Oligoarthritis Clinical Trial
— ADEOSOfficial 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)
| Verified date | November 2019 |
| Source | University of Leeds |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 22 |
| Est. completion date | January 16, 2017 |
| Est. primary completion date | January 16, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Leeds Teaching Hospitals NHS Trust | Leeds | West Yorkshire |
| Lead Sponsor | Collaborator |
|---|---|
| University of Leeds | Abbott |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Patients in remission at 24 weeks. | Number in remission at 24 weeks (absence of clinical-evidence synovitis (no tender/swollen joints) & CRP< 5mg/ml) | 24 weeks | |
| Secondary | Complete response at 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 | Weeks 12, 36, 48, 72 and 96. | |
| Secondary | Disease Activity Score at weeks 12, 24, 36, 48, 72 and 96 | Disease Activity Score at weeks 12, 24, 36, 48, 72 and 96 | Weeks 12, 24, 36, 48, 72 and 96 | |
| Secondary | Ultrasonographical features (erosions) at weeks 2 and 24 | Ultrasonographical features (erosions) at weeks 2 and 24 | Week 2 and 24 | |
| Secondary | Health Assessment Questionnaire at weeks 0, 12 24, 36, 48, 72 and 96 | Health Assessment Questionnaire at weeks 0, 12 24, 36, 48, 72 and 96 | Week 0, 12 24, 36, 48, 72 and 96 | |
| Secondary | EQ-5D (Euro-QoL) questionnaire at weeks 0, 12 24, 36, 48, 72 and 96 | EQ-5D (Euro-QoL) questionnaire at weeks 0, 12 24, 36, 48, 72 and 96 | Week 0, 12 24, 36, 48, 72 and 96 | |
| Secondary | Work Instability Scale at weeks 0, 12, 24, 36, 48, 72 and 96 | Work Instability Scale at weeks 0, 12, 24, 36, 48, 72 and 96 | weeks 0, 12, 24, 36, 48, 72 and 96 | |
| Secondary | Plain radiography at weeks -2, 24 and 96 | Plain radiography at weeks -2, 24 and 96 | weeks -2, 24 and 96 |