jun 30, 2011

Status verified

Nov 2019

Primary completion

Jan 16, 2017

Completion

Jan 16, 2017

Study Design

Enrollment

22 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: TNF-antagonist
  Adalimumab, 40 mg, 2-weekly Methotrexate, rapid escalation to 25mg, weekly Folic Acid 5mg, 6 days a week
• Active Comparator: Placebo + MTX
  Placebo, 2 weekly Methotrexate, rapid escalation to 25mg, weekly Folic Acid 5mg, 6 days a week

Primary Outcome Measure

Patients in remission at 24 weeks. [ Time Frame: 24 weeks ]