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NCT Number: NCT04154852

ADalimumab in Persistent Early Oligoarthrits Study (ADEOS)

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.

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Key information

Conditions

Oligoarthritis Arthritis Joint Diseases Musculoskeletal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS7 4SA, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects presenting at the rheumatology clinic who meet all of the following criteria will be considered for enrolment into the study:-

  • Male and female patients aged between 18 and 80 years.
  • Oligoarthritis defined as inflammatory arthritis affecting ≤ 4 joints
  • At least 1 large joint involvement (wrist, elbow, shoulder, knee or ankle)
  • Disease duration of less than 12 months
  • Patients on NSAIDs must have remained on an unchanged regimen for at least 28 days prior to study drug administration.
  • Patients must be able and willing to comply with the terms of this protocol.
  • Informed consent must be obtained in writing for all subjects at enrolment into the study.

Exclusion criteria

  • Patients who have > 12 months disease duration
  • Exclude if DIP joint alone
  • Evidence of osteoarthritis
  • Diagnosis of gout
  • Previous treatment with a DMARD therapy.
  • Change in NSAID dose within the last 28 days
  • Previous treatment with oral, intra-muscular or intra-articular steroid
  • Patients unwilling or unable to receive adalimumab or MTX or both for the duration of the study.
  • Planned surgery within 12 months of study initiation.
  • Patients with moderate to severe heart failure
  • Suspicion of diagnosis of tuberculosis (positive tuberculosis test (>5mm in duration if previous BCG or >10mm if no previous BCG) or abnormal chest x-ray)

Treatment and study plan

Adalimumab

Drug

methotrexate

Drug

Placebo

Drug

Placebo to replace adalimumab

Folic Acid

Drug

Primary outcomes

  1. Patients in remission at 24 weeks.

    Time frame: 24 weeks

    Number in remission at 24 weeks (absence of clinical-evidence synovitis (no tender/swollen joints) & CRP< 5mg/ml)

Secondary outcomes

  1. Complete response at weeks 12, 36, 48, 72 and 96

    Time frame: Weeks 12, 36, 48, 72 and 96.

    Complete response (absence of clinical-evidence synovitis & CRP< 5mg/ml) at weeks 12, 36, 48, 72 and 96

  2. Disease Activity Score at weeks 12, 24, 36, 48, 72 and 96

    Time frame: Weeks 12, 24, 36, 48, 72 and 96

    Disease Activity Score at weeks 12, 24, 36, 48, 72 and 96

  3. Ultrasonographical features (erosions) at weeks 2 and 24

    Time frame: Week 2 and 24

    Ultrasonographical features (erosions) at weeks 2 and 24

  4. Health Assessment Questionnaire at weeks 0, 12 24, 36, 48, 72 and 96

    Time frame: Week 0, 12 24, 36, 48, 72 and 96

    Health Assessment Questionnaire at weeks 0, 12 24, 36, 48, 72 and 96

  5. EQ-5D (Euro-QoL) questionnaire at weeks 0, 12 24, 36, 48, 72 and 96

    Time frame: Week 0, 12 24, 36, 48, 72 and 96

    EQ-5D (Euro-QoL) questionnaire at weeks 0, 12 24, 36, 48, 72 and 96

  6. Work Instability Scale at weeks 0, 12, 24, 36, 48, 72 and 96

    Time frame: weeks 0, 12, 24, 36, 48, 72 and 96

    Work Instability Scale at weeks 0, 12, 24, 36, 48, 72 and 96

  7. Plain radiography at weeks -2, 24 and 96

    Time frame: weeks -2, 24 and 96

    Plain radiography at weeks -2, 24 and 96

Sponsors and collaborators

Lead sponsor

University of Leeds

Other

Collaborators

  • Abbott

Registry information

Official study title

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

Acronym: ADEOS

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Nov 7, 2019
Registry last updated
Nov 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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