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ADalimumab in Persistent Early Oligoarthrits Study (ADEOS) (ADEOS)

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ClinicalTrials.gov Identifier: NCT04154852
Recruitment Status : Completed
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Dr Ai Lyn Tan, University of Leeds

Brief 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.


Condition or disease Intervention/treatment Phase
Oligoarthritis Drug: Adalimumab Drug: Methotrexate Drug: Placebo Drug: Folic Acid Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Study Start Date : June 2011
Actual Primary Completion Date : January 16, 2017
Actual Study Completion Date : January 16, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TNF-antagonist
Adalimumab, 40 mg, 2-weekly Methotrexate, rapid escalation to 25mg, weekly Folic Acid 5mg, 6 days a week
Drug: Adalimumab
Drug: Methotrexate
Drug: Folic Acid
Active Comparator: Placebo + MTX
Placebo, 2 weekly Methotrexate, rapid escalation to 25mg, weekly Folic Acid 5mg, 6 days a week
Drug: Methotrexate
Drug: Placebo
Placebo to replace adalimumab

Drug: Folic Acid



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154852


Locations
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United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, United Kingdom, LS7 4SA
Sponsors and Collaborators
University of Leeds
Abbott
Investigators
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Principal Investigator: Dr Ai Lyn Tan University of Leeds
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Responsible Party: Dr Ai Lyn Tan, Chief Investigator, University of Leeds
ClinicalTrials.gov Identifier: NCT04154852    
Other Study ID Numbers: RR08/8685
2008-004877-17 ( EudraCT Number )
10060 ( Other Identifier: UKCRN )
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Folic Acid
Adalimumab
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents
Hematinics
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances