Targeted Ultrasound in Rheumatoid Arthritis

NCT02056184 | Completed Phase 4 DMC

• 3 other identifiers: HG/1096RR13/107872013-002777-22
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether therapy modifications (including addition of ultrasound-guided treatment change) can change imaging results in patients with early rheumatoid arthritis in a stable clinical disease activity state.

Conditions

Rheumatoid Arthritis; Targeted Ultrasound

Outcome Measures

Primary Outcomes (1)

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

  Week 48

Secondary Outcomes (1)

• Total PD score at week 48

  Week 48

Other Outcomes (8)

• GS (Grey Scale ultrasound)) at week 48

  Week 48

• X-ray scores at 48 and 96 weeks.

  Weeks 48 and 96

• HAQ-DI scores at 48 and 96 weeks

  Weeks 48 and 96

Study Arms (2)

Adalimumab, masked ultrasound

ACTIVE COMPARATOR

Adalimumab and blinded ultrasound.

Drug: Adalimumab

Adalimumab, unmasked ultrasound

EXPERIMENTAL

Adalimumab and open ultrasound.

Drug: Adalimumab

Interventions

Adalimumab DRUG

Also known as: Humira

Adalimumab, masked ultrasound; Adalimumab, unmasked ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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
• 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.
• \. 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.

Sponsors & Collaborators

• University of Leeds: lead
• AbbVie: collaborator
• Theorem: collaborator

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: February 5, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: July 1, 2019
• Last Updated: October 31, 2019

Record last verified: 2019-10

Locations

GB (1)