Arthritis - Clinical trial details 

Recruitment status:

Recruiting

Primary Sponsor:

University of Leeds

Recruitment countries:

United Kingdom

Health condition studied:

Rheumatoid Arthritis

URL:

Link to the clinical trial website

About the trial

Interventions:

Drug: Adalimumab

Key inclusion and exclusion criteria:

• 
  Inclusion Criteria:
  
  - Age = 18 years old
  
  - Confirmed Participation by Informed Consent
  
  - Patients fulfilling the ACR/EULAR classification criteria 2010 for rheumatoid
  arthritis (RA)
  
  Patients must be:
  
  - Within the first year of starting on methotrexate AND
  
  - Within 5 years of diagnosis AND
  
  - In a stable clinical disease activity state (clinical remission/LDAS /other physician
  deemed state) on methotrexate (as monotherapy or combination +/= prednisolone 5mg
  oral daily) for at least 8 successive weeks (with no change in Disease-Modifying
  Anti-Rheumatic Drugs (DMARD) +/steroid therapy - see exclusion criteria)
  
  - Female subjects must be either postmenopausal for at least 1 year, surgically
  incapable of childbearing, or effectively practicing an acceptable method of
  contraception (oral/parenteral /implantable hormonal contraceptives, intrauterine
  device or barrier and spermicide). Subjects must agree to use adequate contraception
  during the study and for at least 5 months after study completion (or longer if on
  relevant therapy and in line with local regulations).
  
  - Male subjects must agree to ensure they or their female partner(s) use adequate
  contraception during the study and for at least 5 months after the end of the study
  period.
  
  Exclusion Criteria
  
  - Patients not on a stable dose of methotrexate within 8 weeks of screening,
  intolerance or contraindications (as per clinician judgment)
  
  - Intramuscular, intraarticular or change in oral corticosteroid within 8 weeks of
  screening visit.
  
  - Oral Prednisolone dose > 5 mg within 8 weeks of screening
  
  - Treatment with any investigational agent within 4 weeks (or 5 halflives of the
  investigational drug, whichever is longer) of screening.
  
  - Patients who have previously received any biological therapy for RA.
  
  - History of severe allergic or anaphylactic reactions to human, humanised or murine
  monoclonal antibodies
  
  - Evidence of serious +/uncontrolled concomitant disease which in the investigator's
  judgment would deem the patient inappropriate for inclusion in the study: including
  (but not exclusively)including cardiovascular (NYHA class III/IV heart failure),
  nervous system (demyelination), pulmonary (including obstructive pulmonary disease,
  pulmonary fibrosis), renal, hepatic, endocrine (include uncontrolled diabetes
  mellitus) or gastrointestinal disease (including complicated diverticulitis,
  ulcerative colitis, or Crohn's disease.).
  
  - Known active current or history of recurrent bacterial, viral, fungal, mycobacterial
  or other infections (including but not limited to tuberculosis and atypical
  mycobacterial disease, Hepatitis B and C, and herpes zoster, but excluding fungal
  infections of nail beds).
  
  - Any major episode of infection requiring hospitalisation or treatment with IV
  antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to
  screening. Patients with persistent infections and patients at significant risk of
  infection (e.g. leg ulceration, indwelling urinary catheter, septic joint within 1
  year (or ever if prosthetic joint still in situ).
  
  - Active TB requiring treatment within the previous 3 years. Patients should be
  screened for latent TB (as per local guidelines) and, if positive, treated following
  local practice guidelines prior to commencing the study. Patients previously treated
  for tuberculosis with no recurrence in 3 years are permitted.
  
  - Primary or secondary immunodeficiency (history of or currently active) unless related
  to primary disease under investigation.
  
  12. Evidence of active malignant disease, malignancies diagnosed within the previous
  10 years (including haematological malignancies and solid tumours, except basal and
  squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has
  been excised and cured), or breast cancer diagnosed within the previous 20 years
  unless related to primary disease under investigation.
  

• Age minimum: 18 Years
• Age maximum: N/A
• Gender: Both

Primary outcomes:

Proportion of patients in whom there is a decrease in Power Doppler (PD) at week 48 after randomisation.

Secondary outcomes:

Total PD score at week 48

Target sample size:

400

Study type:

Interventional

Study design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Contacts:

• Name: Farah Khokhar-Cottrell
• Address:
• Phone: 44-7535-588-799
• Email: TURA@leeds.ac.uk
• Affiliation:

Technical details

Scientific title:

Targeted Ultrasound in Rheumatoid Arthritis

Sources of monetary support:

Please refer to primary and secondary sponsors

Secondary sponsors:

AbbVie
Theorem

Main ID:

NCT02056184

Secondary ID:

HG/1096
2013-002777-22
RR13/10787

Register:

ClinicalTrials.gov

Date of registration:

30/01/2025

Date of first enrollment:

December 2013

Last refreshed:

19 February 2025