Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA

niversity of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine0 sites400 target enrollmentNovember 28, 2013

DrugsHumira

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: niversity of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine
Enrollment: 400
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 28, 2013

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

niversity of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine

Eligibility Criteria

Inclusion Criteria

•1\. Patients fulfilling the ACR/EULAR classification criteria 2010 for RA
•Patients must be:
•2\. Within the two years of starting on methotrexate AND
•3\. Within 5 years of diagnosis AND
•4\. 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 before screening visit (with no change in DMARD \+/\- steroid therapy – see exclusion criteria)
•5\. On an acceptable (maximal tolerated) methotrexate dose, which, in the clinician's opinion, would justify escalation to adalimumab if a flare in disease activity occurs as detailed in the protocol
•6\. 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

•1\. Patients not on a stable dose of methotrexate within 8 weeks of screening, intolerance or contraindications (as per clinician judgment)
•2\. Intramuscular, intra\-articular or change in oral corticosteroid within 8 weeks of screening visit.
•3\. Oral Prednisolone dose \> 5 mg within 8 weeks of screening
•4\. Treatment with any investigational agent within 4 weeks (or 5 half\-lives of the investigational drug, whichever is longer) of screening.
•5\. Patients who have previously received any biological therapy for RA.
•6\. History of severe allergic or anaphylactic reactions to human, humanised or murine monoclonal antibodies
•7\. 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.).
•8\. 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).
•9\. 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).
•10\. Active tuberculosis (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.